Comparing Post-Surgical Symptoms: Gastric Sleeve With and Without Omentopexy "Comparing Post-Surgical Symptoms: Gastric Sleeve With and Without Omentopexy" Comparison of Postoperative Symptoms: Gastric Sleeve With and Without Omentopexy.

NCT06396832 | Completed

• 1 other identifier: OMENTOPEXY-2024
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic surgery has proven to be an effective treatment for obesity, with laparoscopic sleeve gastrectomy being the most popular procedure. Omentopexy (OP) is proposed as a strategy to reduce associated complications. Objective was to determine the effectiveness of omentopexy in controlling post-surgical symptoms and to measure the need for re-intervention, leakage, bleeding, and mortality in patients undergoing laparoscopic sleeve gastrectomy.

Conditions

Surgical Procedure, Unspecified

Keywords

Omentopexy; Complications; Metabolic surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative gastrointestinal symptoms

  patients undergoing sleeve gastrectomy with omentopexy for obesity treatment will be lower compared to those undergoing sleeve gastrectomy without adjuncts.

  24 hours

Study Arms (2)

Patients undergoing gastric sleeve surgery with omentopexy

Omentopexy aims to prevent or reverse sleeve gastrectomy complications, but it is not a standardized technique by itself, with more than 5 descriptions of it. Among the authors who have presented their technique are Sharma, Batman, Pilone, Abou Ashour, Nosrati, and Labib. It consists of fixing the remnant stomach with the gastrosplenic and gastrophrenic ligaments to stabilize the posterior aspect of the stomach and prevent gastric torsion, a functional cause of stenosis

Patients undergoing conventional sleeve gastrectomy

The procedure is associated with other complications, some of which are believed to be related to loss of fixation of the stomach to the greater omentum. Among the main ones is nausea, exacerbation or onset of symptoms due to reflux, as well as intolerance to certain foods and regurgitation

Eligibility Criteria

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

Study Population

Patients diagnosed with obesity who underwent sleeve gastrectomy, with or without omentopexy

You may qualify if:

• Diagnosis of obesity
• Adults over 18 years old
• Undergoing sleeve gastrectomy
• Consent to respond to the immediate postoperative symptom questionnaire

You may not qualify if:

• Repair of hiatal hernia
• Refusal to complete the evaluation instrument
• Unavailability of medical records

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico

Guadalajara, Jalisco, 44329, Mexico

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 2, 2024
• Study Start: May 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

ME (1)