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

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Laparoscopic sleeve gastrectomy

• 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

Arm && Interventions

Group	Intervention	Description
Sleeve gastrectomy	Laparoscopic sleeve gastrectomy	All patients will undergo sleeve gastrectomy

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