Single-incision robotic assisted surgery: a nonrandomized cohort pilot study on a novel surgical platform in colorectal surgery

Abstract

Background:

The technological barriers and steep learning curve of single-incision laparoscopic surgery had kept it from further applications. A literature review had reported that robotic technology could preserve its advantages while simplifying its difficulties. This nonrandomized cohort pilot study aims to evaluate the feasibility and safety of single-incision robotic assisted colorectal surgery based on a novel robotic surgical platform, the SHURUI Endoscopic Surgical Robotic System (SR-ENS-600).

Method:

This study enrolled 7 patients with colorectal malignancy who underwent single-incision robotic assisted surgery (SIRAS) at a tertiary general surgery center, and retrospectively included 23 patients who underwent robotic assisted surgery from September 2015 to June 2016 and 35 patients who underwent single-incision laparoscopic surgery from June 2017 to March 2018, which were labeled as the initial in-learning-curve attempts from the same surgical team. The technological feasibility and safety of SIRAS were evaluated. Perioperative outcomes, short-term postoperative outcomes, clinicopathologic outcomes, and follow-up were reported.

Results:

Six SIRAS operations were completed successfully without eventful intraoperative complications, except for one operation that encountered a large-volume of intraoperative hemorrhage. Two SIRAS cases were converted to multiport laparoscopic surgery because of intraoperative hemorrhage and difficulty in retraction. Postoperative pathology reported satisfactory specimen qualities. There were no short-term postoperative complications, no short-term mortality, no tumor recurrence, or metastasis reported. There was one incisional hernia reported half a year after operation. Patients with advanced staging were sent to standard evaluation and chemotherapy, and follow-up is still on-going.

Conclusions:

SIRAS can be feasibly performed by a skilled surgical team via the SR-ENS-600 platform for strictly-selected patients, which provides preferable instrument maneuverability and stability in confined surgical fields and overcomes the technical difficulty of multisite dissection through a single-incision. Large-volume investigations and high-level evidences are required to further validate its safety and superiority.

Introduction

Highlights

• The robotic surgical platform, which is compatible with both multiport laparoscopic surgery and single-incision laparoscopic surgery (SILS) is lacking.

• The novel single-incision robotic surgical system, the SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) is equipped with four separate snake-like robotic arms constructed on a dual continuum configuration, offering sufficient payload capacity, maneuverability, and compatibility with multiport surgery.

• This study first reported the initial experiences of single-incision robotic assisted surgery (SIRAS) in the field of colorectal surgery via the novel robotic surgical system, the SR-ENS-600.

• This study first compared the perioperative outcomes and short-term postoperative outcomes of the first in-learning-curve attempts from the group of SIRAS with SILS, as well as multiport robotic assisted surgery, which provides the firsthand information of safety and feasibility on this novel surgical platform for further larger-volume investigation.

• The SIRAS is a promising alternative and a step forward in the combination of SILS and robotic surgery in general surgery.

Since the introduction of conventional multiport laparoscopic surgery, surgeons’ enthusiasm for minimizing the invasiveness of surgical interventions has never been impeded. In pursuing for improved cosmesis, less perioperative pain, earlier recovery, and reduced port-related complications, much effort has been done on port subtraction without sacrifice of operative and oncologic safety, which led to the inception of single-incision laparoscopic surgery (SILS)¹. Till now, SILS has been validated for its feasibility and safety in limited operations, such as cholecystectomy and appendicectomy^2–5. Although considered as a feasible alternative, the further application of SILS in technological demanding operations encountered obstacles, such as loss of triangulation, amplified tremor as well as poor exposure and retraction in confined surgical fields. However, difficulties did not stop surgeons there but ignited their passionate combination of SILS and robotic surgical platform to create a novel branch of minimally invasive surgery, the single-incision robotic assisted surgery (SIRAS). With its unique advantages of magnified 3D vision, reduction of tremor transmission and instrument maneuverability and stability, robotic platform can adopt the strengths of SILS and bring them into full play, meanwhile overcome the recognized technological difficulties. A review of current literature has shown the superiority of SIRAS and there were evidences from randomized controlled trials and prospective trials had proven its safety and feasibility in gallbladder surgery^6–8.

In terms of general surgery, conventional multiport laparoscopic surgery has been proven to supersede traditional open surgery as the gold standard surgical intervention of oncologic treatment^9–12. Although with better cosmesis, faster recovery, less port-related complications, and comparable short-term outcomes^13–17, the further application of SILS in general surgery was decelerated by technical barriers. Currently, in general surgery there are various case reports and series addressing SIRAS sprung up in the literature, mainly based on the Da Vinci Si, Xi, or SP platform, which reported encouraging outcomes^18–29. In this paper, we report our initial experiences and techniques of SIRAS in general surgery based on a novel robotic surgical platform, the SR-ENS-600 platform (Beijing Surgerii Technology Co., Ltd.) (Fig. 1).

Figure 1.

The sketch of SR-ENS-600 platform. (A) Surgeon console. (B) Patient-side cart.

Method

Patient enrollment and exclusion

This pioneering exploration on this novel surgical platform was conducted on seven patients with colorectal malignancy who underwent SIRAS from March to September 2022, which is a nonrandomized cohort pilot study objective to examinate the feasibility and safety of the SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) in colorectal surgery. In addition, 23 patients with colorectal malignancy who underwent multiport robotic assisted surgery (RAS) based on the Da vinci Xi platform from September 2015 to June 2016, as well as another 35 patients who underwent SILS from June 2017 to March 2018, were retrospectively included in this study, where the total 58 cases were labeled as the initial in-learning-curve attempts from the same surgical team.

Inclusion criteria of the SIRAS group included age 18–75, BMI ranged 18.5–29.5 kg/m², American Society of Anesthesiologists (ASA) classed I–III, cT1–T3N0M0 tumor with a maximum diameter 6 cm or less located at the colon or rectum above the retroperitoneal reflection in accordance with the indications of conventional laparoscopic surgery, ability to cooperate in inspections and follow-up, willingness to participate in the trial and providing informed consent. Exclusion criteria of SIRAS group included emergency, pregnancy, inability to cooperate and provide consent, history of neoadjuvant treatment, advanced or metastatic oncological diseases, with systemic diseases unsuitable for surgical interventions and other contradictions of conventional laparoscopic surgery.

