NCT06835790

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Elsan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obesity
• Hiatal Hernia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-03-02
• Primary completion: 2028-11-02
• Completion: 2031-11-02
• First posted: 2025-02-19
• Last updated: 2025-02-19

Locations

1 site across 1 country: France