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research-article2014

SRIXXX10.1177/1553350614540812Surgical InnovationSurgical InnovationKvasha et al

Article

Novel Totally Laparoscopic Endolumenal Rectal Resection With Transanal Natural Orifice Specimen Extraction (NOSE) Without Rectal Stump Opening: A Modification of Our Recently Published Clean Surgical Technique in a Porcine Model

Surgical Innovation 1­–7 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1553350614540812 sri.sagepub.com

Anton Kvasha, MD1,2, Amram Hadary, MD1,2, Seema Biswas, MD1,2, Sergio Szvalb, MD1,2, Udi Willenz, DVM3, and Igor Waksman, MD1,2

Abstract Our group has recently described a novel technique for clean endolumenal bowel resection, in which abdominal and transanal approaches were used. In the current study, 2 modifications of this procedure were tested for feasibility in a porcine model. A laparoscopic approach to the peritoneal cavity was employed in rectal mobilization; this was followed by a transanal rectorectal intussusception and pull-through (IPT). IPT was established in a stepwise fashion. First, the proximal margin of resection was attached to the shaft of the anvil of an end-to-end circular stapler with a ligature around the rectum. Second, this complex was pulled transanally to produce IPT. Once IPT was established, a second ligature was placed around the rectum approximating the proximal and distal resection margins. This was followed by a purse string suture through 2 bowel walls, encircling the shaft of the anvil just proximal to the ligatures. The specimen was resected and extracted by making a full-thickness incision through the 2 bowel walls distal to the previously placed purse string suture and ligatures. The anastomosis was achieved by applying the stapler. The technique was found to be feasible. Peritoneal samples, collected after transanal specimen extraction, did not demonstrate bacterial growth. Although, this is a novel and evolving procedure, its minimally invasive nature, as well as aseptic bowel manipulation during endolumenal rectal resection, has the potential to limit the complications associated with abdominal wall incision and surgical site infection. Keywords totally laparoscopic, clean endolumenal rectal resection, NOSE, colorectal surgery, novel, NOTES

Introduction Minimally invasive surgery has evolved over the past 3 decades. The laparoscopic approach to colonic resection is advantageous when the parameters of mortality, morbidity, and hospital fees are considered.1 Natural orifice translumenal endoscopic surgery (NOTES) and surgery involving natural orifice specimen extraction (NOSE) are recent advances in minimally invasive procedures. The potential benefit of these techniques is currently under evaluation. Although laparoscopic surgery has been applied to colon and rectal resection since the early days of laparoscopy, to

date, the laparoscopic-assisted approach has prevailed in surgical practice. While this technique may imply the fashioning of an intracorporeal anastomosis, it still requires abdominal incision in order to extract the specimen. Such an incision carries well-studied complications of surgical site infection, herniation, and dehiscence. Elimination of 1

Ziv Medical Center, Zefad, Israel Bar Ilan Faculty of Medicine, Hanraita Sold, Zefad, Israel 3 Lahav Contract Research Organization, Kibbutz Lahav, Israel 2

Corresponding Author: Anton Kvasha, Haagana 10, Postal Code 21993, Carmiel, Israel. Email: [email protected]

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the requirement for abdominal incision, and the potential complications this entails, has been the motivation for the development of NOSE techniques. Many of these techniques make use of an open rectal stump. Such methods of specimen extraction following colectomy have been used since the 1990s.2 However, investigators in the field of abdominal surgery have voiced their concern regarding intra-abdominal contamination facilitated by an open rectal stump. In fact, the transcolonic approach to the peritoneal cavity carries the highest risk of contamination compared with transesophageal, transgastric, or transvaginal procedures.3 In this article, the feasibility of a novel, totally laparoscopic, clean, NOSE technique is reported in a porcine model. This operative technique is a combination of laparoscopic and transanal approaches for endolumenal rectal excision, followed by transanal extraction of the resected bowel, without rectal stump opening.

Methods The study and use of pigs as an animal model was approved by the Israeli National Council for Experiments on Animal Subjects. Five female pigs (Sus scrofa domestica), with an average weight of 67 kg, were used. Preoperative preparation consisted of a liquid diet for 48 hours prior to surgery, bowel cleansing with a monosodium phosphate anhydrous and disodium phosphate anhydrous combination, and an enema. Animals received general anesthesia and were placed in a supine position during surgery. Four trocars were placed in the lower abdomen (Figure 1), pneumoperitoneum was established, the rectum mobilized, and the rectal mesentery detached as close as possible to the bowel wall using the Sonicision, Cordless Ultrasonic Dissection Device (Covidien, North Haven, CT). An end-to-end circular stapler (Autosuture, EEA 31-mm single-use stapler with 4.8-mm staples; Covidien, North Haven, CT) connected extracorporeally to its anvil, was inserted transanally in the closed position. The stapler was then opened at the proximal margin of resection. Suture ligation was performed laparoscopically around the rectum at the proximal resection margin, 15 to 20 cm from the anus, attaching the rectum to the shaft of the anvil (Figures 2 and 3A). The stapler was then closed and pulled-through transanally to create a rectorectal intussusception and pull-through (IPT; Figure 3B). After IPT was established, the stapler was reopened extracorporeally. A second suture ligature was placed around the rectum at the distal resection margin, attaching it to the previously ligated bowel and the shaft of the anvil. This allowed the approximation of the proximal and distal resection margins. The approximation of the 2 resection margins was reinforced with a 0 nylon purse string suture through 2 bowel walls, encircling the shaft

Figure 1.  Four trocars placed in the lower abdomen of a female Sus scrofa domestica pig. This picture was taken after the resection and transanal extraction of the specimen.

Figure 2.  Laparoscopically placed suture ligation around the rectum at the proximal margin of resection over the shaft of the anvil.

of the anvil just proximal to the ligatures (Figure 3C). The specimen was resected and extracted by making a fullthickness incision through 2 bowel walls. This incision was made around the shaft of the anvil about 2 to 4 mm distal to the most superficial ligature (Figures 4A and 5). Maintaining the incision 2 to 4 mm distal to the most superficial ligature kept the edges of the bowel to be anastomosed within the staple circle without exceeding its radius. This ensured that each staple traversed only the thickness of 2 bowel walls once the stapler was applied (Figure 4B). The stapler was applied, and a rectorectal

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Figure 3.  Suture ligation placed around the rectum at the proximal margin of resection: this ligation attaches the rectum to the shaft of the anvil (A). The stapler is retracted transanally, creating a transanal pull-through of rectum and a rectorectal intussusception (B). Suture ligation (short) and a purse string suture through 2 bowel walls (long) placed around the rectum at the distal resection margin: This approximates the proximal and distal resection margins while holding them attaches to the shaft of the anvil (C).

Figure 4.  Resection of bowel between the resection margins by creating a full-thickness incision through 2 bowel walls circumferentially 2 to 4 mm distal to the ligatures (short) and the purse string suture (long) (A). Application of an end-to-end circular stapler (B). Anastomosis after its retraction into the abdominal cavity (C).

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Figure 5.  Proximal and distal margins of resection held together by a suture ligation (short) and a purse string suture (long) after specimen resection just before the application of the end-to-end circular stapler.

anastomosis created. This was allowed to retract into the abdomen (Figure 4B and C). Peritoneal fluid was sampled for aerobic and anaerobic bacteria after transanal specimen extraction. The pigs were sacrificed immediately after the experiment and necropsy was performed.

Results All 5 pigs underwent a totally laparoscopic endolumenal rectal resection utilizing the transanal IPT technique. The laparoscopically applied ligature around the rectum, at the proximal resection margin followed by closure of the stapler established a stable association between the bowel and the stapler. Transanal pull-through of the rectum connected to the stapler was performed without any hindrance, no dislocation of the anvil from the stapler was observed. The proximal and distal resection margins remained approximated over the shaft of the anvil after bowel resection in all 5 subjects. A 2- to 4-mm resection margin, distal to the ligatures was accomplished consistently in all 5 experimental subjects. No proximal margin slippage was observed. The mean time required for the establishment of transanal IPT, bowel resection, and the reestablishment of gastrointestinal tract continuity was 16 minutes (range, 14.5-17.6 minutes). The resected segments averaged 11.5 cm in length (range, 9.5-13.2 cm; Figure 6). No aerobic or anaerobic bacterial growth was observed in any of the peritoneal fluid samples obtained after the performance of the resection and transanal extraction of the specimen. The rectorectal anastomosis

Figure 6.  Rectorectal anastomosis marked by a black arrow (above), and resected bowel after the application of the stapler (below).

was harvested from animal subjects immediately after the procedure and preserved in formalin. Histological analysis showed standard features of an end-to-end anastomosis performed with a circular stapler.

Discussion Minimally invasive surgery is constantly evolving. As more minimally invasive techniques emerge,4 the evidence in support of this approach grows. Recently, laparoscopic-assisted (LA) and LA with intracorporeal anastomosis (ICA) techniques for right hemicolectomy were compared. ICA techniques have been found to comply with oncological principles and were reported to have improved postoperative comfort, reduced rates of postoperative emesis, and provided a faster return to regular diet.5 Laparoscopic right hemicolectomy with transvaginal extraction was found to be equivalent to the LA procedure in terms of adherence to the principles of oncological resection and was found to be superior to the LA procedure when postoperative pain and wound complications were evaluated.6 In spite of these positive results, many of the new minimally invasive procedures remain technically complex. These procedures may require skill sets, equipment, and staff currently not available in many surgical departments. Moreover, although many welcome the advances in minimally invasive surgery, intraperitoneal bacterial contamination is a concern of some authors when open rectal stump is used for transanal NOSE.3,7 While some surgeons express concern over peritoneal contamination as a part of open rectal stump transanal

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Kvasha et al NOSE, the literature on this subject is sparse. In fact, only one such prospective article, which assessed NOSE sigmoidectomy for diverticulitis, was cited in a 2011 review by Diana et al.8 The same group has since published another prospective study addressing peritoneal contamination associated with NOSE sigmoidectomy for diverticulitis.9 In both studies, asymptomatic bacterial contamination was found in 100% of peritoneal samples collected from patients after open rectal stump NOSE.9,10 Furthermore, recently published animal model studies, which addressed this topic, reported similar results.11,12 These findings are unlikely to dismiss the apprehension associated with open rectal stump transanal NOSE, particularly when compared with a contamination rate of 28% of non-NOSE laparoscopic colorectal procedures.13 Our research demonstrated the feasibility of a totally laparoscopic approach to clean endolumenal bowel resection and transanal specimen extraction without rectal stump opening. Furthermore, the advantage of the IPT technique, compared with open rectal stump NOSE techniques, was demonstrated in the lack of peritoneal cavity contamination. The main innovation of this method is endolumenal exclusion of a segment of bowel from the peritoneal cavity prior to its resection. This was accomplished by performing transanal IPT of the specimen and approximating the resection margins by 2 sequential ligations over a standard end-to-end circular stapler. Moreover, because the specimen is excluded from the peritoneal cavity and the resection margins face into the lumen, this procedure may be considered clean. Finally, a laparoscopic approach was used for the abdominal portion of this procedure. With the adoption of the laparoscopic approach, this novel technique allows the operator to perform a totally laparoscopic, clean, endolumenal colorectal resection with transanal specimen extraction, without mini laparotomy or rectal stump opening. Vital to this procedure, is the performance of bowel resection as close as possible to the ligatures to facilitate the proper use of the EEA stapler where each staple traverses the thickness of only 2 bowel walls once fired. However, in similar unpublished research we encountered slippage of the proximal margin on two occasions. To counter this, the transanal approach was modified in the current study: A purse string suture through 2 bowel walls was placed just proximal to the ligatures (Figures 3C and 5). The approximation of the resection margins, reinforced by the purse string suture, prevented proximal margin slippage. Most important, this modification ensured the effective application of the end-to-end circular stapler; each staple traversed the thickness of only 2 bowel walls on firing without proximal margin slippage. In fact, although a substantially different procedure, the

Figure 7.  Altemeier’s stapled technique with 2 purse string sutures applied to the proximal and distal margins of resection separately just prior to the application of the end-to-end circular stapler.

final step just prior to the application of the stapler is very similar to the Altemeier perineal rectosigmoidectomy. While Altemeier’s stapled technique makes use of 2 purse string sutures applied to the proximal and distal margins of resection separately (Figure 7), the technique presented here uses 1 such suture through 2 bowel walls. Therefore, with the modification of the procedure described in this study, its complications are expected to be similar in their incidence and nature to other nononcologic rectal resections. In this study, the proximal margin of resection is 15 to 20 cm from the anal verge. It is defined by the placement of the first ligature (Figure 3A). Its location is determined by the following factors: the length of the stapler onto which the ligation is performed, the blood supply to the proximal margin of resection, and the ability to mobilize the proximal margin of resection, so that it may extend several centimeters beyond the anal verge, permitting the extracorporeal anastomosis. When all considerations are taken into account, the most proximal resection margin in humans is in the region of the splenic flexure.

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A mass or mesentery associated with the resected bowel could hinder the accomplishment of IPT. Despite these limitations, a wide range of indications for the IPT technique exist, including the excision of rectal prolapse, benign rectal polyps not amenable to endoscopic resection, and T1N0M0 tumors suitable for transanal excision. Furthermore, well or moderately differentiated T1N0M0 tumors with no lymphatic, vascular, or perineural invasion; that are more than 4 cm wide; involving more than one third of the circumference of the rectum; and which are located too proximal for transanal excision are also potential targets for the IPT technique. It is difficult to assess how well the establishment of porcine IPT compares with the IPT of the human rectum. The achievement of IPT greatly depends on rectal dissection from the surrounding tissue as well as on the proximity of the dissection plane to the rectal wall. The fact that the pelvic portion of the porcine rectum is much longer than that of a human may actually make IPT establishment more challenging in a porcine model. Because of the anatomical differences in porcine rectal model and the human rectum, this technique may initially be well suited to patients presenting with rectal prolapse. With further experience, however, the procedure may be applied more widely. A survival study was precluded because of several anatomical factors of the porcine model that limited the maintenance of sufficient blood supply to the proximal margin of resection during transanal IPT.14 We do not expect the vasculature of the human colon and rectum to be a limiting factor in the application of the transanal IPT technique. Colo-anal anastomosis is common practice in colorectal surgery. Furthermore, transanal pullthrough, extra-anal colon resection, and successful reestablishment of gastrointestinal continuity have been reported in a human study using a different surgical technique.15 Although more investigation is warranted, the totally laparoscopic procedure reported in this article has the potential to limit surgical complications associated with laparotomy by using aseptic bowel manipulation during endolumenal colorectal resection and transanal specimen extraction without rectal stump opening or mini laparotomy. Furthermore, the IPT method may provide a clean port for bowel extraction as part of existing, as well as future minimally invasive NOSE techniques. Author Contributions Anton Kvasha, MD : Surgical technique development, animal model development, surgical technique performance, article writing and editing, figure drawings, photography.Amram Hadary, MD : article review and editing. Seema Biswas, MD : article review and editing. Sergio Szvalb, MD : histological evaluation.

Udi Willenz, DVM : animal anesthesia, animal care, photography. Igor Waksman, MD : surgical technique development, animal model development, surgical technique performance, article review and editing.

Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The author(s) received following financial support for the research, authorship, and/or publication of this article: The authors received funding from The Fund for Medical Research at Ziv Medical Center.

