Morbid Obesity
Conditions
Keywords
Sleeve gastrectomy, Oesogastric junction - GEJ, Dynamic MRI Imaging
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).
Interventions
PROCEDURELaparoscopic sleeve gastrectomy
Conventional laparoscopic sleeve gastrectomy using EndoFLIP® probe to provide measures on the distensibility of gastro-esophageal junction (GEJ) and gastric tube.
Sponsors
IHU Strasbourg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| GERD and dysphagia symptoms (GSAS questionnaire) | 50% of excess weight loss (about 6 months post surgery) | GERD (Gastroesophageal Reflux Disease) Symptom Assessment Scale |
| 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) |
| EndoFLIP® measures | Intra-operatively | Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure |
| Quality of life (GIQLI) | 50% of excess weight loss (about 6 months post surgery) | Quality of life (Gastro-Intestinal Quality of Life Index) |
| 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) |
| Cost of exploratory exams | 50% excess weight loss (about 6 months post surgery) | — |
| Surgical video analysis | within 6 months post surgery | Analysis of surgery videos to detect technical errors explaining clinical and/or functional outcome |
Countries
France
Outcome results
None listed