A Comparative Study of Staple Line Reinforcement Techniques in Laparoscopic Sleeve Gastrectomy

A Comparative Study of Staple Line Reinforcement Techniques in Laparoscopic Sleeve Gastrectomy : Omentopexy With Plication Versus Titanium Clips

This prospective comparative cohort study was conducted in accordance with the Declaration of Helsinki and approved by the Ethical Committee of the Medical Research Institute. All consecutive patients undergoing laparoscopic sleeve gastrectomy (LSG) between January 2022 and June 2024 in Baghdad were screened for eligibility.

Study Overview

• Status: Completed
• Conditions: Sleeve Gastrectomy; Reinforcement of Staple Line by Titanium Clips; Reinforcement of Staple Line by Suturing, Omentopexy Over Staple Line
• Intervention / Treatment: Other: laprascopic sleeve gastrectomy with omentopexy and suturing; Other: titanium clips

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq
    • Specialist Private Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• BMI more than or equal to 40
• BMI equal or more than 35 with comorbidities

Exclusion Criteria:

• history of previous bariatric procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A: omentopexy; complete staple line invagination using continuous seromuscular suturing with omentopexy	Other: laprascopic sleeve gastrectomy with omentopexy and suturing; reinforcement of staple line by invagination of staple line by seromuscular suturing and omentopexy
Active Comparator: group B : Titanium clips; staple line reinforcement and homeostasis by using titanium clips	Other: titanium clips; titanium clips used for rienforcement and haemostais of staple line in laprascopic sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative leakage	presence of clinical signs (fever , tachycardia ) or radiological evidence of contrast extravasation	up to 6 weeks postoperatively

Collaborators and Investigators

• Sponsor: Al-Kindy Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Sutures
• Other Study ID Numbers: Medical Research Institute

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No