Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Brief Summary:
Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Laparoscopic sleeve gastrectomy Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function
Study Start Date : November 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Sleeve gastrectomy
All patients will undergo sleeve gastrectomy
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. EndoFLIP® measures [ Time Frame: Intra-operatively ]
    Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure

  5. Surgical video analysis [ Time Frame: within 6 months post surgery ]
    Analysis of surgery videos to detect technical "errors" explaining clinical and/or functional outcome

  6. 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)

  7. Cost of exploratory exams [ Time Frame: 50% excess weight loss (about 6 months post surgery) ]
  8. Cost of exploratory exams [ Time Frame: Within 2 months prior to surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980420


Locations
Layout table for location information
France
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Strasbourg, France, 67000
Sponsors and Collaborators
IHU Strasbourg
Investigators
Layout table for investigator information
Principal Investigator: Silvana Perretta, Pr Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT01980420    
Other Study ID Numbers: 13-001
2013-A00723-42 ( Other Identifier: ANSM France )
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Keywords provided by IHU Strasbourg:
Sleeve gastrectomy
Oesogastric junction - GEJ
Dynamic MRI Imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight