An interventional study of Ph-measurement and Questionnaires in Obesity and Hiatal Hernia, sponsored by Elsan. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Elsan · Not applicable, Interventional, and Other
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 150 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Elsan is the lead sponsor of 68 studies on the registry; 35 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Ph-measurement · Other: Questionnaires · Diagnostic Test: gastroduodenal transit
Diagnostic Test: Ph-measurement · Other: Questionnaires · Diagnostic Test: gastroduodenal transit
Ph measurement before and after the surgery
GERD-HRQL Reflux symptom index scale before and after surgery
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).
Appearance of GERD 3 years after surgery.
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).
Time frame: 3 years
Worsening of GERD 3 years after surgery.
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.
Time frame: 3 years
Start is estimated for Mar 2025; primary completion for Nov 2028, 44 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 44 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
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This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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