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NCT06396832 Clinical Trial

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.

Surgical Procedure, Unspecified Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06396832
Other study ID # OMENTOPEXY-2024
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date April 1, 2024

Study information
Verified date April 2024
Source Instituto Mexicano del Seguro Social
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date April 1, 2024
Est. primary completion date February 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Mexico 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

Sponsors (1)
Lead Sponsor Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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