Comparative 3-year Study of Nissen-sleeve vs. Sleeve Plus Cruroplasty in Obese Patients With Hiatal Hernia (HH-N Sleeve)

February 18, 2025 updated by: Elsan

The success of laparoscopic sleeve gastrectomy (LSG) is not only due to its proven efficacy in the treatment of obesity and associated to comorbidities in the short and long term, but also because it is considered as less technically complicated compared to other malabsorptive procedures. Unfortunately, the main long-term side effect of LSG appears to be the development of severe gastroesophageal reflux (GERD). This problem is aggravated by the concomitant presence of a hiatal hernia at the time of surgery. Indeed, by causing laxity of the lower esophageal sphincter (LES), the hiatal hernia reduces the barrier functions of the esophageal-gastric junction against the reflux of gastric contents.

The classic combination of sleeve and hiatal hernia treatment by cruroplasty gives contradictory results and several surgeons prefer to perform only the sleeve without addressing the hiatal hernia especially if it is small (<4 cm). For this reason a modification of the usual surgical technique of LSG has been proposed by adding a Nissen fundoplication-Nissen Sleeve (NS). The intentions of this technique were to minimize the rate of postoperative GERD especially for patients with hiatal hernia, to protect the staple line of the angle of His, and finally to provide a safe and effective alternative for patients with a contraindication to LRYGB due to GERD. Although the first results of the technique are encouraging, the realization of the Nissen valve remains a sensitive technical point that can transform a relatively simple procedure like LSG into a more complex procedure like NS. The only test able to directly identify and classify gastric reflux is pH-metry with or without esophageal manometry. Unfortunately, especially due to the difficulty of access to the examination, there are no studies with solid scientific bases that identify the correct conduct to adopt in the case of an obese patient with a hiatal hernia (with or without preoperative reflux).

The main objective of this study is to evaluate the occurence or worsening of GERD at 3 years following a Nissen-sleeve vs. sleeve plus cruroplasty intervention in patients with obesity and hiatal hernia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient,
  • Patient with severe obesity (BMI >35) with comorbidity or morbidity (BMI >40),
  • Patient awaiting a sleeve gastrectomy,
  • Patient with a hiatal hernia <or= 4 cm,
  • Patient having undergone a gastroscopy,
  • Patient having undergone an esophagogastroduodenal transit (OGDT),
  • Patient having been informed and having given their free, informed and written consent,
  • Patient affiliated with or beneficiary of a social security scheme.

Exclusion Criteria:

  • Patient with poorly controlled diabetes,
  • Patient with major esophageal motility disorders,
  • Patient with a Hiatal Hernia > 4cm,
  • History of bariatric surgery, history of ring,
  • Patient refusing pH-metry examination,
  • Refusal to participate in the study,
  • Patient under legal protection,
  • Patient not benefiting from health protection,
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nissen sleeve surgery
Diagnostic test: Ph-measurement
Ph measurement before and after the surgery
Other: Questionnaires
GERD-HRQL Reflux symptom index scale before and after surgery
Diagnostic test: gastroduodenal transit
Imaging test that uses the properties of X-rays - after the administration of a radiopaque contrast agent (usually barium) - to visualize the upper digestive tract: the esophagus, stomach, and duodenum (the upper segment of the small intestine).
Active Comparator: Sleeve plus cruroplasty
Diagnostic test: Ph-measurement
Ph measurement before and after the surgery
Other: Questionnaires
GERD-HRQL Reflux symptom index scale before and after surgery
Diagnostic test: gastroduodenal transit
Imaging test that uses the properties of X-rays - after the administration of a radiopaque contrast agent (usually barium) - to visualize the upper digestive tract: the esophagus, stomach, and duodenum (the upper segment of the small intestine).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appearance of GERD 3 years after surgery.
Time Frame: 3 years
Occurrence if DeMeester score at 3 years is ≥ 14.72 (<14.72 before surgery) and/or treatment with proton pump inhibitors (PPIs) and/or Reflux Disease Questionnaire score > 10 (≤10 before surgery) and/or GERD-HRQL score > 16 (≤16 before surgery).
3 years
Worsening of GERD 3 years after surgery.
Time Frame: 3 years
Worsening if increase in DeMeester score at 3 years compared to that before the intervention and/or introduction or increase in the dose of PPI compared to that before the intervention and/or increase in the Reflux Disease Questionnaire score at 3 years compared to that before the intervention and/or increase in the GERD-HRQL score at 3 years compared to that before the intervention.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Collaborators

Clinique saint-Michel de Toulon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2025

Primary Completion (Estimated)

November 2, 2028

Study Completion (Estimated)

November 2, 2031

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A00367-40

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Ph-measurement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe