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

IHU Strasbourg

Status

Completed

Conditions

Morbid Obesity

Treatments

Procedure: Laparoscopic sleeve gastrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01980420

2013-A00723-42 (Other Identifier)

13-001

Details and patient eligibility

About

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

Full 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).

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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