Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function (FFSI)
August 31, 2016 updated by: IHU Strasbourg
Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Strasbourg, France, 67000
- Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Sleeve gastrectomy
All patients will undergo sleeve gastrectomy
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Conventional laparoscopic sleeve gastrectomy using EndoFLIP® probe to provide measures on the distensibility of gastro-esophageal junction (GEJ) and gastric tube.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with postoperative GIQLI score greater than preoperative score
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
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50% excess weight loss (about 6 months post surgery)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life (GIQLI)
Time Frame: 50% of excess weight loss (about 6 months post surgery)
|
Quality of life (Gastro-Intestinal Quality of Life Index)
|
50% of excess weight loss (about 6 months post surgery)
|
|
GERD and dysphagia symptoms (GSAS questionnaire)
Time Frame: 50% of excess weight loss (about 6 months post surgery)
|
GERD (Gastroesophageal Reflux Disease) Symptom Assessment Scale
|
50% of excess weight loss (about 6 months post surgery)
|
|
Functional examinations
Time Frame: 50% of excess weight loss (about 6 months post surgery)
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Include:
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50% of excess weight loss (about 6 months post surgery)
|
|
EndoFLIP® measures
Time Frame: Intra-operatively
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Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure
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Intra-operatively
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Surgical video analysis
Time Frame: within 6 months post surgery
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Analysis of surgery videos to detect technical "errors" explaining clinical and/or functional outcome
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within 6 months post surgery
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Per and post-operative complications
Time Frame: within 6 months post surgery
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Complications occuring during surgery and within 6 months of surgery (reach of 50% of excess weight loss)
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within 6 months post surgery
|
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Cost of exploratory exams
Time Frame: 50% excess weight loss (about 6 months post surgery)
|
50% excess weight loss (about 6 months post surgery)
|
|
|
Cost of exploratory exams
Time Frame: Within 2 months prior to surgery
|
Within 2 months prior to surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Silvana Perretta, Pr, Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
October 28, 2013
First Submitted That Met QC Criteria
November 4, 2013
First Posted (Estimate)
November 11, 2013
Study Record Updates
Last Update Posted (Estimate)
September 2, 2016
Last Update Submitted That Met QC Criteria
August 31, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-001
- 2013-A00723-42 (Other Identifier: ANSM France)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.