Laparoscopic-Assisted Transvaginal Cholecystectomy – the US Military Experience With Long-Term Follow Up

Abstract

Objectives:

We present our initial clinical experience applying Natural Orifice Transluminal Endoscopic Surgical (NOTES) technique to perform cholecystectomy in ten patients at a military institution.

Methods:

A posterior colpotomy was created to accommodate a single site working port used to facilitate dissection and gallbladder mobilization under direct visualization via an infraumbilical port. The specimen was retrieved through the vagina and the colpotomy was closed with absorbable suture under direct visualization. Long-term follow up was performed over the phone to assess quality of life with 2 widely used health-related quality of life (HRQoL) surveys including RAND-36 Health Item Survey (Version 1.0),¹ and the Female Sexual Function Index (FSFI).²

Results:

Ten women underwent a laparoscopic-assisted transvaginal cholecystectomy (TVC) with 7 available for long-term follow-up. The average age was 28.9 years (20–37) and the indications for surgery included symptomatic cholelithiasis (9) and biliary dyskinesia (1). The mean operative time was 129 mins (95–180), and median blood loss was 34 ml (5–400). There were no conversions and the average length of stay was 9.98 hours (2.4–28.8). Pain (analogue scale 1–10) on postoperative day three was minimal (mean 2.3) and was limited to the infraumbilical incision. On average patients returned to work by postoperative day six and resumed normal daily activities at seven days. Immediate postoperative complications included one incident of postoperative urinary retention requiring bladder catheterization. One intra-operative cholangiogram was successfully performed due to elevated preoperative liver enzymes without significant findings. Long-term complications included one asymptomatic incisional hernia repair at the infraumbilical port site. The RAND-36 survey demonstrated an average physical and mental health summary score of 82.2 and 63.7 with an average general health score of 63.6. The average FSFI total score was 21.8.

Conclusion:

TVC is safe and effective. Implementation may improve operational readiness by returning service members to normal activities more expeditiously than conventional laparoscopy.

INTRODUCTION

Natural orifice transluminal endoscopic surgery (NOTES) is a technique defined by surgery performed through a natural orifice and has been successfully applied to many procedures including appendectomy, sigmoidectomy, peroral esophageal myotomy, necrosectomy, and cholecystectomy.³ NOTES was first described by Kalloo et al in 2004 in response to the 1998 meeting of the Apollo Group, intended to drive innovation in endoscopic therapies.⁴ In 2005, SAGES and the ASGE created the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR), a framework for advancement in the field.³ Shortly thereafter, the first successful transvaginal cholecystectomies (TVCs) were described by several pioneering groups.^5–8

Since 2005, several large registries have demonstrated most NOTES procedures to be hybridized TVCs.^9–12 While innovative in cholecystectomy, the TV route for specimen extraction, has historical precedent for both gynecologic and nongynecologic procedures.^13–15 The first TV hysterectomy was reported 200 years ago¹⁶ and the technique of achieving entry to the abdominal cavity via posterior colpotomy has been described since the 1940s.¹⁷

Hybridized NOTES is differentiated from pure NOTES by virtue of a laparoscopic assist.³ While pure NOTES has been described,^8,18–20 it is rarely performed due to concern for inadequate instruments and increased technical difficulty.²¹ The primary technical challenges are thought to be associated with inability to achieve triangulation to facilitate safe and effective retraction, exposure, and dissection.²¹ Several randomized controlled trials have demonstrated the safety, efficacy, and noninferiority of TVC, but have not proven a clear benefit over conventional laparoscopic cholecystectomy (CLC).^22–25 TVC may cause less postoperative pain than CLC^25–33 and has been associated with a shorter LOS^9,26 and faster recovery,^{30,31,34–36} but this remains controversial in the literature.

We sought to evaluate the safety and efficacy of TVC performed in a population of active duty service members and their families at a military treatment facility. We studied the impact of TVC on patients returning to work. Our primary objective ascertained if this technique, as compared to CLC, can expedite the return of the patient to work – or the return of the warfighter to the battlefield, to improve operational readiness, reduce periods of vulnerability, and support military lethality.

