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.

April 30, 2024 updated by: GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social

POST-SURGICAL SYMPTOMS IN PATIENTS UNDERGOING GASTRIC SLEEVE SURGERY: OMENTOPEXY VS. NO OMENTOPEXY

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients who underwent laparoscopic sleeve gastrectomy (LSG). Of these patients, 53 received LSG with omentopexy (OP) and 52 underwent LSG without omentopexy (NO OP) between 2022 and 2023. Each group was attended by a different surgeon. The analysis focused on data concerning gastrointestinal symptoms recorded 24 hours postoperatively, as well as documented cases of bleeding, leakage, re-operation, and mortality during the hospitalization period

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44329
        • 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, México

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative gastrointestinal symptoms
Time Frame: 24 hours
patients undergoing sleeve gastrectomy with omentopexy for obesity treatment will be lower compared to those undergoing sleeve gastrectomy without adjuncts.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMENTOPEXY-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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