Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06316167
• Other study ID #: Hiatoplasty-2024
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Instituto Mexicano del Seguro Social
• Contact: Alejandro Gonzalez-Ojeda, MD, PhD
• Phone: 3331294165
• Email: avygail5[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux

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	Number of participants without postoperative GERD	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	Comorbidities in patients undergoing gastric sleeve with hiatoplasty	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
Secondary	Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty	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
Secondary	Comparison of postoperative complication rates, including GERD	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
Secondary	Postoperative quality of life analysis	Questionnaire postoperative quality of life with the Bariatric Analysis and Reporting Outcome System (BAROS) Questionnaire	6 months