Surgery for Obesity and Related Diseases 4 (2008) 660 – 663
Rapid communication
Human hybrid NOTES transvaginal sleeve gastrectomy: initial experience Almino Cardoso Ramos, M.D.a, Natan Zundel, M.D., F.A.C.S.b,*, Manoel Galvao Neto, M.D.c, Majed Maalouf, M.D.d a
Bariatric Surgery, Gastro Obeso Center, São Paulo, Brazil Consultant, Minimally Invasive and Bariatric Surgery, FSFB, Colombia c Bariatric Endoscopy, Gastro Obeso Center, São Paulo, Brazil d General Surgery, Alleghany General Hospital, Pittsburgh, Pennsylvania Received May 9, 2008; revised June 10, 2008; accepted June 27, 2008 b
Abstract
Laparoscopic sleeve gastrectomy is gaining popularity as a treatment of morbid obesity. It is a relatively new procedure with a postoperative follow-up not exceeding 5 years. The natural orifice transluminal endoscopic surgical procedures are also gaining in popularity, and we are now experiencing the first transition from animal to human trials. We describe the first sleeve gastrectomy surgery for morbid obesity using the vagina as the natural orifice in the form of a hybrid natural orifice transluminal endoscopic surgery transvaginal sleeve gastrectomy, including the short-term outcomes and complications. (Surg Obes Relat Dis 2008;4:660 – 663.) © 2008 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Sleeve gastrectomy; Bariatric surgery; Transvaginal; Natural orifice transluminal endoscopic surgery; NOTES
Sleeve gastrectomy (SG) was first described in 1993 by Marceau et al. [1], as the restricted part of a duodenal switch malabsorptive operation, in an attempt to improve the results of biliopancreatic diversion, without performing distal gastrectomy. Recently, sleeve gastrectomy has become a part of the first-step procedure in the superobese patient (body mass index ⬎50 kg/m2) before Roux-en-Y gastric bypass or biliopancreatic diversion with duodenal switch [2–5]. The reason for performing a first-step simple procedure such as SQ in the superobese population before a more complex procedure is to decrease the morbidity and mortality, shorten the operative time, and ease the surgical technique [2]. SG has been also advocated for patients with inflammatory bowel disease, celiac disease, poor intraoperative exposure, profuse visceral fat, a large liver, or cardiopulmonary instability [2]. Early experience has shown that significant weight loss can be obtained by performing SG as a single-stage procedure, even in patients with a low body mass index [6,7]. Laparo-
*Reprint requests: Natan Zundel, M.D., F.A.C.S., 17038 W. Dixie Hwy, Suite 210, Miami Beach, FL 33160. E-mail:
[email protected]
scopic SG has also been advocated as a part of restrictive weight loss surgery for morbid obesity [8 –10]. No long-term experience with laparoscopic SG is available, however, with a maximal follow-up not exceeding 5 years [11]. The natural orifice transluminal endoscopic surgery (NOTES) procedures were first performed in laboratories [12] and on animals [13,14]. Recently, application to humans has been described, including NOTES transgastric and transvaginal cholecystectomy [15–18]. We have gained experience in both laparoscopic SG (⬎300 cases) and NOTES transvaginal cholecystectomy (animal studies [19,20] and ⱕ40 cases in humans [21]). All procedures were performed according to an established protocol, with informed consent and a full explanation to the patient of the experimental nature of the procedure, and with the approval of the local ethics commission. This experience has led to the development of a hybrid NOTES SG procedure using a transvaginal approach to confer the advantages of a lessinvasive procedure to a high-risk population. The possible complications of transvaginal access can be divided into intra- and postoperative. The possible intraoperative complications include bowel perforation, bleeding,
1550-7289/08/$ – see front matter © 2008 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2008.06.009
A. C. Ramos et al. / Surgery for Obesity and Related Diseases 4 (2008) 660 – 663
neurovascular damage of the uterosacral ligament, vaginal tear or laceration, and uterine perforation. The possible postoperative complications include dyspareunia, pelvic abscess, local vaginal infection, and urinary incontinence. A similar approach has already had the access complications defined. It is known in Europe as “fertiloscopy” and in the United States as “hydro-laparoscopy.” Access to the peritoneal cavity is through the vaginal route using a Veress needle puncture in between the uterosacral ligament, followed by saline solution injected into the pelvis and a 3–5-mm blind trocar passage. The complication rates for this procedure have been ⬍.05%. In addition, the SG complications have already been defined by the clinical experience published on laparoscopic SG (rate 0 –24%) and include, but are not limited to, leaks and bleeding. Thus, one should expect similar complications for the transvaginal approach for SG.
661
Fig. 2. Flexible endoscope can be used as camera.