Inclusion criteria of RAS group and the SILS group included age 18–75, BMI ranged 18.5–29.5 kg/m², American Society of Anesthesiologists (ASA) classed I–III, cT1–T4N1M0 tumor located at the colon or rectum above the retroperitoneal reflection in accordance with the indications of conventional laparoscopic surgery, and the surgery was the initial in-learning-curve attempts performed by the same surgical team (within the first 40 attempts of each surgical approach). Exclusion criteria of RAS group and the SILS group included emergency, pregnancy, history of neoadjuvant treatment, advanced or metastatic oncological diseases, with systemic diseases unsuitable for surgical interventions and other contradictions of conventional laparoscopic surgery.

The study was conducted according to the protocol approved by the ethics committee of the hospital (KF-600-3-705) in accordance with the World Medical Association’s Declaration of Helsinki 2013, and was registered at https://clinicaltrials.gov/. This work has been reported in line with the strengthening the reporting of cohort, cross-sectional and case–control studies in surgery (STROCSS) criteria³⁰ (Supplemental Digital Content 1, http://links.lww.com/JS9/A801). All procedures were completed at a tertiary general surgery center by a skilled surgical team who possesses experiences of over five hundred cases of SILS gastrointestinal surgery and over seven hundred cases of robotic general surgery. The medical and hospitalization costs of all the seven enrolled SIRAS patients were covered by research fundings.

Data collection

The demographic, perioperative, and clinicopathologic outcomes of the SIRAS group were recorded and shown in Table 1, Table 2, and Table 3, respectively. The demographic data included age, sex, BMI, ASA class, diagnosis, preoperative staging by computed tomography, history of systemic disease, history of previous abdominal surgery, history of smoking and alcohol, history of neoadjuvant treatment, hemoglobin level, and albumin level. The perioperative outcomes included operation, total operative time, robot preparing and port placing time, docking time, console time, estimated blood loss (EBL), intraoperative and postoperative complications, conversion, incision site, length of skin incision, first flatus day, time to liquid diet, length of stay (LOS), short-term mortality, postoperative recurrence, incisional hernia and follow-up. The clinicopathologic outcomes included pathological diagnosis, staging, lymph nodes harvested, lymph nodes positive of tumor metastasis, extramural vascular invasion, nerve invasion, circumferential resection margin, proximal resection margin, distal resection margin, intactness of mesocolon or mesorectum, distance from tumor to proximal margin, distance from tumor to distal margin, specimen length, and the maximum diameter of the tumor. Especially, the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life (QoL) questionnaires (QLQ) QLQ-C30 (version 3.0)³¹ were conducted on all seven enrolled SIRAS patients at the point of 4 months after the surgery. QoL domains range from 0 to 100, where a higher score reflects a more complete function in terms of functional scores, and a higher score reflects a heavier symptom burden in terms of symptom domains. The QoL outcomes were recorded and shown in Table 4.

Table 1.

The demographic data of enrolled SIRAS patients.

Case	Age	Sex	BMI(kg/m2)	ASA	Diagnosis	Preoperative CT staging	History of systemic disease	History of previous abdominal surgery	History of smoking and alcohol	History of neoadjuvant treatment	HB Level(g/l)	ALB Level(g/l)
Patient No.1	62	Male	27.22	1	Sigmoid colonic adenocarcinoma	cT3N0M0	Hypertension	Denied	Denied	Denied	99	37
Patient No.2	44	Male	23.94	1	Sigmoid colonic adenocarcinoma	cT1N0M0	Denied	Denied	Admitted	Denied	150	39
Patient No.3	69	Male	20.25	2	Rectosigmoid colonic adenocarcinoma	cT3N0M0	Hypertension, cerebral infarction	Denied	Denied	Denied	120	38
Patient No.4	67	Male	25.16	1	Rectal adenocarcinoma	cT1N0M0	Denied	Denied	Denied	Denied	136	42
Patient No.5	59	Male	24.09	2	Hepatic flexure colonic adenocarcinoma	cT3N0M0	Coronary heart disease	Denied	Denied	Denied	88	37
Patient No.6	54	Male	29.2	2	Ascending colonic adenocarcinoma	cT3N0M0	Hypertension	Denied	Admitted	Denied	137	42
Patient No.7	69	Female	22.67	1	Rectal adenocarcinoma	cT2N0M0	Denied	Admitted	Denied	Denied	118	36

ASA, American Society of Anesthesiologists; SIRAS, single-incision robotic assisted surgery.

Table 2.

The perioperative outcomes of enrolled SIRAS patients.

Case	Operation	Distance of lesion to anus (cm)	Operation radical degree	Total operative time (min)	Robot preparing and port placing time (min)	Docking time (min)	Console time (min)	EBL (ml)	Intraoperative complications	Conversion	Incision site	Length of skin incision (cm)	Postoperative complications (Clavien–Dindo Grade)	First flatus (POD)	Time to liquid diet (POD)	LOS (d)	Short-term mortality	Postoperative recurrence	Incisional hernia	Follow-up
Patient No.1	Sigmoid colectomy (CME)	22	R0	172	20	10	135	10	None	None	Right rectus abdominis	4	None	2	4	7	None	None	None	On going
Patient No.2	Sigmoid colectomy (CME)	28	R0	196	14	8	124	30	Injury of LCIA adventitia	None	Right rectus abdominis	4	None	3	4	7	None	None	None	On going
Patient No.3	Low anterior resection (TME)	15	R0	148	25	15	93	25	None	None	Right para-umbilical	3.5	None	2	3	7	None	None	None	On going
Patient No.4	Low anterior resection (TME)	7	R0	348	22	13	312	10	None	Laparoscopic surgery	Right rectus abdominis	4	None	3	4	7	None	None	None	On going
Patient No.5	Right hemicolectomy (CME)	/	R0	242	25	14	154	150	Hemorrhage	None	Right para-umbilical	4	None	3	4	7	None	None	None	On going
Patient No.6	Right hemicolectomy (CME)	/	R0	368	22	10	293	1200	Hemorrhage	Laparoscopic surgery	Right para-umbilical	4	None	4	5	8	None	None	None	On going
Patient No.7	Low anterior resection (TME)	12	R0	184	21	13	107	18	None	None	Right rectus abdominis	4	None	3	4	10	None	None	Occurred	On going

EBL, estimated blood loss; CME, complete mesocolic excision; LCIA, left common iliac artery; LOS, length of stay; SIRAS, single-incision robotic assisted surgery; TME, total mesorectal excision.

Table 3.

The clinicopathologic outcomes of enrolled SIRAS patients.

Case	Pathological diagnosis	Staging	Lymph nodes positive	Lymph nodes harvested	EMVI	Nerve invasion	Circumferential resection margin	Proximal resection margin	Distal resection margin	Intactness of mesocolon/mesorectum	Distance to proximal resection margin (cm)	Distance to distal resection margin (cm)	Specimen length (cm)	Maximum diameter of tumor (cm)
Patient No.1	Colon adenocarcinoma	pT3N1bM0	3	12	Positive	Negative	Negative	Negative	Negative	Complete	3	8	14	3.5
Patient No.2	Colon adenocarcinoma	pT1N0M0	0	14	Negative	Negative	Negative	Negative	Negative	Complete	5	5	16	3
Patient No.3	Rectal adenocarcinoma	pT4aN1aM0	1	7	Positive	Positive	Negative	Negative	Negative	Complete	6	2	12	3
Patient No.4	Rectal adenocarcinoma	pT1N0M0	0	4	Negative	Negative	Negative	Negative	Negative	Complete	13	2	16	2.2
Patient No.5	Colon adenocarcinoma	pT4aN0M0	0	20	Positive	Positive	Negative	Negative	Negative	Complete	13.8	9	20	3
Patient No.6	Colon adenocarcinoma	pT4aN1bM0	3	11	Positive	Negative	Negative	Negative	Negative	Complete	15	5	24	6
Patient No.7	Rectal adenocarcinoma	pT1N1aM0	1	13	Positive	Negative	Negative	Negative	Negative	Complete	2.5	2.5	6	1.2

EMVI, extramural vascular invasion; SIRAS, single-incision robotic assisted surgery.

Table 4.

The QOL data of enrolled SIRAS patients.

	Patient No.1	Patient No.2	Patient No.3	Patient No.4	Patient No.5	Patient No.6	Patient No.7	Mean(±SD)
Physical function	86.67	100	66.67	86.67	80	80	80	82.86±10.08
Role function	83.33	66.67	66.67	66.67	66.67	50	66.67	66.67±9.62
Emotion function	83.33	91.67	83.33	83.33	91.67	91.67	66.67	84.52±8.91
Cognitive function	100	100	100	100	100	83.33	83.33	95.24±8.13
Social function	83.33	66.67	50	50	66.67	66.67	66.67	64.29±11.50
Quality-of-life	66.67	75	75	75	83.33	66.67	66.67	72.62±6.30
Fatigue	33.33	33.33	33.33	33.33	33.33	33.33	33.33	33.33
Nausea and vomitting	0	0	0	0	0	0	0	0
Pain	16.67	0	16.67	0	0	0	16.67	7.14±8.91
Dyspnea	0	0	0	33.33	33.33	33.33	0	14.28±17.82
Sleepless	0	0	33.33	33.33	33.33	33.33	33.33	23.81±16.26
Appetite loss	0	0	33.33	33.33	0	0	0	9.52±16.26
Constipation	0	0	0	0	0	0	0	0
Diarrhea	33.33	0	0	0	0	0	0	4.76±12.60
Financial difficulty	0	0	33.33	33.33	33.33	33.33	0	19.05±17.82

QoL, quality-of-life; SIRAS, single-incision robotic assisted surgery.

The demographic, perioperative, and clinicopathologic outcomes of the RAS group were recorded and shown in Supplement Table 1 (Supplemental Digital Content 2, http://links.lww.com/JS9/A802), Supplement Table 2 (Supplemental Digital Content 3, http://links.lww.com/JS9/A803), and Supplement Table 3 (Supplemental Digital Content 4, http://links.lww.com/JS9/A804), respectively. And those of SILS group were recorded and shown in Supplement Table 4 (Supplemental Digital Content 5, http://links.lww.com/JS9/A805), Supplement Table 5 (Supplemental Digital Content 6, http://links.lww.com/JS9/A806), and Supplement Table 6 (Supplemental Digital Content 7, http://links.lww.com/JS9/A807), respectively. The demographic data included age, sex, BMI, ASA class, diagnosis, preoperative staging by computed tomography, history of systemic disease, history of previous abdominal surgery, history of smoking and alcohol, history of neoadjuvant treatment, hemoglobin level, and albumin level. The perioperative outcomes included operation, total operative time, EBL, intraoperative and postoperative complications, conversion, first flatus day, time to liquid diet, LOS, short-term mortality, postoperative recurrence, and incisional hernia. The clinicopathologic outcomes included pathological diagnosis, staging, lymph nodes harvested, lymph nodes positive of tumor metastasis, extramural vascular invasion, nerve invasion, circumferential resection margin, proximal resection margin, distal resection margin, intactness of mesocolon or mesorectum, distance from tumor to proximal margin, distance from tumor to distal margin, specimen length, and the maximum diameter of the tumor.

Technological feasibility was assessed with the criteria that SIRAS colorectal surgery was performed with no conversion, or no major and eventful intraoperative complication, which referred to no cardiopulmonary complications, no injury of peripheral organs, no unexpected resection of adjacent organs, no unexpected tumor rupture, and intraoperative hemorrhage below 200 ml. Perioperative outcomes (total operative time, robot preparing and port placing time, docking time, console time, EBL, intraoperative and postoperative complications, length of skin incision, LOS, short-term mortality, postoperative recurrence, and incisional hernia), clinicopathologic outcomes (quality of complete mesocolic excision (CME) or total mesorectum excision (TME), tumor size, number of lymph nodes harvested, and distal margin) and follow-up were recorded and reported. The intraoperative complications referred to intraoperative hemorrhage, injury of peripheral organs, tumor contamination of the incision or surgical field, and intestinal content contamination of the incision or surgical field. Graded by Clavien–Dindo classification, the postoperative complications were observed within 30 days after surgery, including intra-abdominal hemorrhage, stomal leak, respiratory tract infection, incision infection, intra-abdominal infection, deep venous thrombosis, and intestinal obstruction. The clinicopathologic outcomes were evaluated by at least two pathologists. Follow-up surveillance was conducted in accordance with National Comprehensive Cancer Network (NCCN) guidelines^32,33. Postoperative recurrence was evaluated by radiological and histological methods. Patients with high-risk stage II or stage III disease were sent to postoperative chemotherapy. For those who presented as metastasis or recurrence, a standard evaluation according to the NCCN guidelines^32,33 would be conducted for further treatment.