MATERIALS AND METHODS

A prospective institutional review board (IRB) approved study of 10 women with nonurgent indications for cholecystectomy was performed. From Dec 2009 through Jan 2016 TVC was offered to female active duty, retired military personnel and their beneficiaries. There was significant delay in publishing these results due to war-time operational tempo, military training demands, and a recent pandemic. Inclusion criteria included between ages 18 to 50 years old, with a clinical indication for cholecystectomy and American Society of Anesthesiologists (ASA) classification of I. Exclusion criteria included radiographic evidence of possible gallbladder malignancy or choledocholithiasis, prior open abdominal or TV surgery, body mass index (BMI) ≥ 35, pregnancy, history of pelvic inflammatory disease, ectopic pregnancy, severe endometriosis, or use of anticoagulant therapy.

All patients participating in this protocol received counseling by the principal investigator (PI) on the TVC technique as well as potential risks and benefits as compared to CLC. The PI was the primary surgeon and had fellowship training in minimally invasive surgery as well as NOTES techniques. Prior to initiation of the study, the team, consisting of general surgery and support from the Department of Gynecology trained in the TV approach, honed the technique in a series of cadaver and swine training sessions. Postoperatively all patients maintained logs for one week following surgery and were questioned as to whether they would recommend the procedure to a friend.

Five year follow up included all patients also receiving a RAND 36-Item Health Survey (Version 1.0).¹ The RAND is a widely used health-related quality of life (HRQoL) survey, which assesses the impact of health on an individual’s perceived well-being across 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.¹ Each item is scored linearly from 0 to 100 such that a higher number represents a more desirable state of health.¹ A physical health summary score is calculated by averaging the scores of physical functioning, physical role limitations, pain, and general health.³⁷ A mental health summary score is calculated by averaging the scores of energy, social functioning, emotional role limitations, and mental health.³⁷

The Female Sexual Function Index (FSFI) questionnaire first described by Rosen in 2000,³⁸ is a 19-item self-report of female sexual function across 6 domains including arousal, desire, lubrication, orgasm, satisfaction, and pain. The sum of each domain is multiplied by a domain-specific factor to calculate the domain total.² Domain totals are then summed to calculate the FSFI total, shown to be suggestive of female sexual dysfunction over the preceding 4 weeks if ≤26.55 (specificity 0.733, sensitivity 0.889).³⁹ Of note, the FSFI cannot be used in isolation to diagnose female sexual dysfunction because there is no assessment of distress. It can give meaningful data over time reflecting response to intervention or treatment. The domain of desire can be evaluated independently using the established cutoff value of 5 to indicate hypoactive sexual disorder.⁴⁰ All other domains do not have proven cutoff values and therefore cannot be assessed independently.² The FSI has been validated on clinically diagnosed samples of women with female sexual arousal disorder (FSAD), female orgasmic disorder (FOD), and hypoactive sexual desire disorder (HSDD). All patients were also specifically examined for the presence of incisional hernia at 6 months postoperatively.

Operative Techniques

Following intubation, patients were placed in lithotomy (Figure 1) and a urinary catheter was inserted. The vaginal vault was prepared followed by the abdomen in the standard fashion.

Figure 1.

Patient and surgical team positioning. Endoscopic unit is a Stryker Tower^TM.

Pneumoperitoneum was established using a Veress needle in an infraumbilical position followed by introduction of an optically guided 5 mm trocar. After an initial visual assessment, the patient was placed in Trendelenburg. With the assistance of the gynecology team, the uterus was manipulated anteriorly to expose the posterior vaginal fornix.

Under direct visualization, a posterior colpotomy was created using a 15-mm Ethicon Endopath XCEL Bladeness Trocar™ port, which was then removed and replaced with a Triport™ (TriPort, Olympus, Center Valley, PA) single site port (Figure 2). The patient was placed in the standard cholecystectomy left decubitus position with reverse Trendelenburg.

Figure 2.

Olympus Triport™ (TriPort, Olympus, Center Valley, PA) single site port.

