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Clinical Trials/NCT07590206
NCT07590206CompletedNot Applicable

Effect of Omentopexy on Incisura Angularis Morphology and Gastric Emptying After Laparoscopic Sleeve Gastrectomy

Ankara University1 site in 1 country36 target enrollmentStarted: June 26, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1

Study Overview

Brief Summary

This prospective randomized study aimed to evaluate the effect of omentopexy performed during laparoscopic sleeve gastrectomy (LSG) on incisura angularis morphology, gastric emptying time, postoperative dyspeptic symptoms, and early weight loss outcomes. Patients undergoing primary LSG were randomized to either LSG with omentopexy or LSG without omentopexy. Gastric emptying was assessed using scintigraphic gastric emptying studies, and changes in incisura angularis angle were evaluated using intraoperative image analysis. Postoperative symptoms were assessed using the Short Form Leeds Dyspepsia Questionnaire.

Detailed Description

Laparoscopic sleeve gastrectomy (LSG) is one of the most commonly performed bariatric surgical procedures worldwide. However, postoperative gastrointestinal symptoms, gastric torsion, and functional stenosis remain important concerns after surgery. Omentopexy has been proposed as a technical modification to stabilize the gastric tube and preserve anatomical alignment, but its clinical and functional effects remain controversial.

This prospective randomized controlled study was conducted to evaluate the effect of omentopexy performed during LSG on incisura angularis morphology, gastric emptying time, postoperative dyspeptic symptoms, and early weight loss outcomes. Eligible patients undergoing primary LSG were randomized into two groups: LSG with omentopexy and LSG without omentopexy.

The incisura angularis angle was evaluated using intraoperative image analysis. Gastric emptying time was assessed preoperatively and at the postoperative third month using scintigraphic gastric emptying studies (T½). Postoperative dyspeptic symptoms were evaluated using the Short Form Leeds Dyspepsia Questionnaire. Demographic, clinical, laboratory, and postoperative outcome data were prospectively recorded and compared between groups.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The researcher performing the incisura angularis angle measurements was blinded to the clinical outcomes and group allocation during image analysis.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients aged between 18 and 65 years Patients scheduled for primary laparoscopic sleeve gastrectomy for obesity treatment Patients who provided written informed consent

Exclusion Criteria

  • Previous gastrointestinal surgery Hiatal hernia Peptic ulcer disease Esophagitis Pangastritis detected on preoperative endoscopy Inability to tolerate postoperative scintigraphic evaluation

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Volkan Genc

Professor of General Surgery

Ankara University

Study Sites (1)

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