Video/surgical technique description Methods From February to March 2008, 4 women were offered a hybrid NOTES transvaginal SG procedure, after approval by the Central Towers Hospital Ethics Committee (hospital registered under Folio No. 38446 and its Ethics Committee under Folio No. 3878 at the São Paulo Regional Consul of Medicine, which reports to the Brazilian Federal Consul of Medicine). We informed the patients about the experimental nature of this novel approach, our previous experience with laparoscopic SG and laparoscopic transvaginal cholecystectomy using a different protocol, the possible risks and complications of the approach, and the procedure itself. The 4 women were 26, 32, 43, and 46 years old and had a body mass index of 32.1, 45, 39, and 35 kg/m2, respectively. These patients had multiple co-morbidities, including metabolic syndrome and type 2 diabetes.
Fig. 1. Placement of 12-mm trocar through posterior vaginal wall.
The operating room was setup with the video towers to the right of the patient. The patient was placed in the lithotomy position, with the surgeon standing between the patient’s legs. The first assistant stood at the patient’s right side, with the second assistant on the patient’s left side. The pneumoperitoneum was established using a Veress needle at the umbilicus. A 10 –12-mm port was inserted. The pressure was maintained at 10 mm Hg. The patient was placed in the Trendelenburg position to push the small bowel away from the pelvis. Next, under direct visualization, a 12-mm port was inserted transvaginally using the same method as described previously for transvaginal cholecystectomy. Using a hysterometer to elevate the uterus, a long 12-mm trocar was introduced through the posterior vaginal wall between the uterosacral ligaments (Fig. 1). This port should be the optical port. Two types of cameras can be used: a rigid 10-mm scope or a flexible endoscope (Olympus 2T160) (Figs. 2 and 3). The patient was then positioned in the reverse Trendelenburg position, and 2 other ports were placed: a 5-mm port in the right upper quadrant and a 2-mm port in the left upper quadrant (Fig. 4). A window was first created in the gastrocolic ligament close to the stomach and medial to the gastroepiploic vessels, approximately 7 cm proximal to the pylorus. Next, using a harmonic scalpel (Ultracision), the greater curvature of the stomach was freed up to the cardioesophageal junction. Adhesions encountered in the lesser sac were taken down. A 36F orogastric bougie was then placed along the lesser curvature to the pylorus. Using linear staplers, the stomach was divided parallel to the lesser curvature from the mid-antrum to the angle of His. We first used 2 loads of 4.8-mm 60 firings (Echelon) followed by 3.5-mm 60 firings (Fig. 5). The staple line was reinforced with a 3-0 PDS running suture (Fig. 6), and a leak test was performed using methylene blue solution. A Jackson-Pratt drain was placed
662
A. C. Ramos et al. / Surgery for Obesity and Related Diseases 4 (2008) 660 – 663
Fig. 3. Positioning of endoscope.
Fig. 5. Division of stomach with 2 loads of 4.8-mm 60 firings followed by 3.5-mm 60 firings.
along the staple line and was externalized through the 5-mm right upper quadrant port. The stomach was retrieved transvaginally (Fig. 7). The posterior vaginal wall was closed with 3-0 Vicryl suture under direct vision (Fig. 8).
One patient required an extra dose on the second postoperative day. No intraoperative or postoperative complications were identified, and no patient died. These 4 patients were instructed to consume the regular post-SG diet, which consists of a liquid diet for the first 2–3 weeks after surgery, followed by puree and solids in the subsequent weeks. Proton pump inhibitors were prescribed for 8 weeks. The dietary and multidisciplinary follow-up visits were initially scheduled for 5, 15, 30, 60, 90, and 120 days after surgery, then every 3 months for the first year, followed by every 6 months afterward.
Results Our operative time was 90 –100 minutes (mean 95), measured from the placement of the first trocar to removal of the last. All patients underwent surgery and started a clear liquid diet on postoperative day 1. No upper gastrointestinal studies were performed. All patients were discharged home on postoperative day 2. The patients were seen in the office 5 days after surgery when the Jackson-Pratt drain was removed. For pain control, the patients received a nonsteroidal anti-inflammatory drug the morning after the procedure.
Fig. 4. Port positions showing 5-mm port in right upper quadrant and 2-mm port in left upper quadrant. Stapler introduced through 12-mm umbilical port. Camera in place in vaginal port.
Discussion This first experience with human hybrid NOTES transvaginal SG has shown that the procedure seems to be feasible and safe in the short term. However, more studies are necessary to define the reproducibility, efficacy, and cost-effectiveness.
Fig. 6. Staple line reinforced with 3-0 PDS running suture.
A. C. Ramos et al. / Surgery for Obesity and Related Diseases 4 (2008) 660 – 663
663
Appendix Supplementary data The video associated with this article can be found, in the online version, at www.SOARD.org under “Multimedia Library.” References
Fig. 7. Resected stomach retrieved transvaginally.
In the future, improvements are likely to be made that will convert this procedure from a hybrid to total NOTES. These improvements include having a long and flexible stapler that could be passed and positioned along the endoscope to perform the stapling using the vaginal route, avoiding transabdominal ports. Also, endoscopic suture devices or single port access will make possible a “pure” transvaginal NOTES procedure, completely avoiding the need for abdominal ports.
Disclosures A. C. Ramos and M. G. Galvao are consultants to Ethicon Endosurgery. N. Zundel is a consultant to Ethicon Endosurgery and a member of the Bariatric Advisory Board. M. Maalouf claims no commercial associations that might be a conflict of interest in relation to this article.
Fig. 8. Vaginal port closed under direct vision.
[1] Marceau P, Biron S, Bourque RA, Potvin M, Hould FS, Simard S. Biliopancreatic diversion with a new type of gastrectomy. Obes Surg 1993;3:29 –35. [2] Aggarwal S, Kini S, Herron D. Laparoscopic sleeve gastrectomy for morbid obesity: a review. Surg Obes Relat Dis 2007;3:189 –94. [3] Hellins TS. Operative experience and follow-up in a cohort of patients with BMI ⱖ70 kg/m2. Obes Surg 2005;15:482–5. [4] Marceau P, Hould FS, Simard S, et al. Biliopancreatic diversion with duodenal switch. World J Surg 1998;22:947–54. [5] Frezza E. Review Article: Laparoscopic vertical sleeve gastrectomy for morbid obesity: the future of choice? Surg Today 2007;37:275– 81. [6] Baltasar A, Serra C, Perez N, et al. Laparoscopic sleeve gastrectomy: a multi-purpose bariatric operation. Obes Surg 2005;15:1124 – 8. [7] Melissas J, Koukouraki S, Askoxylakis J, et al. Sleeve gastrectomy—a restrictive procedure? Obes Surg 2007;17:57– 62. [8] Roa PE, Kaidar-Person O, Pinto D, et al. Laparoscopic sleeve gastrectomy as treatment for morbid obesity: technique and short-term outcome. Obes Surg 2006;16:1323– 6. [9] Himpens J, Dapri G, Cadiere GB. A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years. Obes Surg 2006;16:1450 – 6. [10] Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc 2007;21:1810–6. [11] American Society for Metabolic and Bariatric Surgery. Position statement on sleeve gastrectomy as a bariatric procedure. Available from: www.asbs.org/Newsite07/resources/sleeve_statement.pdf. Accessed May 14, 2008. [12] Matthew T, Moyer MS, Pauli EM, Haluck RS, Mathew A. A selfapproximating transluminal access technique for potential use in NOTES: an ex vivo porcine model. Gastrointest Endosc 2007;66:974 – 8. [13] Kalloo AN, Singh VK, Jagannath SB, et al. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc 2004;60:114 –7. [14] Park PO, Bergstrom M, Ikeda K, et al. Experimental studies of transgastric gallbladder surgery: cholecystectomy and cholecystogastric anastomosis (videos). Gastrointest Endosc 2005;61:601– 6. [15] Zorron R, Maggioni LC, Pombo L, Oliveira AL, Carvalho GL, Filgueiras M. NOTES transvaginal cholecystectomy: preliminary clinical application. Surg Endosc Epub 2007 Nov 20. [16] Bessler M, Stevens PD, Milone L, Parikh M, Fowler D. Transvaginal laparoscopically assisted endoscopic cholecystectomy: a hybrid approach to natural orifice surgery. Gastrointest Endosc 2007;66:1243–5. [17] Marescaux J, Dallemagne B, Perretta S, Wattiez A, Mutter D, Coumaros D. Surgery without scars: report of transluminal cholecystectomy in a human being. Arch Surg 2007;142:823– 6. [18] Zornig C, Emmermann A, von Waldenfels HA, Mofid H. Laparoscopic cholecystectomy without visible scar: combined transvaginal and transumbilical approach. Endoscopy 2007;39:913–15. [19] Galvao N, Ramos A, Campos J, Moura E, Amaral P. Transgastric salpingectomy in a porcine animal: a NOTES procedure. Surg Endosc 2007;21:S299 –339. [20] Marchesini JC, Ramos AC, Nora M, et al. Hybrid transvaginal sleeve gastrectomy in a porcine model. Surg Endosc 2008;22:S191–293. [21] Ramos A, Galvao NM, Galvao M, et al. Human transvaginal cholecystectomy using a IT-Knife. Surg Endosc 2008;22:S144 –76.
