Clinical trial NCT06316167: Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease
Official title: Implementation of Mandatory Hiatoplasty in Sleeve Gastrectomy: Strategy for Gastro-Esophageal Reflux Disease (GERD) Risk Reduction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postgastrectomy Syndromes
Gastroesophageal Reflux
Keywords: Incidence
Complications
Bariatric surgery
Obesity
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-03-18
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants without postoperative GERD
timeFrame: 6 months
Secondary outcomes:
measure: Comorbidities in patients undergoing gastric sleeve with hiatoplasty
timeFrame: 6 months
measure: Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty
timeFrame: 6 months
measure: Comparison of postoperative complication rates, including GERD
timeFrame: 6 months
measure: Postoperative quality of life analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: 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
state: Jalisco
Study officials:
affiliation: ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
name: José Aldo Guzmán-Barba, MD, PhD
role: STUDY_CHAIR
affiliation: ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
name: Alejandro López-Ortega, MD, PhD
role: STUDY_DIRECTOR
affiliation: ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
name: Helmut Heribert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
name: Isaac Esparza Estrada, MD, PhD
role: STUDY_CHAIR
affiliation: 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
name: Sergio Jiram Vazquez-Sánchez, MD
role: STUDY_CHAIR
affiliation: 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
name: Alejandro González-Ojeda, MD, PhD
role: STUDY_CHAIR
References: