Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT06316167
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease
Sponsor:
Instituto Mexicano del Seguro Social
Organization:
Study Overview
Official Title:
Implementation of Mandatory Hiatoplasty in Sleeve Gastrectomy: Strategy for Gastro-Esophageal Reflux Disease (GERD) Risk Reduction
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: