NCT07590206

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 11, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

ObesityLaparoscopic sleeve gastrectomyOmentopexyDyspepsia

Outcome Measures

Primary Outcomes (1)

  • Change in Incisura Angularis Angle

    Changes in the incisura angularis angle were evaluated using vector-based measurements obtained from intraoperative images before and after laparoscopic sleeve gastrectomy.

    Preoperative and postoperative 3 months

Study Arms (2)

LSG With Omentopexy

EXPERIMENTAL

Participants underwent laparoscopic sleeve gastrectomy with omentopexy. Omentopexy was performed by fixation of the greater omentum to the gastric staple line following sleeve gastrectomy.

Procedure: Laparoscopic Sleeve Gastrectomy With Omentopexy

LSG Without Omentopexy

ACTIVE COMPARATOR

Participants underwent standard laparoscopic sleeve gastrectomy without omentopexy.

Procedure: Laparoscopic Sleeve Gastrectomy Without Omentopexy

Interventions

Laparoscopic sleeve gastrectomy was performed using a standard surgical technique. In addition, omentopexy was performed by fixation of the greater omentum to the gastric staple line in order to stabilize the gastric tube anatomy.

LSG With Omentopexy

Standard laparoscopic sleeve gastrectomy was performed without omentopexy.

LSG Without Omentopexy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Medicine

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityOverweightDyspepsia

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Volkan Genç, MD

    Ankara University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The researcher performing the incisura angularis angle measurements was blinded to the clinical outcomes and group allocation during image analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomized in a 1:1 ratio into two parallel groups: laparoscopic sleeve gastrectomy with omentopexy and laparoscopic sleeve gastrectomy without omentopexy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of General Surgery

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 15, 2026

Study Start

June 26, 2023

Primary Completion

December 27, 2024

Study Completion

December 27, 2024

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Locations