End‐to‐end Anastomosis With ECHELON ENDOPATH™ Staple Line Reinforcement for Right‐sided Colon Cancer: Safety and Feasibility

Abstract

Background/Aim

Functional end-to-end anastomosis (FEEA) is widely utilized in right-sided colorectal cancer surgery for joining the colon and ileum using mechanical staplers. ECHELON ENDOPATH™ Staple Line Reinforcement (SLR), a synthetic absorbable material introduced in 2020, represents a novel approach to reinforcing the anastomosis. However, surgical outcomes of FEEA utilizing SLR remain unreported in the literature. This retrospective study aimed to evaluate the efficacy and safety of FEEA with SLR compared to conventional FEEA in elective right-sided colon cancer surgery.

Patients and Methods

We conducted a retrospective analysis of 159 consecutive patients who underwent elective surgery for right-sided colon cancer at our institution between February 2019 and December 2022. Short-term surgical outcomes were compared between cohorts receiving FEEA with and without SLR.

Results

Analysis revealed no significant differences between groups in operative time, blood loss, postoperative hospital stay duration, or overall complication rates. The SLR group demonstrated a significantly higher proportion of robotic surgical procedures (p<0.001). Intraoperative staple line intervention was less frequently required in the SLR group (p=0.012). While one case of postoperative anastomotic leakage was documented in the non-SLR group, no such complications were observed in the SLR group.

Conclusion

SLR represents a safe and effective adjunctive technique for FEEA in right-sided colon cancer surgery. Further validation through larger prospective studies is warranted to confirm these preliminary results.

Introduction

Automatic suturing devices have become integral to colorectal cancer surgery, offering expeditious and reliable methods for intestinal dissection and anastomosis. Functional end-to-end anastomosis (FEEA) between the ileum and colon utilizing these devices represents the standard approach in right-sided colorectal cancer procedures, including ileocecal resection and right hemicolectomy. The evolution of automatic suturing devices has been driven by the continuous pursuit of reducing postoperative complications.

Nevertheless, anastomotic leakage (AL) persists as a significant challenge, with an approximate incidence of 2.2% in robotic or laparoscopic right-sided colorectal cancer procedures. This complication substantially Figure 1increases patient morbidity, healthcare resource utilization, and mortality rates (1,2). Despite refinements in patient selection criteria and surgical techniques, complete elimination of anastomotic leakage risk remains elusive (3). In response to this challenge, various staple line and anastomotic reinforcement methodologies have been developed, with particular emphasis on staple line reinforcement techniques.

Figure 1.

ECHELON ENDOPATH™ staple line reinforcement.

The ECHELON ENDOPATH™ Staple Line Reinforcement (SLR), introduced in 2020, represents a novel synthetic absorbable material comprising glycolic acid-lactic acid polyester and polydioxanone (Figure 1). This technology has been integrated into the established ECHELON FLEX platform, designed to mitigate staple line leakage and enhance hemostasis through improved anastomotic compressive strength.

The present study aimed to evaluate the comparative surgical outcomes of FEEA procedures performed with and without SLR, specifically investigating its potential role in reducing anastomotic complications in right-sided colorectal cancer surgery.

Patients and Methods

We included 159 patients who underwent elective surgery for right-sided colon cancer between February 2019 and December 2022 in our institution. In this study, right-sided colon cancer was defined as adenocarcinoma arising from the cecum, ascending colon, or transverse colon. Surgeries for cecum and ascending colon cancer with anastomosis of the colon and ileum (ileal resection) and for transverse colon cancer (right hemicolectomy) were also included in this study. The short-term outcomes of these surgeries were analyzed retrospectively.

All patients gave written informed consent to participate in the study. Inclusion criteria were: a right colonic adenocarcinoma confirmed by biopsy; American Society of Anesthesiologists (ASA) fitness grade I, II or III; surgery with a curative intention; and tumor location in the caecum, ascending colon or hepatic flexure. Exclusion criteria were: refusal to participate in the study; locally advanced tumor (cT4b) or tumor-nodes-metastasis (TNM) stage IV; emergency surgery; need for more than one simultaneous surgical procedure; and extended right colectomy with sectioning of the middle colic vessels or segmental resection.

Robotic surgery was introduced at our institution in October 2022 and was indicated for tumors up to cT1-4a. The decision to use SLR was based on the surgeon’s preference. Patient data, including age, sex, body mass index (BMI), ASA score, and TNM stage, were collected retrospectively from electronic medical records. Postoperative complications were classified as grade 2 or higher according to the Clavien-Dindo classification (5). At our facility, surgical operation records routinely included details about whether additional sutures were required to control bleeding from the stapler line.

This study was approved by the Center for Appropriate Promotion of Clinical Research at the International Medical Center of Saitama Medical University (Approval No. 2022-028) and was conducted in accordance with the principles of the Declaration of Helsinki.

Surgical technique (SLR group). FEEA was performed extracorporeally in all cases. Intestinal blood perfusion was assessed using indocyanine green (ICG) fluorescence imaging prior to anastomosis. The ileum and colon were dissected and anastomosed using the Powered ECHELON FLEX^® Blue 60 mm. The common hole was closed using the ECHELON ENDOPATH™ Staple Line Reinforcement along with the Blue 60 mm stapler (Figure 2A and B). If bleeding was observed at the staple line, a Z-stitch with 4-0 absorbable sutures was used to control it.

Figure 2.

A) Closure of the common hole using a Blue 60-mm ECHELON ENDOPATH™ staple line reinforcement. B) Staple line reinforcement after anastomosis.

Surgical technique (Non SLR). The procedure is the same as in the SLR group except for the closure of the common hole. The common hole was then closed using the Blue 60 mm with the ECHELON FLEX^® Blue 60 mm.

Perioperative management. All patients were diagnosed with right colonic cancer by colonoscopy and biopsy of the lesion. Abdominal computed tomography (CT) and a routine blood test were performed routinely. Patients in both groups were admitted to the hospital one day before surgery. Patients admitted one day before surgery were prohibited from eating from the time of admission. Patients underwent mechanical colon preparation or preoperative prophylaxis with oral antibiotics. Postoperatively, patients began drinking water on the first day, were mobilized from bed, and transitioned to a full gruel diet on the third day. If there were no problems after the patients started eating, they were discharged from the hospital on the sixth or seventh day, and the first outpatient visit was made one month after surgery.

Statistical analysis. Statistical analyses were performed using JMP Pro 10 software (SAS Institute, Cary, NC, USA). Results are summarized as means and standard deviations, or medians and ranges for continuous variables; categorical variables are summarized as numbers and frequencies. Median and mean values were compared between groups using the Mann-Whitney test or the Chi-square test in univariate analyses. All postoperative complications were analyzed using Fisher’s exact test. Mortality was analyzed using Cox’s proportional hazards model. Significance was set at p<0.05.

Results

Patient`s characteristics. The baseline characteristics of all 159 patients are summarized in Table I. The SLR group comprised 90 cases, while the non-SLR group included 69 cases. The proportion of male patients was significantly higher in the non-SLR group compared to the SLR group (p=0.03). There were no significant differences between the two groups in terms of age, BMI, ASA fitness grade, or tumor location. Additionally, no significant differences were observed in TNM stage, T stage, or N classification between the groups (Table I).

Table I. Patient characteristics.

SLR: Staple line reinforcement. Data are shown as n (%) unless otherwise indicated. ^ap-Values calculated using Fisher’s exact test; ^bdata shown as median (range); ^cp-Values calculated using the Mann-Whitney U-test.

Surgical outcomes. The type of surgical procedure did not differ significantly between the two groups. Robotic surgery was performed significantly more often in the SLR group compared to the non-SLR group (p<0.001). There were no significant differences between the groups in terms of operative time, blood loss, postoperative hospital stay, or overall postoperative complications. Postoperative anastomotic bleeding occurred at similar rates in both groups (2 cases in each group: 2.2% vs. 2.9%, p=0.08). One case in the non-SLR group required a blood transfusion due to anastomotic bleeding. No abdominal abscesses were observed in either group.

However, interventions for staple line bleeding were significantly less frequent in the SLR group compared to the non-SLR group (p=0.012). One case of anastomotic leakage occurred in the non-SLR group, whereas no cases were reported in the SLR group (0% vs. 1.5%, p=0.89) (Table II).

Table II. Surgical outcomes.

SLR: Staple line reinforcement. Data are shown as n (%) unless otherwise indicated. ^ap-Values calculated using Fisher’s exact test; ^bdata shown as median (range); ^cp-Values calculated using the Mann-Whitney U-test.

Discussion

This study compared the surgical outcomes of functional end-to-end anastomosis (FEEA) in right-sided colon cancer between two groups: those who underwent surgery with SLR and those without. While there was no significant difference in overall postoperative complications, the number of cases requiring anastomotic reinforcement due to intraoperative anastomotic bleeding was significantly lower in the SLR group compared to the non-SLR group.

Anastomotic complications, such as bleeding and leakage, are serious and potentially fatal issues following colorectal cancer surgery. Over the years, various automatic suturing devices have been developed to mitigate these risks (6-9). Several recent studies have demonstrated the efficacy of suture reinforcement for staple lines in preventing anastomotic complications (10-14). When using automatic suturing devices, issues such as tissue displacement and staple intersection during anastomosis can lead to imperfect staple formation (15-17). Techniques such as pre-compression of the tissue and delayed firing have been explored to address these issues. In this study, anastomotic leakage was not statistically significant between the groups; however, no cases of anastomotic leakage occurred in the SLR group.

Functional end-to-end anastomosis (FEEA) of the terminal ileum and colon in right-sided colon cancer surgery is conventionally performed using automatic suturing devices. A large-scale Japanese clinical trial (JCOG0404) reported a 3.6% incidence of postoperative anastomotic leakage in right-sided colon cancer for both open and laparoscopic approaches (18). These findings were corroborated by a Danish study that documented a 3.8% leakage rate (6). Notably, our study demonstrated no occurrences of anastomotic leakage or intra-abdominal abscesses in the SLR group, with no increased incidence of adhesive ileus, suggesting minimal adverse effects associated with SLR implementation.

Similar outcomes have been documented with the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology^® (Reinforce: Medtronic, Minneapolis, MN, USA), a device comparable to SLR (14). The reinforcement group demonstrated superior staple formation at intersection points compared to conventional stapling. Furthermore, in heterogeneous tissue environments (such as stomach and colon), staple formation exhibited greater consistency in the reinforcement group. The polyglycolic acid component of the reinforcement material was postulated to provide uniform tissue compression along the staple line, thereby preventing tissue displacement at intersection points (19). A separate investigation of glycolide copolymer staple line reinforcement in laparoscopic gastric bypass procedures demonstrated significantly reduced staple line bleeding and lower anastomotic bleeding rates (20). Furthermore, Namikawa et al. have reported that the use of staple line reinforcement during laparoscopic gastrectomy for gastric cancer significantly reduces the incidence of hemostasis during anastomosis (21). These findings support the hypothesis that SLR may mitigate stapler malformation, postoperative leakage, and anastomotic bleeding.

In our cohort, the incidence of Clavien-Dindo grade 3a postoperative anastomotic bleeding was 1.1%, with no cases of postoperative leakage observed. When compared to the reported 3.6% leakage rate in Japanese populations, these results suggest potential preventive benefits of SLR in right-sided colon cancer surgery (18). While postoperative anastomotic bleeding rates were comparable between SLR and non-SLR groups, intraoperative staple line oozing was significantly reduced in the SLR group (7.7% versus 23.2% in the non-SLR group). This observation suggests that SLR may streamline surgical procedures by reducing the necessity for hemostatic interventions.

However, the higher cost associated with reinforced staplers warrants consideration. Alexandra et al. (22) demonstrated that while reinforced staplers reduced minor postoperative bleeding in laparoscopic sleeve gastrectomy, their routine implementation was not cost-effective, as they failed to significantly impact major bleeding or leakage rates. This economic aspect merits further investigation in future studies.

Study limitations. First, its retrospective, single-institution design and relatively modest sample size may limit generalizability. Second, comprehensive evaluation of postoperative anastomotic bleeding into the intestinal lumen was constrained, as colonoscopic assessment was restricted to cases presenting with persistent hemato-chezia. Despite extensive literature documenting the efficacy of staple reinforcement agents, data specifically addressing clinical outcomes of FEEA utilizing SLR remains limited. Additional large-scale, prospective studies are essential to validate these findings.

Conclusion

Our findings suggest that SLR represents a safe and effective adjunctive technique for FEEA in right-sided colon cancer surgery. Further prospective investigations are warranted to confirm these results and evaluate the cost-effectiveness of SLR implementation.

Funding

None.

Conflicts of Interest

Megumi Sasaki, Yasumitsu Hirano, Sohei Akuta, Masatoshi Yoshizawa, Misuzu Yamato, Akihito Nakanishi, Yume Minagawa, Hisashi Hayashi, Takatsugu Fujii, Naoto Okazaki, Chikashi Hiranuma have no conflicts of interest or financial ties to disclose in relation to this study.

Authors’ Contributions

M S, Y. I and Y.H designed the study and performed the experiments; M.S, Y.I, Y.H, T.F, and N.O wrote the manuscript. Y.I, M.S, Y.H drafted the original manuscript. Y.H supervised the conduct of this study. All Authors approved the final version of the manuscript to be published.

Acknowledgements

The Authors would like to thank Editage (www.editage.jp) for English language editing.