Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease

Recruiting

• Conditions: Gastroesophageal Reflux; Postgastrectomy Syndromes

• Registration Number: NCT06316167
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

The goal of this observational study is to learn about incidence of postoperative gastroesophageal reflux disease in mandatory hiatoplasty performed during gastric sleeve surgery.

The main question\[s\] it aims to answer are:

* Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty

* Comparison of postoperative complication rates, including GERD

Participants will answer a follow-up questionnaire, about postoperative quality of life

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-07-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• Patients over 18 years of age.
• Gender indistinct.
• Overweight, obesity grade I, II, III, super obesity or super-super obesity.
• Underwent gastric sleeve with hiatoplasty for obesity management at a high volume Tijuana hospital dedicated to bariatric surgery.

Exclusion Criteria

• Patient records with incomplete information.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants without postoperative GERD	6 months	To evaluate the efficacy of mandatory hiatoplasty performed during gastric sleeve surgery in reducing the incidence of postoperative gastroesophageal reflux disease (GERD) in patients undergoing this procedure in a hospital specializing in bariatric surgery in Tijuana, Baja California.

Secondary Outcome Measures

Name	Time	Method
Comorbidities in patients undergoing gastric sleeve with hiatoplasty	6 months	These patients usually have significant obesity, often accompanied by comorbidities such as type 2 diabetes, hypertension, sleep apnea, and gastroesophageal reflux disease (GERD).
Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty	6 months	Hiatoplasty is often performed to reduce the risk of postoperative GERD by repairing a herniated hiatus during gastric sleeve surgery. However, the exact incidence of postoperative GERD can vary and depends on factors such as surgical technique, patient anatomy and postoperative management.
Postoperative quality of life analysis	6 months	Questionnaire postoperative quality of life with the Bariatric Analysis and Reporting Outcome System (BAROS) Questionnaire
Comparison of postoperative complication rates, including GERD	6 months	Postoperative complications may include, but are not limited to, bleeding, infection, sleeve stenosis, and GERD recurrence. Comparison of complication rates between patients with and without mandatory hiatoplasty may provide insight into the effectiveness of this technique in mitigating specific risks.

Trial Locations

Locations (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, Mexico