Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06316167

Enrollment

275

Registered

2024-03-18

Start date

2024-03-01

Completion date

2024-08-31

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux, Postgastrectomy Syndromes

Keywords

Incidence, Complications, Bariatric surgery, Obesity

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of participants without postoperative GERD	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.

Secondary

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

Countries

Mexico

Contacts

Primary ContactAlejandro Gonzalez-Ojeda, MD, PhD

avygail5@gmail.com3331294165

Outcome results