References 1. Masoomi H, Buchberg B, Nguyen B, Tung V, Stamos MJ, Mills S. Outcomes of laparoscopic versus open colectomy in elective surgery for diverticulitis. World J Surg. 2011;35:2143-2148. 2. Wexner SD, Edden Y. NOTES/NOSE/NOSCAR/LATAS: What does it all mean? Tech Coloproctol. 2009;13:1-3. 3. Bergman S, Melvin WS. Natural orifice translumenal endoscopic surgery. Surg Clin N Am. 2008;88:1131-1148. 4. Auyang ED, Santos BF, Enter DH, Hungness ES, Soper NJ. Natural orifice translumenal endoscopic surgery (NOTES): a technical review. Surg Endosc. 2011;10:3135-3148. 5. Scatizzi M, Kroning KC, Borrelli A, Andan G, Lenzi E, Feroci F. Extracorporeal versus intracorporeal anastomosis after laparoscopic right colectomy for cancer: a case-control study. World J Surg. 2010;34:2902-2908. 6. Park JS, Choi G-S, Kim HJ, Park SY, Jun SH. Natural orifice specimen extraction versus conventional laparoscopically assisted right hemicolectomy. Br J Surg. 2011;98:710-715. 7. Nishimura A, Kawahara M, Suda K, Makino S, Kawachi Y, Nikkuni K. Totally laparoscopic sigmoid colectomy with transanal specimen extraction. Surg Endosc. 2011;10: 3459-3463. 8. Diana M, Wall J, Costantino F, D’agostino J, Leroy J, Marescaux J. Transanal extraction of the specimen during laparoscopic colectomy. Colorectal Dis. 2011;13(suppl 7):23-27. 9. Costantino FA, Diana M, Wall J, Leroy J, Mutter D, Marescaux J. Prospective evaluation of peritoneal fluid contamination following transabdominal vs. transanal specimen extraction in laparoscopic left-sided colorectal resections. Surg Endosc. 2012;26:1495-1500. 10. Leroy J, Costantino F, Cahill RA, D’Agostino J, Morales A, Mutter D, Marescaux J. Laparoscopic resection with transanal specimen extraction for sigmoid diverticulitis. Br J Surg. 2011;98:1327-1334. 11. Guarner-Argente C, Beltrán M, Martínez-Pallí G, et al. Infection during natural orifice transluminal endoscopic surgery peritoneoscopy: a randomized comparative study

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Kvasha et al in a survival porcine model. J Minim Invasive Gynecol. 2011;18:741-746. 12. Diana M, Leroy J, Wall J, et al. Prospective experimental study of transrectal viscerotomy closure using transanal endoscopic suture vs. circular stapler: a step toward NOTES. Endoscopy. 2012;44:605-611. 13. Saida Y, Nagao J, Nakamura Y, et al. A comparison of abdominal cavity bacterial contamination of laparoscopy and laparotomy for colorectal cancers. Dig Surg. 2008;25:198-201.

14. Kvasha A, Kvasha V, Hadary A, Willenz U, Szvalb S, Waksman I. Endolumenal rectal resection and transanal natural orifice specimen extraction (NOSE) without rectal stump opening: a novel, clean surgical technique in a porcine model. Surg Innov. 2013;20:454-458. 15. Akamatsu H, Omori T, Oyama T, et al. Totally laparoscopic low anterior resection for lower rectal cancer: combination of a new technique for intracorporeal anastomosis with prolapsing technique. Dig Surg. 2009;26:446-450.

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Novel Totally Laparoscopic Endolumenal Rectal Resection With Transanal Natural Orifice Specimen Extraction (NOSE) Without Rectal Stump Opening: A Modification of Our Recently Published Clean Surgical Technique in a Porcine Model.

Our group has recently described a novel technique for clean endolumenal bowel resection, in which abdominal and transanal approaches were used. In th...
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