NCT07565038

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

  • incidence of postoperative leakage

    presence of clinical signs (fever , tachycardia ) or radiological evidence of contrast extravasation

    up to 6 weeks postoperatively

Study Arms (2)

group A: omentopexy

ACTIVE COMPARATOR

complete staple line invagination using continuous seromuscular suturing with omentopexy

Other: laprascopic sleeve gastrectomy with omentopexy and suturing

group B : Titanium clips

ACTIVE COMPARATOR

staple line reinforcement and homeostasis by using titanium clips

Other: titanium clips

Interventions

laprascopic sleeve gastrectomy with omentopexy and suturingOTHER

reinforcement of staple line by invagination of staple line by seromuscular suturing and omentopexy

group A: omentopexy
titanium clipsOTHER

titanium clips used for rienforcement and haemostais of staple line in laprascopic sleeve gastrectomy

group B : Titanium clips

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • history of previous bariatric procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Specialist Private Hospital

Baghdad, Iraq

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: cohort
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist in general and laprascopic surgey

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start

January 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

IR(1)