Antireflux Efficacy of Hiatal Hernia Repairs in Sleeve Gastrectomy Patients

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04433507
• Other study ID #: CER-2019-1642
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2022
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Hernia, Hiatal

Intervention

Procedure:
• Sleeve gastrectomy
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.
• Hiatal Hernia repair
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.

Locations

Country	Name	City	State
Canada	Hopital Sacré-Coeur de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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