Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease

NCT ID: NCT06316167

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-08-31

Brief Summary

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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

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Conditions

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Postgastrectomy Syndromes Gastroesophageal Reflux

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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GONZALEZ-OJEDA ALEJANDRO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Aldo Guzmán-Barba, MD, PhD

Role: STUDY_CHAIR

ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.

Alejandro López-Ortega, MD, PhD

Role: STUDY_DIRECTOR

ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.

Helmut Heribert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.

Isaac Esparza Estrada, MD, PhD

Role: STUDY_CHAIR

ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.

Sergio Jiram Vazquez-Sánchez, MD

Role: STUDY_CHAIR

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

Alejandro González-Ojeda, MD, PhD

Role: STUDY_CHAIR

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

Locations

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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

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Alejandro Gonzalez-Ojeda, MD, PhD

Role: CONTACT

3331294165

Facility Contacts

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Alejandro González-Ojeda, MD, PhD

Role: primary

3331294165

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Hiatoplasty-2024

Identifier Type: -

Identifier Source: org_study_id

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