Antireflux Efficacy of Hiatal Hernia Repairs in Sleeve Gastrectomy Patients

NCT04433507 | Terminated

• 1 other identifier: CER-2019-1642
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Keywords

Sleeve Gastrectomy; Gastroesophageal reflux; Bariatric Surgery; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Presence of hiatal hernia (intrathoracic migration of the sleeve)

  Before surgery and 6 months postoperative

• Presence of hypotensive lower esophageal sphincter (LES)

  before the surgery and 6 months post-operative

• Worsening or new-onset gastroesophageal reflux disease

  before the surgery and 6 months post-operative

Study Arms (2)

Sleeve Gastrectomy group

ACTIVE COMPARATOR

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

Sleeve Gastrectomy + Hiatal Hernia repair group

EXPERIMENTAL

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; Procedure: Hiatal Hernia repair

Interventions

Sleeve gastrectomy PROCEDURE

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.

Sleeve Gastrectomy + Hiatal Hernia repair group; Sleeve Gastrectomy group

Hiatal Hernia repair PROCEDURE

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.

Sleeve Gastrectomy + Hiatal Hernia repair group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

Study Sites (1)

Hopital Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Radu Pescarus, MD

  Hopital Sacré Coeur de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 50 patients in the SG group and 50 in the SG + primary hiatal hernia repair group following randomization

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 16, 2020
• Study Start: April 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)