NCT06835790: HH-N Sleeve

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

Not yet recruiting NA Last updated 19 February 2025

What this trial tests

NA trial testing Ph-measurement in Obesity in 150 participants. Not yet recruiting.

Timeline

2 March 2025

Primary endpoint
2 November 2028

2 November 2031

Quick facts

Lead sponsor	Elsan
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	150
Start date	2 March 2025
Primary completion	2 November 2028
Estimated completion	2 November 2031
Sites	1 location across France

Drugs / interventions tested

• Ph-measurement
• Questionnaires
• gastroduodenal transit

Conditions studied

• Obesity — all drugs for Obesity →
• Hiatal Hernia — all drugs for Hiatal Hernia →

Sponsor

Elsan — full company profile →

Who can join

18 and older, any sex, with Obesity or Hiatal Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.