Examining the effects of hiatoplasty during gastric sleeve surgery on reflux disease
Implementation of Mandatory Hiatoplasty in Sleeve Gastrectomy: Strategy for Gastro-Esophageal Reflux Disease (GERD) Risk Reduction
This study is testing if fixing a certain part of the stomach during gastric sleeve surgery can help prevent reflux problems in patients after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 275 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Mexicano del Seguro Social Government |
| Locations | 1 site (Guadalajara, Jalisco) |
| Trial ID | NCT06316167 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the incidence of postoperative gastroesophageal reflux disease (GERD) in patients who undergo mandatory hiatoplasty during gastric sleeve surgery. It will compare the rates of postoperative complications, including GERD, and assess the quality of life of participants through follow-up questionnaires. The study focuses on patients treated at a high-volume bariatric surgery hospital in Tijuana, Mexico.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with varying degrees of obesity who have undergone gastric sleeve surgery with hiatoplasty.
Not a fit: Patients with incomplete medical records will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into reducing the incidence of GERD in patients undergoing gastric sleeve surgery.
How similar studies have performed: While similar studies have explored postoperative complications in bariatric surgery, the specific focus on mandatory hiatoplasty during gastric sleeve surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guadalajara, Jalisco
- 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 (Recruiting)
Study contacts
- Principal investigator: Helmut Heribert, MD, PhD — ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
- Study coordinator: Alejandro Gonzalez-Ojeda, MD, PhD
- Email: avygail5@gmail.com
- Phone: 3331294165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.