Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease

March 11, 2024 updated by: GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social

Implementation of Mandatory Hiatoplasty in Sleeve Gastrectomy: Strategy for Gastro-Esophageal Reflux Disease (GERD) Risk Reduction

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

275

Contacts and Locations

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

Study Contact

  • Name: Alejandro González-Ojeda, MD, PhD
  • Phone Number: 3331294165
  • Email: avygail5@gmail.com

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44329
        • Recruiting
        • 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
        • Contact:

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 over 18 years of age of indistinct gender who underwent gastric sleeve with hiatoplasty for obesity or overweight management in a hospital center specialized in bariatric surgery in Tijuana, Baja California.

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants without postoperative GERD
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comorbidities in patients undergoing gastric sleeve with hiatoplasty
Time Frame: 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).
6 months
Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty
Time Frame: 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.
6 months
Comparison of postoperative complication rates, including GERD
Time Frame: 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.
6 months
Postoperative quality of life analysis
Time Frame: 6 months
Questionnaire postoperative quality of life with the Bariatric Analysis and Reporting Outcome System (BAROS) Questionnaire
6 months

Collaborators and Investigators

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

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Study Chair: José Aldo Guzmán-Barba, MD, PhD, ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
  • Study Director: Alejandro López-Ortega, MD, PhD, ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
  • Principal Investigator: Helmut Heribert, MD, PhD, ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
  • Study Chair: Isaac Esparza Estrada, MD, PhD, ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
  • Study Chair: Sergio Jiram Vazquez-Sánchez, MD, 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
  • Study Chair: Alejandro González-Ojeda, MD, PhD, 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

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)

March 1, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hiatoplasty-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be kept absolutely confidential

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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