Surgical details

SIRAS sigmoid colectomy/low anterior resection

After general anesthesia and bladder catheterization, the patient was placed in a lithotomy position and further prepped and draped in sterility. The customized single-incision port (Beijing Surgerii Technology Co., Ltd.) was installed through a 4 cm single-incision through the right rectus abdominis at the umbilical level or right para-umbilical site (Fig. 2A, C). Then the abdomen was insufflated with CO₂ and the pneumoperitoneum was established with a pressure setting of 15 mmHg. After the insertion of the robotic endoscopic tool, preliminary abdominal exploration was performed for tumor location, tumor size, lymph node metastasis and cancer nodule, as well as other abdominal organs, and the docking of the robot (SR-ENS-600, Beijing Surgerii Technology Co., Ltd.) was introduced from the left side with the patient-side cart of the platform positioned at an angle to the operating table. The 3D robotic endoscopic tool was placed above the other three robotic arms (Supplement Video 1, Supplemental Digital Content 8, and Figs 3, 4). The assistant stood on the right side of the patient and awaited further instructions.

Figure 2.

The port setting of SIRAS. (A) SIRAS sigmoid colectomy / low anterior resection. (B) SIRAS right hemicolectomy. (C) SIRAS low anterior resection in case NO.3. SIRAS, single-incision robotic assisted surgery.

Figure 3.

The robotic instruments of SR-ENS-600 platform. (A) Robotic endoscopic tool. (B) Robotic surgical tool. (C) The dual continuum mechanism used in the instruments.

Figure 4.

The overview of single-incision robotic assisted surgery radical sigmoid colectomy. (A) Creation of the 4 cm single-incision through the right rectus abdominis. (B) Establishment of the pneumoperitoneum. (C) General view of surgeon console. (D) General view of robotic surgery.

The medial-to-lateral approach and D3 lymph node dissection were adopted according to the principles of CME and TME. The patient was tilted with the left side elevated 30° up in Trendelenburg position to acquire better visualization of sigmoid colon. First, the sigmoid mesentery was incised at the intersection of the projection of Toldt’s line and the level of sacral isthmus, to enter the Toldt’s fascia and expand the holy plane using the bipolar robotic dissecting forceps and the unipolar robotic scissors (Supplement Video 2, Supplemental Digital Content 9). The superior mesenteric nerve plexus, left ureter, and left genital vessels were identified and protected. The lymph nodes around the root of inferior mesenteric artery (IMA) were dissected, and ligation of the IMA was performed by assistant using Hem-o-lok (Teleflex Inc., WECK Co.) through the assistant channel in the single-incision port. After the ligation of the IMA, the inferior mesenteric venous was dissected and ligated at the level of the duodenojejunal peritoneal fold. And then, the rectosacral fascia was incised and the presacral space was expanded downward, in addition the bilateral peritoneum was dissected to fully expand the peri-mesorectal space (Supplement Video 2, Supplemental Digital Content 9). The distal resection margin was defined as 5 cm below the tumor, at which level the mesorectum was dissected to acquire bare bowel. An additional preplanned 12 mm trocar was inserted in the right inferior quadrant of the abdomen for endo-stapler and drainage. The colon was separated from the rectum by an assistant using the Endo GIA Ultra Universal Stapler (Medtronic Inc.) with Tri-Staple 60 mm Purple Reload (Medtronic Inc.). Furthermore, the dissection of mesentery was performed in a distal-to-proximal fashion following the Toldt’s line to achieve a mobilized descend colon. Mobilization of the splenic flexure was not performed.

The robot was undocked at this point. The proximal bowel was pulled out through the right rectus abdominis incision and the specimen was removed by an 80 mm linear cutter (Covidien Co.). A 2-0 purse string suture was performed at the distal end of the descend colon and EEA 28 mm Single-Use Stapler Anvil (Covidien Co.) was tied in. The perfusion of the distal bowel was checked. After the pneumoperitoneum was re-established, the remaining surgery was performed laparoscopically by a robotic endoscopic tool. The EEA 28 mm Single-Use Stapler (Covidien Co.) was oiled and inserted to proximal rectum. An end-to-end anastomosis was performed totally intracorporeally with the help of a laparoscopic grasper inserted through the additional trocar. After flushing and inspecting the peritoneal cavity to ensure there was no macroscopic bleeding, a drainage tube was placed in front of the sacral area with the other end of it extracted through the preplanned additional trocar. The robotic camera and laparoscopic instruments were withdrawn and the wound protector was removed. The abdominal fascia was closed with 1-0 PDS and the incision was closed with 1 Vicryl Plus (Ethicon Co.) on subcutis and 4-0 Monocryl (Ethicon Co.) intradermally.

SIRAS right hemicolectomy

After general anesthesia and bladder catheterization, the patient was placed in horizontal position with legs split and further prepped and draped in sterility. The single-incision port was installed through a 4 cm single-incision through the right para-umbilical site (Fig. 2B). Then the pneumoperitoneum was established with a pressure setting of 15 mmHg. After the abdominal exploration was performed, the docking of the robot was introduced from the right side with the patient-side cart of the platform positioned at an angle to the operating table. The 3D robotic endoscopic tool was placed above the other three robotic arms. The assistant stood on the left side of the patient and awaited further instructions.

The medial-to-lateral approach and D3 lymph node dissection were adopted according to the principle of CME. After dragging the small intestine to the left abdominal cavity, the ileocolic mesentery was lifted and incised, and the mesentery was dissected along the ileocolic vessels from the distal to the proximal to reach the superior mesenteric vessels. Then, the right retro-colic space was expanded laterally to the surface of the duodenum, and the prepancreatic capsule was exposed. Dissection continued upward along the superior mesenteric vessels. The lymph nodes around the root of the superior mesenteric artery (SMA) were dissected. The ileocolic artery, right colic artery, and middle colic artery were identified, and ligated by Hem-o-lok. Dissection continued along the surface of the superior mesenteric vein to identify the Helen’s trunk. Ileocolic vein, right colic vein, right gastroomental vein, and the superficial branches of inferior pancreaticoduodenal vein were identified, and ligated by Hem-o-lok distal to the Helen’s trunk. No.6 lymph nodes were dissected. The gastrocolic ligament was incised, and the mesentery was dissected from the inferior margin of the pancreas downward to the Toldt’s fascia and finally connect to the inferior space. The right nephron-colic ligament was incised and the right Toldt’s line was dissected to loosen the ileocecal junction and terminal ileum. The transverse mesocolon was dissected to loosen the right half of the transverse colon, and the right half of the omentum majus was dissected.

The robot was undocked at this point. The target bowel was pulled out through the right para-umbilical incision. Transverse mesocolon and meso-ileum were incised, and dissected to acquire bare bowel at the transverse colon and ileum 15 cm from the ileocecal junction, meanwhile colic marginal artery was protected. The specimen was removed by scalpel. Side-to-side ileum-colon anastomosis was performed by an 80 mm linear cutter. The common stoma of the ileum and transverse colon was closed by an 80 mm linear cutter. The anastomosis was reinforced by running suture and interrupted suture with 4-0 Vicryl. The bowel was placed back into the abdominal cavity and the physiological anatomy was restored. After the pneumoperitoneum was re-established, the remaining surgery was performed laparoscopically by a robotic endoscopic tool. After flushing and inspecting the peritoneal cavity to ensure there was no macroscopic bleeding, a drainage tube was placed in the right paracolic sulci, next to the ileocolic anastomosis. The other end of the drainage was dragged out through a new incision at the right lower quadrant of the abdomen. The robotic camera and laparoscopic instruments were withdrawn and the wound protector was removed. The abdominal fascia was closed with 1-0 PDS and the incision was closed with 1 Vicryl Plus on the subcutis and 4-0 Monocryl intradermally.

Statistics analysis

Prism version 9.5.0 (GraphPad, California) and SPSS version 26.0 (IBM) were applied for statistical analysis. Student’s t-test, Mann–Whitney U test, ordinary one way ANOVA test, and Brown–Forsythe and Welch ANOVA tests were applied to calculate the differences between groups. Pearson’s χ ² and Fisher’s exact tests were applied to assess categorical variables. The results were showed as median and mean±SD. Results were considered statistically significant at P values <0.05 and FDR <0.05.

Result

Patients

The seven enrolled SIRAS patients had a mean (±SD) age of 60.60±9.18 years (range from 44 to 69) and had a mean (±SD) BMI of 24.65±2.93 kg/m² (range from 20.25 to 29.20). Most of the patients were male (86%) and all patients were classified to ASA grade I or II. Four patients (57%) had admitted a history of systemic diseases, one patient (14%) had admitted a history of previous abdominal surgery, and one patient (14%) had admitted a history of alcohol or smoking. All patients had denied a history of neoadjuvant treatment on tumor. The demographic data of these seven cases were shown in Table 1.

Patients of RAS group (Supplement Table 1, Supplemental Digital Content 2, http://links.lww.com/JS9/A802) and SILS group (Supplement Table 4, Supplemental Digital Content 5, http://links.lww.com/JS9/A805) exhibited the comparable demographic characteristics, where statistics analysis did not show significant differences (Table 5).

Table 5.

The comparable demographic data of enrolled patients from SIRAS, RAS, and SILS group.

	Numbers of patients
Characteristics	SIRAS group	RAS group	P	SILS group	P
	7	23			35
Age (years)
>65	3	8	0.9524	12	1.0000
<=65	4	15		23
Sex
Male	6	14	0.4454	21	0.3875
Female	1	9		14
ASA
>2	0	0	/	4	0.8142
<=2	7	23		31
BMI (kg/m2)
>25	3	7	0.8787	9	0.6468
<=25	4	16		26
Tumor location
Right hemicolon	2	10	0.7915	8	0.8713
Sigmoid colon, rectalsigmoid colon, and rectus	5	13		27
History of systemic disease
Admitted	4	12	0.8400	24	0.8836
Denied	3	11		11
History of abdominal surgery
Admitted	1	8	0.5720	10	0.7536
Denied	6	15		25
History of smoking or alcohol
Admitted	2	5	0.8918	8	0.8713
Denied	5	18		27
History of neoadjuvant treatment
Admitted	0	0	/	0	/
Denied	7	23		35
Preoperative CT staging
>IIIA	0	7	0.2474	10	0.2567
<=IIIA	7	16		25
HB level (g/l)
>=120	4	16	0.8787	30	0.2186
<120	3	7		5
ALB level (g/l)
>=35	7	21	0.9540	30	0.6700
<35	0	2		5

EBL, estimated blood loss; LOS, length of stay; POD, postoperative day; RAS, robotic assisted surgery; SIRAS, single-incision robotic assisted surgery; SILS, single-incision laparoscopic surgery.

Operations, perioperative outcomes, and postoperative outcomes

As the initial experiences in performing SIRAS using the novel SR-ENS-600 platform, we reported the first seven cases of colorectal adenocarcinoma who underwent surgery from March to September, 2022.

SIRAS operations were completed safely without major and eventful intraoperative complications except a 1200 ml of hemorrhage was happened in case No.6. And the operations were performed feasibly except conversions to multiport laparoscopic surgery were occurred in case No.4 and case No.6. Although there were obstacles in the initial attempts of SIRAS colorectal surgery, all seven patients of SIRAS group recovered well and presented with satisfying postoperative outcomes. However, there were intraoperative complications needed to be pointed out that the adventitia of the left common iliac artery (LCIA) in patient No.2 was injured and intraoperative hemorrhage was occurred in patient No.5 and patient No.6. In details, the adventitia of LCIA was injured while dissecting the lymph nodes around the root of IMA in patient No.2. Subsequently the adventitia was sutured by 4-0 PROLENE (Ethicon Co.) intracorporeally total in the console (Supplement Video 3, Supplemental Digital Content 10), and the patient recovered well and there was no further complication reported. In patient No.5 and patient No.6, intraoperative hemorrhages were occurred while dissecting the lymphoid and mesentery fat tissues around the SMA, which caused 150 ml EBL in patient No.5, and caused 1200 ml EBL in patient No.6, which led to the unexpected conversion to multiport laparoscopic surgery. Ultrasonic coagulation was performed and intraoperative blood transfusion was adopted as support care. There was another conversion took place in low anterior resection for patient No.4. After entering the presacral space, the deep and narrow pelvis cavity joined the plump mesorectum to raise an impenetrable obstacle for fine anatomy. The coaxality coming from the single-incision port and the restricted surgical triangle relative to the bucky mesorectum limited the robotic multitask ability of retraction, visualization, and dissection while encountering the hypertrophic mesorectum and the stenotic, tunnel-like pelvis cavity. The remaining operation was converted to multiport laparoscopic surgery. There was no conversion to traditional open surgery. In terms of the perioperative outcomes of different surgical approaches, there were three cases of intraoperative hemorrhage, one case of spleen injury, and four conversions to multiport laparoscopic surgery and one conversion to traditional open surgery reported in the SILS group (Supplement Table 5, Supplemental Digital Content 6, http://links.lww.com/JS9/A806). Statistics analysis suggested a higher rate of intraoperative complications in the SIRAS group than that of the RAS group, but no significant difference was discovered between the SIRAS group and the SILS group (Table 6).

Table 6.

The comparable perioperative outcomes of enrolled patients from SIRAS, RAS, and SILS group.

	SIRAS group		RAS group			SILS group
Characteristics	Median	Mean (±SD)	Median	Mean (±SD)	P	Median	Mean (±SD)	P
Total operative time (min)	196	236.86±87.70	231	236.39±53.39	>0.9999	129	138.54±34.89	0.0702
EBL (ml)	25	206.14±441.04	120	119.78±31.24	0.9348	90	120.43±125.63	0.9373
First flatus (POD)	3	2.86±0.69	3	2.83±0.78	0.9934	2	2.51±0.56	0.4247
Time to liquid diet (POD)	4	4±0.58	4	3.83±0.78	0.8085	4	3.54±0.56	0.2113
LOS (d)	7	7.57±1.13	10	10.40±2.98	0.0241*	9	9.20±2.25	0.2535
/	Numbers		Numbers		P	Numbers		P
Conversion
Occurred	2		0		0.0737	5		0.7111
None	5		23			30
Intraoperative complications
Occurred	3		0		0.0096*	4		0.1385
None	4		23			31

LOS, length of stay; POD, postoperative day; RAS, robotic assisted surgery; SIRAS, single-incision robotic assisted surgery; SILS, single-incision laparoscopic surgery.

All seven SIRAS operations achieved degree R0 resection. Operative times varied with different operations. The mean (±SD) operation time of SIRAS sigmoid colectomy was 184.0±16.97 mins (range from 172 to 196). And that of SIRAS low anterior resection and SIRAS right hemicolectomy were 226.7±106.61 mins (range from 148 to 348) and 305.0±89.10 mins (range from 242 to 368), respectively (Table 2). Considering its first-attempt and in-learning-curve feature, the operative time of SIRAS was compatible (Table 6) with that of the RAS group (Supplement Table 2 , Supplemental Digital Content 3, http://links.lww.com/JS9/A803) and SILS group (Supplement Table 5, Supplemental Digital Content 6, http://links.lww.com/JS9/A806).

There was no short-term postoperative complication reported in the SIRAS group. The SIRAS patients presented the first flatus on a mean (±SD) POD of 2.86±0.69 (range from 2 to 4), had a mean (±SD) time to liquid diet on POD 4.00±0.58 (range from 3 to 5), and presented a mean (±SD) LOS of 7.57±1.13 (range from 7 to 10) (Table 2), which seemed to presented a little shorter LOS than that of RAS group (Table 6), especially considering the circumstance of coronavirus disease 2019 (COVID-19) pandemic in Shanghai in which two negative COVID-19 nucleic acid test within 3 days was mandatory for discharge. In addition, there were no short-term mortality, or postoperative recurrence reported in SIRAS group. At the time that half a year after operation, there was one SIRAS case (patient No.7) of incisional hernia reported. The perioperative outcomes of all seven SIRAS cases were shown in Table 2. In terms of the postoperative outcomes of different surgical approaches, there were two cases of respiratory tract infection (Clavien–Dindo level II, II) reported in RAS group, two cases of intra-abdominal infection (II) and one case of incision infection (II) reported in SILS group, four cases from RAS group and another four cases from SILS group reported recurrence, and three cases of incisional hernia reported in SILS group (Supplement Table 2, Supplemental Digital Content 3, http://links.lww.com/JS9/A803 and Supplement Table 5, Supplemental Digital Content 6, http://links.lww.com/JS9/A806). Statistics analysis did not show significant differences of postoperative outcomes between the SIRAS group, the RAS group, and the SILS group (Table 7).

Table 7.

The comparable postoperative outcomes of enrolled patients from SIRAS, RAS, and SILS group.

	SIRAS group	RAS group		SILS group
Characteristics	Numbers	Numbers	P	Numbers	P
Postoperative complications
Occurred	0	2	0.9540	3	0.9999
None	7	21		32
Short-term mortality
Occurred	0	0	/	0	/
None	7	23		35
Postoperative recurrence
Occurred	0	4	0.5821	4	0.8142
None	7	19		31
Incisional hernia
Occurred	1	0	0.5214	3	0.8142
None	6	23		32

RAS, robotic assisted surgery; SIRAS, single-incision robotic assisted surgery; SILS, single-incision laparoscopic surgery.

Clinicopathological outcomes

The complete CME or TME resections in all seven SIRAS cases were verified by at least two pathologists with a complete, intact mesocolon or mesorectum, as well as a negative resection margin. Postoperative pathological report showed advanced lymphoid staging of patient No.1, No.3, No.6 and No.7, as well as other high-risk factors shown in Table 3. Patients with advanced staging were sent to standard evaluation and postoperative chemotherapy according to the NCCN guidelines^32,33. Follow-up surveillance is still on going for all included SIRAS patients. Especially, the distance of the tumor to the proximal resection margin in patient No.7 of the SIRAS group was 2.5 cm. In addition, this patient went through a preoperative endoscopic submucosal dissection on her rectal mass and was diagnosed with rectal high-grade intraepithelial neoplasia. The SIRAS low anterior resection was performed with adequate resection margins to balance surgical benefits and excision extension. The clinicopathological outcomes of the RAS group and the SILS group were shown in Supplement Table 3 (Supplemental Digital Content 4, http://links.lww.com/JS9/A804) and Supplement Table 6 (Supplemental Digital Content 7, http://links.lww.com/JS9/A807), respectively.

QoL and follow-up

EORTC QoL QLQ-C30 were completed in all seven SIRAS patients at the point of 4 months after the surgery. The QoL outcomes were shown in Table 4. According to the current studies^34,35, the QoL outcomes of SIRAS patients based on the novel surgical platform were compatible with that of conventional multiport laparoscopic surgery, SILS, RAS, and trans anal TME.

Discussion

After being first advocated by Heald in 1982³⁶, intact and precise CME and TME resection play as a fenderguard role in surgeons’ endless pursuit for minimizing the invasiveness of surgical interventions without any concession on oncologic safety. When surgical technique development of minimally invasive surgery shed lights on SILS, complex technological obstacles such as triangulation loss, instrument collision and poor exposure especially in narrow anatomy, counteract the passion raised by the advantages of improved cosmesis, less pain and faster recovery^13–17. The introduction of a robotic surgical platform for SILS was reported to be beneficial of enhanced instrument maneuverability and stability, as well as precise operation. Since then, studies on the safety, feasibility, and effectiveness of SIRAS in general surgery have been springing up in the literature^18–29.

As the priority of performing a newly-developing procedure, the feasibility and safety of SIRAS have been demonstrated, on the basis of a novel robotic surgical platform, the SR-ENS-600 platform. Although in patient No.2, there was an unexpected injury of the adventitia of LCIA while dissecting the lymph nodes around the root of IMA. The subsequent intracorporeal suturing of the adventitia, was performed completely in console (Supplement Video 3, Supplemental Digital Content 10) that the dual continuum configuration of the snake-like robotic arms of the SR-ENS-600 platform helped to reconstruct the surgical triangle above the injured adventitia and restricted its elaborate operation within the limited surgical field, and exhibited excellent dexterity and operative precision offered by the SR-ENS-600 platform, which is essential for handling emergency. In addition, there was no short-term postoperative complications and mortality reported (Table 2). In all seven SIRAS cases, ensured by intact mesocolon and mesorectum, complete CME or TME resections (Table 3) were performed successfully through a single abdominal incision without sacrifice of oncologic safety. In addition, the LOS of the SIRAS group seemed to be shorter than that of the RAS group (Table 6). However, the rate of intraoperative complication in SIRAS group was significantly higher than that of RAS group, although there was no significant difference of intraoperative complications between the SIRAS group and the SILS group (Table 6). In details, the complex intra-abdominal anatomies in several SIRAS patients and the relative weaker retraction compared to the multiport-design Da vinci Xi platform raised difficulties in the initial attempts of SIRAS colorectal procedures. Considering the rigorous technical demands of this novel surgical approach, and the steep learning curve of the SIRAS procedures, the short-term outcomes of the SIRAS group were comparable and promising.

Labeled as one main technical difficulty in coloproctology oncological surgery, multisite anatomy is required for dissecting mesocolon and mesenteric vessels in inferior abdomen, mesorectum in pelvic cavity, as well as left superior quadrant of abdomen in cases of mobilizing splenic flexure. To surmount this obstacle, extensive exposure and organ retraction, restoring instrument triangulation, as well as sufficient payload capacity of robotic arms are necessary, which usually required several additional ports^24,26 installed or redocking the robot²⁵ while performing the procedures by the Da Vinci Si, Xi platform. In terms of the novel surgical platform, each separate snake-like robotic arm of the SR-ENS-600 platform was constructed on so-called dual continuum configuration (Fig. 3C) rather than jointed design, with effective payload capacity of 10 Newton, which possesses 6 degrees of freedom with each joint can bent 90° (Supplement Video 1, Supplemental Digital Content 8). Based on this reliable configuration design, multisite anatomy was successfully performed in our initial experiences of SIRAS colorectal oncological surgeries without redocking the robot and re-placing the unexpected additional port. As shown in Supplement Video 2, Supplemental Digital Content 9, surgeon can easily control the potent snake-like forceps for fine anatomy, switch them and relocate the robot for multisite dissection in console, where the brief sketch of three robotic arms and laparoscope camera was monitored real-time. Differed from the unity-design robotic arms of the Da Vinci SP platform, the separate-design robotic arms make the SR-ENS-600 platform also compatible for multiport surgery. What is more, the handholdable robotic endoscopic tool for laparoscopic surgery saved us an unexpected extra docking time for intracorporeal anastomosis after pneumoperitoneum reestablishment that was required in left hemicolectomy and low anterior resection via Da Vinci SP platform^25,27,29. All these advantages of SR-ENS-600 platform contributed to the encouraging perioperative outcomes of our initial experiences on SIRAS colorectal oncological surgeries. Compared with current literature^18,25–29, our initial experiences reported an even shorter total operative time and less EBL, indicating comparable and promising short-term outcomes. In terms of the specific strengths and deficiencies of SIRAS approach, while compared with SILS approach, the preferable instrument maneuverability and stability, magnified and clarified visualization, and broader exact-on-site triangle reconstruction provided by the novel surgical platform help to handle more sophisticated procedures; however, SIRAS approach has more stringent demands of equipment accessibilities, surgical technologies and experiences, and costs lots of economical burdens in current situation, and lack of built-in ultrasonic energy device still raises difficulty in no-bleeding anatomy. In contrast to RAS approach, multisite dissection through once docking, less incision and shorter incision length, enhanced fast recovery were labeled as the strengths of SIRAS approach, meanwhile the separate-design robotic arms of the novel surgical platform were also compatible for multiport RAS and laparoscopic approaches, whereas the relative weaker payload capacity compared to that of Da vinci Xi platform, and the coaxial effect of single-incision port, which raised difficulties in retraction and exposure in certain deep and narrow pelvis, still limit the generalized applications of SIRAS approach.

