Antireflux Efficacy of Hiatal Hernia Repairs in Sleeve Gastrectomy Patients

Study Overview
=================
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.

Official Title
-----------------
Antireflux Efficacy of Hiatal Hernia Repairs Concomitant to Sleeve Gastrectomy in Obese Patients (BMI 35-50)

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Procedure: Sleeve gastrectomy
* Procedure: Hiatal Hernia repair


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 50 patients in the SG group and 50 in the SG + primary hiatal hernia repair group following randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleeve Gastrectomy group<br>This group will receive a Sleeve Gastrectomy only, a mainly restrictive procedure which consists in creating a narrow tube-like stomach based on its lesser curvature. | Procedure: Sleeve gastrectomy<br>* Laparoscopic sleeve gastrectomy (LSG) is performed through a standard 5-port technique. After dissection of the greater curvature of the stomach, a narrow tube-like stomach is created after stapling off the lateral aspect of the stomach using a 40 French bougie as a guide.<br>|
| Experimental: Sleeve Gastrectomy + Hiatal Hernia repair group<br>This group will receive a Sleeve Gastrectomy combined with hiatal hernia repair. Hiatal Hernia repair consists of a peri-esophageal dissection proximal to the diaphragmatic crura to achieve an intra-abdominal esophageal length of 2-3 cm. The pillars will then be closed anteriorly and posteriorly using nonabsorbable sutures. | Procedure: Sleeve gastrectomy<br>* Laparoscopic sleeve gastrectomy (LSG) is performed through a standard 5-port technique. After dissection of the greater curvature of the stomach, a narrow tube-like stomach is created after stapling off the lateral aspect of the stomach using a 40 French bougie as a guide.<br>Procedure: Hiatal Hernia repair<br>* Hiatal hernia repair consists in a circumferential dissection of the diaphragmatic crura to achieve an intra abdominal esophageal length of 2-3 cm. The crura will then be closed anteriorly and posteriorly using nonabsorbable sutures.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the presence of pathological Gastroesophageal reflux disease (GERD) | Pathological GERD will be assessed objectively using a 24 hour pH study and an EGD (esophagogastroduodenoscopy - presence of esophagitis) | Before surgery and 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of hiatal hernia (intrathoracic migration of the sleeve) | Presence of hiatal hernia will be assessed using EGD and high-resolution esophageal manometry | Before surgery and 6 months postoperative | 
| Presence of hypotensive lower esophageal sphincter (LES) | Hypotensive LES will be measured objectively using a high-resolution esophageal manometry study | before the surgery and 6 months post-operative | 
| Worsening or new-onset gastroesophageal reflux disease | Worsening or new-onset gastroesophageal reflux disease will be measured using a validated reflux questionnaire (GERD-HRQL). The GERD-HRQL questionnaire was developed and validated to measure changes of typical GERD symptoms such as heartburn and regurgitation in response to surgical or medical treatment. Total Score: Calculated by summing the individual scores to questions 1-15. Greatest possible score (worst symptoms) = 75 Lowest possible score (no symptoms) = 0 | before the surgery and 6 months post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleeve Gastrectomy, Gastroesophageal reflux, Bariatric Surgery, Complications