Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Conventional laparoscopic sleeve gastrectomy using EndoFLIP® probe to provide measures on the distensibility of gastro-esophageal junction (GEJ) and gastric tube.
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Strasbourg, France
Number of patients with postoperative GIQLI score greater than preoperative score
Patients with postoperative GIQLI (Gastro-Intestinal Quality of Life Index) score greater than preoperative score
Time frame: 50% excess weight loss (about 6 months post surgery)
Quality of life (GIQLI)
Quality of life (Gastro-Intestinal Quality of Life Index)
Time frame: 50% of excess weight loss (about 6 months post surgery)
GERD and dysphagia symptoms (GSAS questionnaire)
GERD (Gastroesophageal Reflux Disease) Symptom Assessment Scale
Time frame: 50% of excess weight loss (about 6 months post surgery)
Functional examinations
Include: * Dynamic MRI * High resolution manometry * pH impedance * upper gastro-intestinal study (UGI)
Time frame: 50% of excess weight loss (about 6 months post surgery)
EndoFLIP® measures
Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure
Time frame: Intra-operatively
Surgical video analysis
Analysis of surgery videos to detect technical "errors" explaining clinical and/or functional outcome
Time frame: within 6 months post surgery
Per and post-operative complications
Complications occuring during surgery and within 6 months of surgery (reach of 50% of excess weight loss)
Time frame: within 6 months post surgery
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Cost of exploratory exams
Time frame: 50% excess weight loss (about 6 months post surgery)
Cost of exploratory exams
Time frame: Within 2 months prior to surgery