However, there are still several evident drawbacks that need to be pointed out. Similar to the Da Vinci SP platform^{20,23,25,27,29}, lack of build-in vessel sealing device, ultrasonic dissection device, suction device, and customized stapler raises another difficulty in paving the road for further application of SIRAS. In our experiences, assistant could use Hem-o-lok though the assistant trocar in the customized port for ligation. In terms of SIRAS sigmoid colectomy and SIRAS low anterior resection, whereas encountering bowel excision, the coaxial effect hinders the endo-stapler for further dissection and anastomosis, which require a preplanned additional 12 mm trocar in the right inferior quadrant of the abdomen, as the same drawback that was also reported in low anterior resection via Da Vinci Xi or SP platform^24,29. In addition, build-in ultrasonic energy device is also expected in a future update. In our experiences, ultrasonic coagulation plays an important role in no-bleeding anatomy of colorectal oncological surgeries, especially encountering intraoperative hemorrhage while dissecting around IMA, SMA, the Helens trunk, or the right gastroepiploic vessels, where the same situations we encountered in patient No.5 and patient No.6 that unexpected tissue adhesions, enlarged lymphoid nodes, and the distorted branches of veins did hinder the ideal resection and raised the risk of hemorrhage. In patient No.6, a 1200 ml of intraoperative hemorrhage led to a much longer operative time and the conversion to multiport laparoscopic surgery. In addition, while dissecting the bulky mesorectum in deep and narrow pelvis cavity of patient No.4, the coaxial effect coming from the customized single-incision port holds the exquisite snake-like robotic arm back. Although the surgical triangle reconstruction by the snake-like robotic arms partially compensated this coaxial effect, the hypertrophic mesorectum raised the difficulties of retraction and exposure for the target surgical field on peri-mesorectum space via its relatively limited operation space provided by this novel surgical platform. Under this circumstance, concerns were raised and the indications and contradictions of SIRAS low anterior resection were further refined. According to our experiences, tumor below the retroperitoneal reflection, tumor maximum diameter greater than 3 cm, BMI greater than 25, preoperatively confirmed narrow pelvis cavity by MRI or CT, and history of previous abdominal surgery were contradictions of SIRAS low anterior resection. In terms of the indications of SIRAS, considering its steep learning curve, tumor maximum diameter less than 3 cm, BMI less than 25, no history of previous abdominal surgery and neoadjuvant treatment were proposed. In addition, sigmoid colectomy was suggested to be adopted as the first attempt of SIRAS. Compared with the short-term outcomes from the initial in-learning-curve attempts of the RAS group and the SILS group, the perioperative outcomes and postoperative outcomes of the SIRAS group exhibited its comparability and a promising value for further investigation. For further widespread application, especially in technical demanding surgery, these technological obstacles mentioned above should be remedied. Although our initial experience was encouraging and comparable, there are indeed demands for further validation and exploration from large-scale prospective studies or multicenter randomized controlled trials.

This study has several limitations. First, the enrolled population of the SIRAS group was biased because it was almost male, where the potential technological challenges may come from the different physiological construction of the female pelvis cavity. In addition, the enrolled population of the SIRAS group was totally ASA class I–II and was below or equal to AJCC stage IIIA, while almost one-third population of the RAS group and the SILS group had a tumor stage advanced to IIIA, and the SILS group had patients with ASA class III, although the differences did not reach statistical significance. These population biases limited the further generalization of the study results. Second, the population of the SIRAS group was relatively small, where the outcomes reflected the expected steep learning curve rather than obtained the exact plateau of its learning curve and further concluded the noninferiority of the novel surgical platform. Third, there were three different procedures that were investigated within the certainly limited case load, which further restricted the study’s conclusions. Fourth, although the data of each group were labeled as the first in-learning-curve attempts from the same surgical team, these comparable data did not come from the same time period, considering that the experiences of one surgical approach may compensate for another, where data from the novel platform may take this potential advantages. A randomized, large-volume, prospective controlled study is preferred for further investigation.

Conclusion

Single-incision robotic assisted colorectal procedures can be feasibly performed by a well-experienced surgical team, via the novel robotic surgical platform, the SR-ENS-600 platform, for strictly-selected patients. With its preferable instrument maneuverability and stability, the multisite dissection and fine anatomy required by coloproctology malignant oncological surgery may be feasibly achieved through a single abdominal incision. Although the initial experience was encouraging and promising, further explorations and larger-scale data from multicenter randomized controlled trials are expected.

Ethical approval

The study procedures were approved by the ethics committee of Shanghai Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine (NO. KF-600-3-705) was registered at NCT05486299 (https://clinicaltrials.gov/ct2/show/NCT05486299?term=NCT05486299&draw=2&rank=1).

Sources of funding

This study was supported by the Shanghai Science and Technology Commission, 18ZR1424300 (R.Z.); Shanghai Hospital Development Center, SHDC2020CR1026B (R.Z); Shanghai Health Commission, 2019SY058 (R.Z.); National Natural Science Foundation of China, 82002475 (X.C.); Shanghai "Rising Stars of Medical Talents" Youth Development Program, Youth Medical Talents - Specialist Program (X.C.); National Natural Science Foundation of China, 82202839 (T.Z.); Shanghai Anticancer Association EYAS PROJECT, SACA-CY21C10 (K.L.).

Author contribution

Z.G.: data curation, formal analysis, methodology, visualization, writing – original draft, and writing – review and editing; Y.S.: data curation, formal analysis, methodology, visualization, and writing – original draft; Z.S.: data curation, methodology, visualization, and writing – original draft; W.J.: data curation, methodology, visualization, and writing – original draft; S.W.: data curation; Y.Z.: data curation; X.J.: data curation and supervision; K.L.: conceptualization, supervision, methodology; T.Z.: writing – review and editing, visualization, data curation, supervision, methodology; X.C.: conceptualization, data curation, methodology, supervision, and writing – review and editing; R.Z.: conceptualization, formal analysis, funding acquisition, methodology, supervision, and writing – review and editing.

Conflicts of interest disclosures

The authors declare that they have no financial conflict of interest with regard to the content of this report.

Research registration unique identifying number (UIN)

1. Name of the registry: Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery.

2. Unique identifying number or registration ID: NCT05486299.

3. Hyperlink to your specific registration (must be publicly accessible and will be checked): https://clinicaltrials.gov/ct2/show/NCT05486299?term=NCT05486299&draw=2&rank=1

Guarantor

Ren Zhao, Xi Cheng, Tao Zhang, and Kun Liu.

Data availability statement

The data that support the study findings are available upon reasonable request from the corresponding authors [Ren Zhao, Xi Cheng, Tao Zhang, and Kun Liu].

Supplementary Material

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