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Sleeve Gastrectomy + Hiatal Hernia repair group for Acid Reflux

N/A
Waitlist Available
Led By Radu Pescarus, MD
Research Sponsored by Hopital du Sacre-Coeur de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before surgery and 6 months postoperative
Awards & highlights

Study 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.

Eligible Conditions
  • Acid Reflux

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before surgery and 6 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and before surgery and 6 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the presence of pathological Gastroesophageal reflux disease (GERD)
Secondary outcome measures
Presence of hiatal hernia (intrathoracic migration of the sleeve)
Hypotension
Worsening or new-onset gastroesophageal reflux disease

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sleeve Gastrectomy + Hiatal Hernia repair groupExperimental Treatment2 Interventions
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.
Group II: Sleeve Gastrectomy groupActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleeve gastrectomy
2013
Completed Phase 3
~11150

Find a Location

Who is running the clinical trial?

Hopital du Sacre-Coeur de MontrealLead Sponsor
51 Previous Clinical Trials
12,253 Total Patients Enrolled
Radu Pescarus, MDPrincipal InvestigatorHopital Sacré Coeur de Montréal

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Antireflux Efficacy of Hiatal Hernia Repairs in Sleeve Gastrectomy Patients
Radu Pescarus 2019. "Antireflux Efficacy of Hiatal Hernia Repairs in Sleeve Gastrectomy Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04433507.
~3 spots leftby Apr 2025
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