Antireflux Efficacy of Hiatal Hernia Repairs Concomitant to Sleeve Gastrectomy in Obese Patients (BMI 35-50)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in the presence of pathological Gastroesophageal reflux disease (GERD)
研究概览
简要总结
Gastroesophageal reflux (GR) occurrence or persistence following a sleeve gastrectomy (SG) can be correlated to several factors but it is clear that one of the key factors is a persistent hiatal hernia or laxity of the esophageal hiatus. However, there are no clear guidelines presently available on surgical management of small size hernias or an abnormal hiatus. Therefore, hiatal hernia management is decided intraoperatively by the operating surgeon. The main goal of this study is to evaluate the efficacy of primary hiatal hernia repairs on gastroesophageal reflux concomitant to sleeve gastrectomy. The secondary objectives are hiatal hernia recurrence following primary surgery and the occurrence of "de novo" GR.
详细描述
Background :
The Sleeve gastrectomy (SG) is the most common bariatric procedure worldwide because it is the simplest to perform, from a technical standpoint, and the most efficient in terms of metabolic control and weight loss. However, this intervention can lead to several complications, including the onset or intensification of gastroesophageal reflux (GR) with the associated impact on the patients' quality of life and a possible evolution into Barrett's esophagus. One of the key factors in the development of this complication is a persistent hiatal hernia.
Aims: The main objective of this study is to provide an objective evaluation of the effect of primary hiatal hernia repair on GR concomitant to sleeve gastrectomy. The secondary objectives are hiatal hernia recurrence following primary surgery and the occurrence of "de novo" GR.
Methods :
A total of 100 patients will be recruited for the pilot study, with 50 patients in the SG group and 50 in the SG + primary hiatal hernia repair group following randomization. Then, based on a sample size study, recruitment will be continued as needed. None of the procedures performed are experimental. All obese patients with a BMI between 35-50, aged 18-65 and undergoing surgery for a SG in the institution's bariatric surgery department will be eligible to participate in this study. Exclusion criteria will be hiatal hernias greater than 2 cm, a hiatal repair requiring a drain, prior bariatric surgery or any other counterindication to SG. All patients will be evaluated preoperatively using: 1) EGD, 2) esophageal manometric study, 3) pH assessment and 4) validated GR questionnaires (GERD-HRPL; GCSI). Iconographic intraoperative data on hiatal morphology and the type of cure used will be collected and records will be kept according to Ethics committee guidelines. After a 6-month follow-up the participants will undergo the same tests, including questionnaires, for a medium-term profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All obese patients with a BMI between 35-50
- •Aged 18-65 and undergoing surgery for a Sleeve Gastrectomy in institution's bariatric surgery department
排除标准
- •hiatal hernias greater than 2 cm,
- •hiatal repair requiring mesh placement
- •prior bariatric surgery or any other counterindication to Sleeve Gastrectomy
结局指标
主要结局
Change in the presence of pathological Gastroesophageal reflux disease (GERD)
时间窗: Before surgery and 6 months after surgery
Pathological GERD will be assessed objectively using a 24 hour pH study and an EGD (esophagogastroduodenoscopy - presence of esophagitis)
次要结局
- Worsening or new-onset gastroesophageal reflux disease(before the surgery and 6 months post-operative)
- Presence of hypotensive lower esophageal sphincter (LES)(before the surgery and 6 months post-operative)
- Presence of hiatal hernia (intrathoracic migration of the sleeve)(Before surgery and 6 months postoperative)
研究者
Radu Pescarus
Principal Investigator
Hopital du Sacre-Coeur de Montreal