Dissection proceeded via the umbilical trocar facilitated by retraction and optics using a 10-mm 45°F laparoscope via the TV port. After the critical view of safety was obtained, the cystic duct and artery were ligated and divided between 5-mm metallic clips placed through the 5-mm umbilical port. Standard bariatric-length rigid and reusable instruments were used except for the Endograb^TM, intra-corporeal gallbladder retractor (Endograb, Virtual Ports, Caesarea, Israel). The specimen was removed transvaginally under laparoscopic visualization via the umbilical port. Colpotomy closure was performed with a running absorbable suture under direct visualization.

Patients were monitored for 2 hours postoperatively and were discharged in accordance with standard criteria. The patients were provided with a log to record their pain levels and medication use for 7 days postoperatively. Follow-up was arranged with the operating surgeon 1 and 2 weeks postoperatively and separately with the Department of Gynecology.

RESULTS

Successful TVC was performed in all ten patients although only 7 were able to be reached for long-term follow-up. There was one intra-operative cholangiogram for elevated preoperative liver enzymes without significant findings and one planned concomitant tubal ligation. The mean operating time was just over two hours and decreased over the course of the study. There was an average estimated blood loss of 34 mL and no intra-operative complications. The average length of stay was 9.98 hours. Postoperative complications were limited to one incident of urinary retention requiring bladder catheterization.

Patient logs were inventoried and supplemented with virtual interviews as well as the FSFI and RAND-36 surveys at one month and 5 years postoperatively respectively. The average pain on postoperative day 3 was 2.25 on a visual scale of 1–10 (Table 1). The average time to return to normal activities was reported as 7.33 days with an average time to return to work of 6 days. Postoperative pain patient logs did not quantify pain medication requirement. Complications included one asymptomatic umbilical port site hernia reported 1 year postoperatively. Of note, the patient who developed an umbilical hernia had a pre-existing hernia through which the 5-mm port was placed. There were no reports of postoperative fever or weight change.

Table 1.

Patient Outcomes

Patient	f/u Years	Hernia	Pain
1	5	No	6.0
2	5	No	6.0
3	5	No	3.6
4	5	No	3.6
5	5	No	0.0
6	5	No	5.6
7	4	Yes	5.2

The average FSFI total score was 21.8 (Table 2). The only independently assessable domain, desire, had an average score of 3.8. The RAND-36 survey demonstrated an average physical and mental health summary score of 82.2 and 63.7 with an average general health score of 63.6 (Table 3).

Table 2.

FSFI Questionnaire Results

Patient	FSFI	Desire	Arousal	Lubrication	Orgasm	Satisfaction	Pain
1	31.4	3.6	5.4	6	5.2	5.2	6
2	34.2	4.8	5.7	5.7	6	6	6
3	22.4	3.6	3.3	5.1	4	2.8	3.6
4	12.9	1.2	1.5	3	2	1.6	3.6
5	6	4.8	0	0	0	1.2	0
6	26	2.4	3.6	3.6	5.2	5.6	5.6
7	19.4	6	4.2	0	0	4	5.2

Table 3.

RAND 36 Health Survey (Version 1) Results

Patient	PCS	MCS	Physical Function	Physical Role Limits	Emotional Role Limits	Energy	Emotional Well-Being	Social Function	Pain	General Health
1	88.8	90.8	100.0	100.0	100.0	75.0	88.0	100.0	80.0	75.0
2	84.4	88.5	95.0	100.0	100.0	70.0	84.0	100.0	77.5	65.0
3	69.4	37.9	100.0	75.0	0.0	25.0	64.0	62.5	57.5	45.0
4	69.4	41.5	80.0	75.0	33.3	30.0	40.0	62.5	67.5	55.0
5	95.0	64.3	100.0	100.0	33.3	65.0	84.0	75.0	100.0	80.0
6	82.5	59.1	90.0	100.0	33.3	60.0	68.0	75.0	90.0	50.0
7	86.3	82.1	80.0	100.0	100.0	65.0	76.0	87.5	90.0	75.0
Mean:	82.2	63.7	92.1	92.9	57.1	55.7	55.7	80.4	80.4	63.6

Abbreviations: PCS, physical composite score, MCS, mental composite score.

DISCUSSION

TVC has been widely demonstrated to be noninferior to CLC and may be associated with decreased postoperative pain,^26–30 shorter length of stay,²⁶ and possible faster return to work,^{30,34–36,41} as well as improved cosmesis.^26,27,34 Additionally, complications have been comparable to CLC.^{22,24–26,28–30,34} Despite the potential advantages and proven safety profile, there has been declining interest over the almost 20 years since the technique was first described.^9,42

In a systematic review of patient's perception of NOTES procedures, Pucher et al observed an overall 41%–41% acceptance rate suggesting strong interest.⁴³ Of those patients who have had TVC, 93% would recommend the procedure to another patient.²² Motivating factors include the perception of reduced pain and recovery time, improved cosmesis, and reduced risk of hernia.⁴³ Patient concerns, including those of male partners, have primarily centered on uncertainty regarding the effect on future pregnancies and sexual function particularly among younger women.^44–48 Interestingly, patients with a medical education have been shown to be significantly less likely to choose NOTES procedures than those without.⁴⁴ In a survey of 600 resident and attending surgeons, 91.5% reported they would not choose a single-incision or NOTES procedure for themselves.⁴⁹

The primary patient concerns regarding sexual health and future pregnancies have been largely disproven in the literature. Colpotomy in the setting of TVC has not been shown to have any negative affect on female sexual function, quality of life,^26,50–54 or pregnancy.⁵⁴ In a retrospective cohort study of 88 patients, Bulian et al observed no significant changes in postoperative sexual function, menorrhea, or vaginal discharge at an average of two years postoperatively from TVC.³⁵ A subsequent systematic review by Donatsky et al reported rates of de novo dyspareunia and vaginal pain or discomfort following TVC between 0% and 12.5% with no impairment of sexual function noted.⁵³ Additionally, there is no evidence that NOTES procedures using TV access have any negative effect on conception, pregnancy, or delivery.⁵⁴

NOTES procedures have also been shown to cause less pain than conventional laparoscopy,¹² however, data pertaining to TVC specifically in support of this finding is limited to meta-analyses^26–30 and prospective cohort studies^31–33 and has not been reproduced in randomized controlled trials.^22,24,25 The International Multicenter Trial on Clinical Natural Orifice Surgery (IMTN) Registry captured 362 patients from 16 centers across 9 countries having undergone NOTES procedures and demonstrated less pain in NOTES patients than in those having had conventional laparoscopy.¹² While this study is inclusive of all NOTES procedures, Ghezzi et al demonstrated significantly less pain following TV specimen extraction than transumbilical extraction suggesting a consistent relationship.⁵⁵ While randomized controlled trials comparing TVC to CLC have not detected a difference in postoperative pain, they may have been limited by inconsistent methods of pain assessment and ineffective poor blinding procedures.^22,24,25 Furthermore, pain assessment methods such as having the patient cough while lying in bed may not accurately elicit pain which might be evident with activity.²⁴

Incisional pain is of particular interest to our study because it is the primary factor related to delay of discharge and return to normal activity in patients after CVC.⁵⁶ While some studies have shown a reduced length of stay²⁶ and faster recovery,^{30,34–36,41} others have not.^{22,24,25,28,29} Of note, these findings may be confounded by institutional mandates such as the routine two-day hospital stay following laparoscopic cholecystectomy in Germany.^34,57 Medication use, perhaps a better indicator of postoperative pain, may be reduced in patients following TVC as compared to CLC.^26,31,33,41 Lehmann et al reported that 25% of NOTES patients captured in the German National Registry (GNR) had no pain medication requirement at all.¹⁰ While analgesia use has been inconsistently reported and not clearly associated with a universally decreased length of stay, there are multiple large series demonstrating no postoperative analgesia in significant portions of patients.^10,12

