Comparison of Laparoscopic Traditional and Knotless Sutures

NCT02720718 | Completed DMC

• 1 other identifier: Strat-001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background Excess weight and obesity is the fifth leading risk factor for global death. Bariatric surgery is considered as the only effective long-term treatment for morbid obesity. Laparoscopic Roux-en-Y gastric bypass is one of the best surgical procedures, since it achieves excellent long-term results with a low complication rate. Intestinal anastomosis is a very complex and time-consuming procedure in laparoscopy, mainly due to the difficulties of knotting the suture in a limited working area. Barbed sutures may enhance this procedure by eliminating the need for knot tying. Objective The aim of this study is to compare the safety and efficacy of knotless barbed sutures (Stratafix) and continuous sutures (Vicryl) for closing the gastrojejunal and jejunojejunal anastomosis in obese patients undergoing gastric bypass. Study design This is a prospective randomized study. Patients will be randomly assigned to one of two groups: traditional suture group or knotless suture group. Randomization will be realized by sealed envelopes according to a computer-generated sequence of random numbers, which will be opened for the surgeon just before starting the anastomosis. During the surgery the gastrojejunal and jejunojejunal anastomoses will be performed with a stapler (Echelon 45 Endopath) and closed with a traditional (Vicryl) or knotless (Stratafix Unidirectional) suture. The same surgeon, experienced and specialized in laparoscopic gastric bypass technique, will perform all procedures. Study population Two hundred patients undergoing laparoscopic Roux-en-Y gastric bypass. Main study parameters/endpoints The primary outcome measure will be the rate of anastomosis-related complications (leakage, bleeding, gastric fistula, anastomotic stenosis) at 4 weeks and at 6 months post-op (safety). The secondary outcome measure will be the time spent on closing the gastrojejunal and jejunojejunal anastomosis (efficacy).

Conditions

Anastomosis, Roux-en-Y; Surgical Operation With Anastomosis, Bypass or Graft

Keywords

Gastric Bypass Status for Obesity Complicating Pregnancy, Childbirth and the Puerperium; Laparoscopy; Suture Techniques; Sutures

Outcome Measures

Primary Outcomes (1)

• Complication rate.

  Complications encountered postoperatively: leakage, stenosis, bleeding and gastric fistula.

  Up until 6 months after surgery.

Secondary Outcomes (4)

• Length of hospital stay.

  Through study completion, an average of 3 days.

• Total procedure time.

  intraoperative

• Jejunojejunal anastomosis time.

  intraoperative

• Gastrojejunal anastomosis time.

  intraoperative

Study Arms (2)

Stratafix

EXPERIMENTAL

Patients undergoing laparoscopic RYGB (antecolic, antegastric, "linear anastomosis-technique") using unidirectional barbed (knotless) sutures: Stratafix Unidirectional 2/0.

Device: Stratafix

Vicryl

ACTIVE COMPARATOR

Patients undergoing laparoscopic RYGB (antecolic, antegastric, "linear anastomosis-technique") using classic sutures: Vicryl 2/0.

Device: Vicryl

Interventions

Stratafix DEVICE

Stratafix

Vicryl DEVICE

Vicryl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• BMI \> 40 (morbid obesity) or BMI \> 35 with co-morbidities (type 2 diabetes, proven sleep apnoea and/or refractory arterial hypertension)
• Reasonable attempts at other weight loss techniques
• Obesity related health problems
• No psychiatric or drug dependency problems
• Capable to understand the risks and commitment associated with the surgery
• Pregnancy not anticipated in the first two years following surgery

You may not qualify if:

• No agreement to informed consent

Sponsors & Collaborators

• AZ St.-Dimpna Geel: lead

Related Publications (10)

• Costantino F, Dente M, Perrin P, Sarhan FA, Keller P. Barbed unidirectional V-Loc 180 suture in laparoscopic Roux-en-Y gastric bypass: a study comparing unidirectional barbed monofilament and multifilament absorbable suture. Surg Endosc. 2013 Oct;27(10):3846-51. doi: 10.1007/s00464-013-2993-5. Epub 2013 May 31.

  PMID: 23722892 BACKGROUND

• De Blasi V, Facy O, Goergen M, Poulain V, De Magistris L, Azagra JS. Barbed versus usual suture for closure of the gastrojejunal anastomosis in laparoscopic gastric bypass: a comparative trial. Obes Surg. 2013 Jan;23(1):60-3. doi: 10.1007/s11695-012-0763-4.

  PMID: 22968833 BACKGROUND

• Facy O, De Blasi V, Goergen M, Arru L, De Magistris L, Azagra JS. Laparoscopic gastrointestinal anastomoses using knotless barbed sutures are safe and reproducible: a single-center experience with 201 patients. Surg Endosc. 2013 Oct;27(10):3841-5. doi: 10.1007/s00464-013-2992-6. Epub 2013 May 14.

  PMID: 23670743 BACKGROUND

• Fisher BL, Schauer P. Medical and surgical options in the treatment of severe obesity. Am J Surg. 2002 Dec;184(6B):9S-16S. doi: 10.1016/s0002-9610(02)01173-x.

  PMID: 12527344 BACKGROUND

• Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.

  PMID: 12365955 BACKGROUND

• Gonzalez R, Lin E, Venkatesh KR, Bowers SP, Smith CD. Gastrojejunostomy during laparoscopic gastric bypass: analysis of 3 techniques. Arch Surg. 2003 Feb;138(2):181-4. doi: 10.1001/archsurg.138.2.181.

  PMID: 12578417 BACKGROUND

• Milone M, Di Minno MN, Galloro G, Maietta P, Bianco P, Milone F, Musella M. Safety and efficacy of barbed suture for gastrointestinal suture: a prospective and randomized study on obese patients undergoing gastric bypass. J Laparoendosc Adv Surg Tech A. 2013 Sep;23(9):756-9. doi: 10.1089/lap.2013.0030. Epub 2013 Jul 16.

  PMID: 23859743 BACKGROUND

• Schauer PR, Burguera B, Ikramuddin S, Cottam D, Gourash W, Hamad G, Eid GM, Mattar S, Ramanathan R, Barinas-Mitchel E, Rao RH, Kuller L, Kelley D. Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus. Ann Surg. 2003 Oct;238(4):467-84; discussion 84-5. doi: 10.1097/01.sla.0000089851.41115.1b.

  PMID: 14530719 BACKGROUND

• Suter M, Donadini A, Romy S, Demartines N, Giusti V. Laparoscopic Roux-en-Y gastric bypass: significant long-term weight loss, improvement of obesity-related comorbidities and quality of life. Ann Surg. 2011 Aug;254(2):267-73. doi: 10.1097/SLA.0b013e3182263b66.

  PMID: 21772127 BACKGROUND

• Gys B, Gys T, Lafullarde T. The Use of Unidirectional Knotless Barbed Suture for Enterotomy Closure in Roux-en-Y Gastric Bypass: a Randomized Comparative Study. Obes Surg. 2017 Aug;27(8):2159-2163. doi: 10.1007/s11695-017-2628-3.

  PMID: 28281235 DERIVED

Related Links

• World Health Organization. Fact sheet number 311. 2011.

Study Officials

• Ben Gys, md

  AZ Sint Dimpna, Geel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 28, 2016
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 3, 2017

Record last verified: 2017-02