跳至主要内容
临床试验/NCT06316167
NCT06316167招募中不适用

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

Instituto Mexicano del Seguro Social1 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
275
试验地点
1
主要终点
Number of participants without postoperative GERD

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patient records with incomplete information.

结局指标

主要结局

Number of participants without postoperative GERD

时间窗: 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.

次要结局

  • Comorbidities in patients undergoing gastric sleeve with hiatoplasty(6 months)
  • Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty(6 months)
  • Postoperative quality of life analysis(6 months)
  • Comparison of postoperative complication rates, including GERD(6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

GONZALEZ-OJEDA ALEJANDRO

Principal Investigator

Instituto Mexicano del Seguro Social

研究点 (1)

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