Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Strasbourg, 67000, France
NCT Number: NCT01980420
Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Strasbourg, 67000, France
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion criteria:
Conventional laparoscopic sleeve gastrectomy using EndoFLIP® probe to provide measures on the distensibility of gastro-esophageal junction (GEJ) and gastric tube.
Time frame: 50% excess weight loss (about 6 months post surgery)
Patients with postoperative GIQLI (Gastro-Intestinal Quality of Life Index) score greater than preoperative score
Time frame: 50% of excess weight loss (about 6 months post surgery)
Quality of life (Gastro-Intestinal Quality of Life Index)
Time frame: 50% of excess weight loss (about 6 months post surgery)
GERD (Gastroesophageal Reflux Disease) Symptom Assessment Scale
Time frame: 50% of excess weight loss (about 6 months post surgery)
Include:
Time frame: Intra-operatively
Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure
Time frame: within 6 months post surgery
Analysis of surgery videos to detect technical "errors" explaining clinical and/or functional outcome
Time frame: within 6 months post surgery
Complications occuring during surgery and within 6 months of surgery (reach of 50% of excess weight loss)
Time frame: 50% excess weight loss (about 6 months post surgery)
Time frame: Within 2 months prior to surgery
IHU Strasbourg
Other
Acronym: FFSI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07639502
Body Weight, Morbid Obesity
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06199635
Body Weight, Morbid Obesity
Santiago, Huechuraba, Región Metropolitana, Chile
View Trial DetailsNCT06268990
Body Weight, Diabetes
Graz, Austria
View Trial DetailsNCT07662538
Body Weight, Digestive System Diseases
Istanbul, Turkey (Türkiye)
View Trial Details