Short Term Outcome Of Distal Mesogastric Fixation After Laparoscopic Sleeve Gastrectomy;

NCT04834323 | Completed

• 1 other identifier: Said Negm
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study included patients who were admitted to investigator's center to do laparoscopic sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020. Sample size was 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation.

Conditions

Bariatric Surgery Candidate

Keywords

Laparoscopic Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (2)

• Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of Axial gastric rotation.

  Incidence of Axial gastric rotation after the operation

  Within one week after the operation

• Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of gastric leakage .

  Percentage of patients developed gastric leakage after the operation

  Within one week after the operation

Secondary Outcomes (1)

• Quality of life after distal mesogasric fixation after laparoscopic sleeve gastrectomy

  Within one month after the operation

Study Arms (2)

group (1)

ACTIVE COMPARATOR

included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy

Procedure: distal mesogastric fixation after sleeve gastrectomy

group (2)

NO INTERVENTION

included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation

Interventions

distal mesogastric fixation after sleeve gastrectomy PROCEDURE

Investigators performed traditional laparoscopic sleeve gastrectomy then we fixed the greater omentum \& mesocolon that were cut during gastrectomy to the remaining gstric pouch along the new greater curvature as high as possible along the stable line then we plicated the remaining staple line till angle of His. (the greater omentum \& mesocolon not reach this part of staple line) , so the remaining gastric pouch remained tension free and was returned to original position and this may prevent the axial gastric rotation

group (1)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who had no contraindication for laparoscopic surgery.
• patients with good general condition with American society of anesthesiology (ASA) I \& II.
• patients with body mass index above 35 were included.

You may not qualify if:

• patients who had bad general condition (ASA ≥3). 2- patients with gastro esophageal reflux or hiatal hernia.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqua, 1185, Egypt

Location

Related Publications (9)

• Angrisani L, Santonicola A, Iovino P, Vitiello A, Higa K, Himpens J, Buchwald H, Scopinaro N. IFSO Worldwide Survey 2016: Primary, Endoluminal, and Revisional Procedures. Obes Surg. 2018 Dec;28(12):3783-3794. doi: 10.1007/s11695-018-3450-2.

  PMID: 30121858 BACKGROUND

• Benedix F, Poranzke O, Adolf D, Wolff S, Lippert H, Arend J, Manger T, Stroh C; Obesity Surgery Working Group Competence Network Obesity. Staple Line Leak After Primary Sleeve Gastrectomy-Risk Factors and Mid-term Results: Do Patients Still Benefit from the Weight Loss Procedure? Obes Surg. 2017 Jul;27(7):1780-1788. doi: 10.1007/s11695-017-2543-7.

  PMID: 28078641 BACKGROUND

• Abou Rached A, Basile M, El Masri H. Gastric leaks post sleeve gastrectomy: review of its prevention and management. World J Gastroenterol. 2014 Oct 14;20(38):13904-10. doi: 10.3748/wjg.v20.i38.13904.

  PMID: 25320526 BACKGROUND

• Gagner M. Decreased incidence of leaks after sleeve gastrectomy and improved treatments. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):611-2. doi: 10.1016/j.soard.2014.04.002. Epub 2014 Apr 14. No abstract available.

  PMID: 25224165 BACKGROUND

• Nimeri A, Ibrahim M, Maasher A, Al Hadad M. Management Algorithm for Leaks Following Laparoscopic Sleeve Gastrectomy. Obes Surg. 2016 Jan;26(1):21-5. doi: 10.1007/s11695-015-1751-2.

  PMID: 26071239 BACKGROUND

• Alizadeh RF, Li S, Inaba C, Penalosa P, Hinojosa MW, Smith BR, Stamos MJ, Nguyen NT. Risk Factors for Gastrointestinal Leak after Bariatric Surgery: MBASQIP Analysis. J Am Coll Surg. 2018 Jul;227(1):135-141. doi: 10.1016/j.jamcollsurg.2018.03.030. Epub 2018 Mar 30.

  PMID: 29605723 BACKGROUND

• Parikh M, Issa R, McCrillis A, Saunders JK, Ude-Welcome A, Gagner M. Surgical strategies that may decrease leak after laparoscopic sleeve gastrectomy: a systematic review and meta-analysis of 9991 cases. Ann Surg. 2013 Feb;257(2):231-7. doi: 10.1097/SLA.0b013e31826cc714.

  PMID: 23023201 BACKGROUND

• Al-Sabah S, Ladouceur M, Christou N. Anastomotic leaks after bariatric surgery: it is the host response that matters. Surg Obes Relat Dis. 2008 Mar-Apr;4(2):152-7; discussion 157-8. doi: 10.1016/j.soard.2007.12.010. Epub 2008 Mar 4.

  PMID: 18294924 BACKGROUND

• Negm S, Amin M, Shafiq A, Atef B, Yassin M, Farag A. The short-term outcome of distal mesogastric fixation after laparoscopic sleeve gastrectomy: a randomized controlled trial. Surg Today. 2022 Mar;52(3):510-513. doi: 10.1007/s00595-022-02459-x. Epub 2022 Jan 31.

  PMID: 35099602 DERIVED

Study Officials

• Said Mohamed Negm, MD

  ZAGAZIG UNIVERSITY HOSPITALS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of general surgery

Model Details: This study included patients who were admitted to our center to do laparoscopic sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020. Sample size was 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation.

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 8, 2021
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)