Omentopexy with Glubran®2 for reducing complications after laparoscopic sleeve gastrectomy: results of a randomized controlled study

Vincenzo Pilone, Salvatore Tramontano, Michele Renzulli, Mafalda Romano, Angela Monda, Alice Albanese, Mirto Foletto, Vincenzo Pilone, Salvatore Tramontano, Michele Renzulli, Mafalda Romano, Angela Monda, Alice Albanese, Mirto Foletto

Abstract

Background: Gastric fistulas, bleeding, and strictures are commonly reported after laparoscopic sleeve gastrectomy (LSG), that increase morbidity and hospital stay and may put the patient's life at risk. We report our prospective evaluation of application of synthetic sealant, a modified cyanoacrylate (Glubran®2), on suture rime, associated with omentopexy, to identify results on LSG-related complications.

Methods: Patients were enrolled for LSG by two Bariatric Centers, with high-level activity volume. Intraoperative recorded parameters were: operative time, estimated intraoperative bleeding, conversion rate. We prospectively evaluated the presence of early complications after LSG during the follow up period. Overall complications were analyzed. Perioperative data and weight loss were also evaluated. A control group was identified for the study.

Results: Group A (treated with omentopexy with Glubran®2) included 96 cases. Control group included 90 consecutive patients. There were no differences among group in terms of age, sex and Body Mass Index (BMI). No patient was lost to follow-up for both groups. Overall complication rate was significantly reduced in Group A. Mean operative time and estimated bleeding did not differ from control group. We observed three postoperative leaks in Group B, while no case in Group A (not statistical significancy). We did not observe any mortality, neither reoperation. Weight loss of the cohort was similar among groups. In our series, no leaks occurred applying omentopexy with Glubran®2.

Conclusion: Our experience of omentopexy with a modified cyanoacrylate sealant may lead to a standardized and reproducible approach that can be safeguard for long LSG-suture rime.

Trial registration: Retrospective registration on clinicaltrials.gov PRS, with TRN NCT03833232 (14/02/2019).

Keywords: Gastric fistula; Leak; Omentopexy; Sealant; Sleeve gastrectomy.

Conflict of interest statement

All authors declare that they have no conflict of interest, nor financial and non-financial competing interests related to study.

Figures

Fig. 1
Fig. 1
weight loss related to follow-up

References

    1. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2005;292(14):1724–1737. doi: 10.1001/jama.292.14.1724.
    1. Sjöström L. Review of the key results from the Swedish Obese Subjects (SOS) trial - a prospective controlled intervention study of bariatric surgery. J Intern Med. 2013;273(3):219–234. doi: 10.1111/joim.12012.
    1. Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014;8(8):CD003641.
    1. Clinical IssuesCommittee of the AmericanSociety for Metabolic and Bariatric Surgery Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2010;6(1):1–5. doi: 10.1016/j.soard.2009.11.004.
    1. van Rutte PW, Smulders JF, de Zoete JP, Nienhuijs SW. Outcome of sleeve gastrectomy as a primary bariatric procedure. Br J SurgMay. 2014;101(6):661–668. doi: 10.1002/bjs.9447.
    1. Himpens J, Dobbeleir J, Peeters G. Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg. 2010;252(2):319–324. doi: 10.1097/SLA.0b013e3181e90b31.
    1. Varban OA, Greenberg CC, Schram J, Ghaferi AA, Thumma JR, Carlin AM, Dimick JB, Michigan Bariatric Surgery Collaborative Surgical skill in bariatric surgery: Does skill in one procedure predict outcomes for another? Surgery. 2016;160(5):1172–1181. doi: 10.1016/j.surg.2016.04.033.
    1. Arman GA, Himpens J, Dhaenens J, Ballet T, Vilallonga R, Leman G. Long-term (11+years) outcomes in weight, patient satisfaction, comorbidities, and gastroesophageal reflux treatment after laparoscopic sleeve gastrectomy. Surg Obes Relat Dis. 2016;12(10):1778–1786. doi: 10.1016/j.soard.2016.01.013.
    1. Fried M, Yumuk V, Oppert JM, Scopinaro N, Torres A, Weiner R, Yashkov Y, Frühbeck G, International Federation for Surgery of Obesity and Metabolic Disorders-European Chapter (IFSO-EC); European Association for the Study of Obesity (EASO); European Association for the Study of Obesity Obesity Management Task Force (EASO OMTF) Interdisciplinary European guidelines on metabolic and bariatric surgery. Obes Surg. 2014;24(1):42–55. doi: 10.1007/s11695-013-1079-8.
    1. Hayes K, Eid G. Laparoscopic sleeve gastrectomy, surgical technique and perioperative care. Surg Clin North Am. 2016;96(4):763–771. doi: 10.1016/j.suc.2016.03.015.
    1. Rosenthal RJ, International Sleeve Gastrectomy Expert Panel. Diaz AA, Arvidsson D, Baker RS, Basso N, Bellanger D, Boza C, El Mourad H, France M, Gagner M, Galvao-Neto M, Higa KD, Himpens J, Hutchinson CM, Jacobs M, Jorgensen JO, Jossart G, Lakdawala M, Nguyen NT, Nocca D, Prager G, Pomp A, Ramos AC, Rosenthal RJ, Shah S, Vix M, Wittgrove A, Zundel N. International Sleeve Gastrectomy Expert Panel Consensus Statement: best practice guidelines based on experience of >12,000 cases. Surg Obes Relat Dis. 2012;8(1):8–19. doi: 10.1016/j.soard.2011.10.019.
    1. Osland E, Yunus RM, Khan S, Alodat T, Memon B, Memon MA. Postoperative Early Major and Minor Complications in Laparoscopic Vertical Sleeve Gastrectomy (LVSG) Versus Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) Procedures: A Meta-Analysis and Systematic Review. Obes Surg. 2016;26(10):2273–2284. doi: 10.1007/s11695-016-2101-8.
    1. Gagner M, Hutchinson C, Rosenthal R. Fifth International Consensus Conference: current status of sleeve gastrectomy. Surg Obes Relat Dis. 2016;12(4):750–756. doi: 10.1016/j.soard.2016.01.022.
    1. El-Sayes IA, Frenken M, Weiner RA. Management of leakage and stenosis after sleeve gastrectomy. Surgery. 2017;162(3):652–661. doi: 10.1016/j.surg.2017.04.015.
    1. Sakran N, Goitein D, Raziel A, Keidar A, Beglaibter N, Grinbaum R, Matter I, Alfici R, Mahajna A, Waksman I, Shimonov M, Assalia A. Gastric leaks after sleeve gastrectomy: a multicenter experience with 2,834 patients. SurgEndosc. 2013;27(1):240–245.
    1. Deitel M, Gagner M, Erickson AL, Crosby RD. Third International Summit: Current status of sleeve gastrectomy. SurgObesRelat Dis. 2011;7(6):749–759.
    1. Aurora AR, Khaitan L, Saber AA. Sleeve gastrectomy and the risk of leak: a systematic analysis of 4,888 patients. Surg Endosc. 2012;26(6):1509–1515. doi: 10.1007/s00464-011-2085-3.
    1. Musella M, Milone M, Maietta P, Bianco P, Pisapia A, Gaudioso D. Laparoscopic sleeve gastrectomy: efficacy of fibrin sealant in reducing postoperative bleeding. A randomized controlled trial. Updates Surg. 2014;66(3):197–201. doi: 10.1007/s13304-014-0257-0.
    1. Carandina S, Tabbara M, Bossi M, Valenti A, Polliand C, Genser L, Barrat C. Staple Line Reinforcement During Laparoscopic Sleeve Gastrectomy: Absorbable Monofilament, Barbed Suture, Fibrin Glue, or Nothing? Results of a Prospective Randomized Study. J GastrointestSurg. 2016;20(2):361–366. doi: 10.1007/s11605-015-2999-5.
    1. D'Ugo S, Gentileschi P, Benavoli D, Cerci M, Gaspari A, Berta RD, Moretto C, Bellini R, Basso N, Casella G, Soricelli E, Cutolo P, Formisano G, Angrisani L, Anselmino M. Comparative use of different techniques for leak and bleeding prevention during laparoscopic sleeve gastrectomy: a multicenter study. SurgObesRelat Dis. 2014;10(3):450–454. doi: 10.1016/j.soard.2013.10.018.
    1. Gagner M, Buchwald JN. Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. SurgObes Relat Dis. 2014;10(4):713–723. doi: 10.1016/j.soard.2014.01.016.
    1. Taha O, Abdelaal M, Talaat M, Abozeid M. A Randomized Comparison Between Staple-Line Oversewing Versus No Reinforcement During Laparoscopic Vertical Sleeve Gastrectomy. Obes Surg. 2017;28(1):218–25. doi: 10.1007/s11695-017-2835-y.
    1. MacFayden BV, Jr, Wolfe BM, McKernan JB. Laparoscopic management of the acute abdomen, appendix, and small and large bowel. SurgClin North Am. 1992;72(5):1169–1183. doi: 10.1016/S0039-6109(16)45839-1.
    1. Levashev YN, Akopov AL, Mosin IV. The possibilities of greater omentum usage in thoracic surgery. Eur J CardiothoracSurg. 1999;15(4):465–468. doi: 10.1016/S1010-7940(99)00041-X.
    1. Afaneh C, Costa R, Pomp A, Dakin G. A prospective randomized controlled trial assessing the efficacy of omentopexy during laparoscopic sleeve gastrectomy in reducing postoperative gastrointestinal symptoms. SurgEndosc. 2015;29(1):41–47.
    1. Greenbaum DF, Wasser SH, Riley T, Juengert T, Hubler J, Angel K. Duodenal switch with omentopexy and feeding jejunostomy-a safe and effective revisional operation for failed previous weight loss surgery. Surg Obes Relat Dis. 2011;7(2):213–218. doi: 10.1016/j.soard.2010.10.015.
    1. Martines G, Digennaro R, De Fazio M, Capuano P. Cyanoacrylate sealant compared to fibrin glue in staple line reinforcement during laparoscopic sleeve gastrectomy. Pilot prospective observational study. G Chir. 2017;38(1):50–52. doi: 10.11138/gchir/2017.38.1.050.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel