Comparison of Omentopexy and Clips on the Staple Line During Laparoscopic Sleeve Gastrectomy

NCT06219668 | Completed

• 1 other identifier: Clips - Omentopexy
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Bleeding through the staple line has been reported as one of the most common staple-related complications in laparoscopic sleeve gastrectomy (LSG). In this study, we aimed to compare the effects of clips and omentopexy techniques on postoperative bleeding and readmissions during the first 30-days following surgery. Methods: In this prospective randomized controlled study, patients were divided into two groups: clips group and omentopexy group. The groups were compared in terms of postoperative decrease in hemoglobin and hematocrit values, preoperative and peroperative blood pressure values, duration of surgery, number of patients requiring erythrocyte suspension (ES) transfusion, length of hospital stay, hospital readmissions in the first 30-days postoperatively and early postoperative complications.

Conditions

Compassion; Bleeding; Nausea, Postoperative; Readmission

Keywords

Bariatric Surgery; clips versus omentopexy; postoperative outcomes

Outcome Measures

Primary Outcomes (1)

• Bleeding rates

  comparison of groups in terms of bleeding rates in postoperative process

  3 months

Secondary Outcomes (1)

• Hospital readmission rates

  3 months

Study Arms (2)

omentopexy with LSG

ACTIVE COMPARATOR

We performed omentopexy on staple line after LSG

Procedure: Omentopexy group

Clips with LSG

ACTIVE COMPARATOR

we performed Clips on staple line after LSG

Procedure: Omentopexy group

Interventions

Omentopexy group PROCEDURE

Omentopexy and Clips on staple line during LSG

Also known as: Clips group

Clips with LSG; omentopexy with LSG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• performed Laparoscopic sleeve gastrectomy,
• consent to participate in the study

You may not qualify if:

• performed other bariatric procedures,
• uncontrolled hypertension,
• have a gastroesophageal reflux

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34764, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemorrhage; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: August 15, 2023
• Primary Completion: January 10, 2024
• Study Completion: February 10, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR

Locations

TU (1)