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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01980420
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
IHU Strasbourg

Tracking Information
First Submitted Date  ICMJE October 28, 2013
First Posted Date  ICMJE November 11, 2013
Last Update Posted Date September 2, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2013)
  • 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)
  • 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
  • Functional examinations [ Time Frame: 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 [ Time Frame: Intra-operatively ]
    Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure
  • Surgical video analysis [ Time Frame: within 6 months post surgery ]
    Analysis of surgery videos to detect technical "errors" explaining clinical and/or functional outcome
  • Per and post-operative complications [ Time Frame: 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 [ Time Frame: 50% excess weight loss (about 6 months post surgery) ]
  • Cost of exploratory exams [ Time Frame: Within 2 months prior to surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function
Official Title  ICMJE Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Morbid Obesity
Intervention  ICMJE Procedure: Laparoscopic sleeve gastrectomy
Conventional laparoscopic sleeve gastrectomy using EndoFLIP® probe to provide measures on the distensibility of gastro-esophageal junction (GEJ) and gastric tube.
Study Arms  ICMJE Sleeve gastrectomy
All patients will undergo sleeve gastrectomy
Intervention: Procedure: Laparoscopic sleeve gastrectomy
Publications * Quero G, Fiorillo C, Dallemagne B, Mascagni P, Curcic J, Fox M, Perretta S. The Causes of Gastroesophageal Reflux after Laparoscopic Sleeve Gastrectomy: Quantitative Assessment of the Structure and Function of the Esophagogastric Junction by Magnetic Resonance Imaging and High-Resolution Manometry. Obes Surg. 2020 Jun;30(6):2108-2117. doi: 10.1007/s11695-020-04438-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2016)
35
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2013)
30
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01980420
Other Study ID Numbers  ICMJE 13-001
2013-A00723-42 ( Other Identifier: ANSM France )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party IHU Strasbourg
Study Sponsor  ICMJE IHU Strasbourg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Silvana Perretta, Pr Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
PRS Account IHU Strasbourg
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP