Clinical trial NCT04433507: Antireflux Efficacy of Hiatal Hernia Repairs in Sleeve Gastrectomy Patients
Official title: Antireflux Efficacy of Hiatal Hernia Repairs Concomitant to Sleeve Gastrectomy in Obese Patients (BMI 35-50)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: Sleeve Gastrectomy
Gastroesophageal reflux
Bariatric Surgery
Complications
Lead sponsor: Hopital du Sacre-Coeur de Montreal
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 50 patients in the SG group and 50 in the SG + primary hiatal hernia repair group following randomization
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* hiatal hernias greater than 2 cm,
* hiatal repair requiring mesh placement
* prior bariatric surgery or any other counterindication to Sleeve Gastrectomy

Primary outcomes:
measure: Change in the presence of pathological Gastroesophageal reflux disease (GERD)
timeFrame: Before surgery and 6 months after surgery
Secondary outcomes:
measure: Presence of hiatal hernia (intrathoracic migration of the sleeve)
timeFrame: Before surgery and 6 months postoperative
measure: Presence of hypotensive lower esophageal sphincter (LES)
timeFrame: before the surgery and 6 months post-operative
measure: Worsening or new-onset gastroesophageal reflux disease
timeFrame: before the surgery and 6 months post-operative
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hopital Sacré-Coeur de Montréal
state: Quebec
Study officials:
affiliation: Hopital Sacré Coeur de Montréal
name: Radu Pescarus, MD
role: PRINCIPAL_INVESTIGATOR
References: