Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function

Not Applicable

Completed

• Conditions: Morbid Obesity

• Registration Number: NCT01980420
• Lead Sponsor: IHU Strasbourg

Brief Summary

Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.

Detailed Description

Effectiveness of sleeve gastrectomy is between gastric banding and gastric bypass. However, a proportion of patients that undergo surgery, report troublesome and persistent dysphagia, pain, new onset or worsening of gastro-esophageal reflux (GER) requiring treatment. Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome. Current investigations based on traditional intra-luminal imaging (endoscopy) and radiology (UGI series) may not provide adequate preoperative assessment of esophago-gastric dynamics. Current practice in the creation of a sleeve gastrectomy involves the use of a bougie or endoscope around which the sleeve is stapled. There is no consensus on the diameter of this bougie and this intraoperative calibration may alter the gastro-esophageal junction (GEJ) anatomy, does not provide real time physiology feedback, and allows only for a rough approximation of the size of the sleeve providing no information about the distensibility and pressure gradient of the newly created gastric tube as it is filled. A more distensible sleeve will have lower intra-gastric pressure, and thus will theoretically be expected to reduce the incidence of side effects. As laparoscopic sleeve gastrectomy is performed with increasing frequency, there is a need for development of tools to assist the surgeon in modeling properly and standardize the gastroplasty. This study will be based on a strict assessment of the anatomical and functional characteristics of the "ideal "gastric sleeve, using existing imaging modalities (endoscopy - CT scan- MRI - HRM).

Study Timeline

• Study First Submitted: 2013-10-28
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patient, male or female over 18 years old
• Patient scheduled to undergo a sleeve gastrectomy for obesity
• Patient with surgical indication validated by the obesity multidisciplinary meeting (RCP)
• Patient able to understand the study and to provide written informed consent
• Patient registered with the French social security regime

Non-inclusion criteria:

• Patient unable to give written informed consent
• Patient presenting contra-indication to the conduct of an MRI (claustrophobia, implantable medical devices)
• Patient presenting risks of allergic reaction to MRI contrast agents (gadolinium)
• Patient presenting, in the investigator's judgment, a condition or disease preventing their participation to study procedures
• Patient pregnant or breast-feeding
• Patient within exclusion period from other clinical trial
• Patient having forfeited their freedom of an administrative or legal obligation
• Patient being under guardianship

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with postoperative GIQLI score greater than preoperative score	50% excess weight loss (about 6 months post surgery)	Patients with postoperative GIQLI (Gastro-Intestinal Quality of Life Index) score greater than preoperative score

Secondary Outcome Measures

Name	Time	Method
Quality of life (GIQLI)	50% of excess weight loss (about 6 months post surgery)	Quality of life (Gastro-Intestinal Quality of Life Index)
Functional examinations	50% of excess weight loss (about 6 months post surgery)	Include: * Dynamic MRI; * High resolution manometry; * pH impedance; * upper gastro-intestinal study (UGI)
Cost of exploratory exams	Within 2 months prior to surgery
GERD and dysphagia symptoms (GSAS questionnaire)	50% of excess weight loss (about 6 months post surgery)	GERD (Gastroesophageal Reflux Disease) Symptom Assessment Scale
EndoFLIP® measures	Intra-operatively	Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure
Per and post-operative complications	within 6 months post surgery	Complications occuring during surgery and within 6 months of surgery (reach of 50% of excess weight loss)
Surgical video analysis	within 6 months post surgery	Analysis of surgery videos to detect technical "errors" explaining clinical and/or functional outcome

Trial Locations

Locations (1)

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France