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

Launched by ELSAN · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical approaches for treating obesity in patients who also have a hiatal hernia, which is a condition where part of the stomach pushes through the diaphragm. The two methods being compared are the Nissen-sleeve procedure and the traditional sleeve gastrectomy combined with cruroplasty (a repair of the hiatal hernia). The main goal is to see which option leads to fewer problems with gastroesophageal reflux disease (GERD), a common issue where stomach acid flows back into the esophagus, over a period of three years.

To participate in this study, candidates must be adults with severe obesity (a body mass index greater than 35) and a hiatal hernia that is 4 cm or smaller. They should not have poorly controlled diabetes or any major issues with their esophagus. Participants can expect to undergo surgery and be followed for three years to monitor for any worsening of GERD symptoms. This study is important because it aims to find the best surgical approach for obese patients with hiatal hernias, which could help improve their long-term health and quality of life.

Gender

ALL

Eligibility criteria

• 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.