Another factor potentially contributing to pain is variability in the number of additional abdominal trocars used beyond the single port for hybridized assist. Additional trocars have been reported in up to 8.6% of TVC²⁶ with a mean of between 1.3 and 1.45 in large series.^10,22,32 Although the conversion rate to conventional laparoscopy is between 2%–2%,^22,26 the definition of conversion is unclear. Further studies are needed to determine if, given the known learning curve, experience with NOTES procedures is correlated with decreased number of additional abdominal trocars and perhaps reduced pain. Regardless, the overall patient satisfaction and cosmetic result has been shown to be significantly improved amongst TVC patients as compared to CLC.^{25–27,57–59}

In addition to reduced or equivalent postoperative pain, there is no evidence of increased complications in TVC as compared to CLC.^{22,24–26,28–30,34} In a retrospective analysis of 571 TVCs over a 10-year period, Rössler et al observed a major complication rate of 1.6%.⁶⁰ The incidence of bile duct injuries has been reported as 0.7%, slightly higher than in conventional laparoscopy.⁶¹ Interestingly, all bile duct injuries occurred in elective surgeries and were treated successfully with ERCP and stenting.⁶⁰ In a systematic review and meta-analysis Sodergren et al did not note any significant differences in the rate of bile duct injury between TVC and CLC, although it is a rare event irrespective of approach and the studies included may not have been adequately powered to detect a difference.³⁴ Minor complications such as vaginal bleeding have been reported but observed to stop spontaneously or with direct pressure.²⁶ Theoretical complications include bowel herniation and vaginal cuff dehiscence,¹⁸ but have not been reported in the literature to our knowledge. Complication reporting in NOTES procedures has lacked standardization, which may create variability in interpretation.⁶²

Access-related complications including injuries to the rectum, small bowel, and bladder have been reported,¹⁰ but there is significant data to support the safety of TV access.⁶³ In a retrospective review of 102 TV access procedures, Woods et al reported an overall complication rate of 9.8% with a significant decrease after 50 cases.⁶⁴ In a multinational retrospective study of 3,667 TV procedures performed by 44 gynecologists from 18 different countries, Gordts et al demonstrated a full thickness bowel injury rate of 0.65% which decreased to 0.25% after 50 cases and were all managed conservatively.⁶³ A learning curve of 10–15 cases amongst laparoscopic surgeons performing TVC has been reported.^65–67 Becerra et al noted greater improvement in those with less laparoscopic experience suggesting the importance of this skill and translation to NOTES using rigid instruments as opposed to flexible endoscopy.⁶⁶ Van Den Boezem et al reported a decrease in operative time from 90 minutes to 55 minutes after 10 cases.⁶⁵ The operative time has generally been shown to be longer in NOTES procedures and TVC specifically,^{22,24–26,28,29,34} but may decrease significantly with experience.

TV access has been further criticized for being limited to the female population, however, females are at increased risk of gallbladder pathology.⁶⁸ Although universally available, transgastric (TG) access may be associated with a more difficult closure than TV access which can be performed under direct visualization.^69–72 In the setting of cholecystectomy, TG access often involves visual inversion,⁵⁸ retroflexion, and additional laparoscopic suturing to facilitate gastrostomy closure.^12,71 There may be a greater learning curve in TG cholecystectomy due to the requirement for advanced endoscopic skills.¹² In their review of the IMTN Registry, Zorron et al found that TG surgery was associated with a higher rate of complications and longer operative time than TV access procedures.¹² The European clinical NOTES registry, captured an operative time in TG cholecystectomy almost double that of TVC and further associated with an increased requirement for additional trocar placement, and conversion to laparoscopy.⁹ TG surgery is also limited by the esophageal diameter to the extraction of relatively smaller specimens than the TV access.¹² Conversely, extraction of pelvic masses up to 19 cm via posterior colpotomy has been reported without access-related morbidity.⁵⁵

There has been additional hesitancy to pursue TV access as it requires incision of an otherwise uninvolved organ and was thought to potentially contaminate the peritoneum. While the colpotomy is typically five times as large as standard laparoscopic ports,²⁸ there have been no reports to our knowledge of prolapse or complications associated with the incision itself. Peritoneal contamination following TV procedures has been demonstrated in preclinical models to be low.^73–75 Lomanto et al specifically compared TV to TG access and found a lower risk of intra-abdominal contamination and sepsis in TV procedures.⁷³ Preclinical studies have further demonstrated minimal and abridged systemic inflammation and a decreased immunologic response relative to CLC.^75–77

Contraindications to TVC access are widely variable, but generally extend to infectious and inflammatory disease of the abdomen or pelvis to include acute cholecystitis, as well as prior surgery.^{12,18,34,65,78} TVC has also historically not been offered to patients with a BMI over 35,⁷⁹ due to data associating obesity with increased operative time in laparoscopic cholecystectomy^80–82 and increased risk of conversion from laparoscopic to open cholecystectomy,^83,84 suggesting a more difficult procedure with an increased risk of complications. The safety and efficacy of NOTES TVC as an alternative to conventional laparoscopy in the morbidly obese has been proven.^69,85–88 The available data suggest there is no increased risk of complications or pain in TVC performed in obese patients as compared to nonobese.^10,85–87 Increasing BMI may be associated increased rates of conversion to open, longer operative time, higher number of percutaneous trocars, and increased length of stay.^10,86 Some studies, however, observed no relationship between operative time and BMI.⁸⁵

TVC has also been successfully performed in patients with prior abdominal surgery to include hysterectomy as well as gastric bypass and sleeve procedures.^33,60,79,89 Given the altered anatomy and potential for adhesions especially in vicinity of the posterior vaginal vault, hysterectomy may increase the risk of complications particularly those related to access such as urinary bladder perforation.⁸⁹ The GNR demonstrated an increased incidence of bladder injury amongst patients with prior hysterectomy.¹¹ Rössler et al, however, in their review of 571 TVC’s over a 10-year period, found no difference.⁶⁰ While the data are unclear regarding the incidence of bladder injury in this demographic, the overall complications have not been shown to be increased despite longer associated operating times.⁸⁹

Key steps of TVC are the choice of endoscope, establishment of peritoneal access, dissection, extraction, and closure of the access site.⁹⁰ Issues surrounding NOTES include poor operative field visibility, limited instrument maneuverability, increased grasping distances, and lack of specific suturing and anastomotic devices designed for NOTES.³ TVC typically requires adaptive curved instruments significantly longer than those for laparoscopic surgery.^91,92 There is significant heterogeneity in procedural methodology and equipment. Both flexible^6,69 and rigid^8,79,93,94 instruments have been described as has the use of modified transanal endoscopic microsurgery equipment.⁹¹

The primary challenges associated with TVC and, pure NOTES TVC especially, are related to the colocation of instruments. Operative instruments and endoscopes working in parallel create the possibility for interferences, hinders effective manipulation, and does not facilitate triangulation as movement is constrained to the long axis.^58,94–96 This may significantly limit exposure, dissection, and field of view potentially increasing the risk of injury while instruments are out of sight.⁹⁷ In a task-analysis of CLC versus TVC, Nemani et al demonstrated increased errors in the TVC group due to instruments being out of sight whereas the CLC group had more errors due to lack of progress.⁹⁸ It may also be more difficult to obtain the critical view of safety while working from a relatively more posterior angle.¹⁸

Hybridization is the predominant approach in TVC because it addresses many of these challenges.¹⁰ It also facilitates the passage of surgical clips, which is critical as historically available endoscopic clips are not intended and should not be used for full occlusion of the cystic artery and/or duct.^18,58,72,96 Endoscopic clips may become dislodged^99–101 and cannot achieve complete occlusion due to a hinge gap such that they are only occlusive at the distal tip.^7,18,102 Some authors have described manual straightening of endoscopic clips to mitigate this issue and facilitate placement, however, while successful, this technique is inefficient and not ideal given that it requires modifying a manufactured product.^18,95 Prototype flexible clip appliers capable of complete occlusion have been described¹⁰³ including one with a zero-gap clip.⁹⁷ Of note, clip placement using this prototype took 9 minutes, significantly longer than laparoscopic clip placement.⁹⁷

In addition to the variable approach, there is also the choice of flexible or rigid instruments, both of which have been widely reported. Flexible endoscopes offer working ports for instruments, but require an additional skill set and potentially significant cost should equipment not be readily available.⁹⁰ Furthermore, platform stability is sacrificed for maneuverability which may compromise the ability to create sufficient axial force, traction, and countertraction to facilitate efficient exposure and dissection.^90,96 While the grasper allows for some traction, the endoscope is unable to simultaneously dissect.⁹⁵ Rigid instruments allow for improved stability, resolution, field of view, and picture quality as well as independence of working instruments from visualization.⁹⁰ Conversely, they are limited to access near natural orifices and dissection in-line with the direction of access.⁹⁰ In a review of the EURO-NOTES Clinical Registry, inclusive of all NOTES procedures in the first five years of its clinical implementation, Arezzo et al demonstrated a significantly shorter operative time overall using rigid instruments as compared to flexible instruments.⁹

The lack of NOTES-specific instruments, a process significantly delayed by federal regulations, has been a major issue in limiting adoption.³ Additional issues with current procedural terminology (CPT), coding process, third-party-payer approvals, and hospital credentialing and purchasing processes as well as the requirement for IRB approval on all NOTES procedures, have also contributed to delayed integration.³ Instruments not only NOTES-compatible, but designed to address specific associated challenges, are available.¹⁰⁴ Magnetic anchoring systems (MAS), for example, may allow for triangulation by improving the stability of flexible platforms facilitating multiaxial traction and countertraction in NOTES procedures by coupling internal components to external components.^104–106 Preclinical studies of MAS experienced failures attributed to inadvertent magnetic coupling, but noted significant improvement over time as technique was refined.¹⁰⁴ Even with appropriate equipment, however, it has been suggested that robotization may be necessary before more widespread adoption is possible.¹⁰⁷ Robotic systems specific to endoluminal procedures have been developed^108,109 and shown in randomized controlled trials to improve dissection and shorten operating time.¹¹⁰

There are several limitations to this study. This prospective study had a small sample size and the operations were completed over a decade ago. The population of patients was restricted to military personnel and their family members undergoing elective and highly selective cases. Lastly, the amount of pain medication taken postoperatively was not collected and therefore no comment on the relationship between TVC and postoperative pain medication requirement is available. Definitive conclusions from this data cannot be applied to the general population.

Importantly, the HRQoL surveys chosen for long-term follow up likely report results irrelevant to the index NOTES procedure. The results of the RAND-36 and the FSFI have limited relevance due to the collection in isolation and lack of established patient’s baseline, which make it difficult to assess the effect of the operation on these outcomes. Furthermore, the RAND-36 was conducted 5 years postoperatively at which time their quality of life as assessed by the survey was likely temporally separated from the effect of the operation because they had fully recovered. The FSFI was discordant from patient logs and showed most patients to have results suggestive of female sexual dysfunction and hypoactive sexual disorder. Importantly, FSFI is not diagnostic of female sexual dysfunction because it does not assess distress and, therefore, these findings are highly unlikely that all seven women had results objectively suggestive of this disorder without any endorsing symptoms elsewhere. We recommend future research efforts conduct both the RAND-36 and the FSFI prior to study initiation and at more than one time point postoperatively, to establish a baseline and better informed data interpretation.

The military relevant benefits of this technique are primarily related to the potential for expedited return of the warfighter back to the fight and limited restrictions for service member return to work. Future use of NOTES techniques in forward deployed environment may obviate the requirement for a sterile operating room environment, provide procedures that are less resource demanding and allow for broader implementation of invasive procedures performed closer to the point of injury as well as to service members in austere environments.

In conclusion, TVC is a novel technique which may improve operational readiness by returning service members to normal activities more expeditiously than traditional laparoscopy. Further research is to understand if there are significant decreases in pain, wound infection, complications, operative times associated with NOTES TVC.