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Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity (IRCO)

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ClinicalTrials.gov Identifier: NCT02891330
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
The postprandial dumping syndrome is a frequent consequence of Roux-en-Y Gastric ByPass due to the rapid emptying of the stomach remnant in to the intestinal lumen. Dumping-related symptoms occur very early after eating (within 30 minutes), are not associated with concurrent hypoglycemia, and are most prominent in the early postoperative period. This syndrome very debilitating for the patient can be improved by dietary and nutritional recommendations. We hypothesize that a personalized approach based on dietary and nutritional recommendations conducted by a nurse would likely to decrease the frequency of dumping syndrome and improve the postoperative quality of life of patients in the early postoperative period.

Condition or disease Intervention/treatment Phase
Dumping Syndrome Behavioral: Dietary and nutritional recommendations conducted by a nurse Not Applicable

Detailed Description:
The Roux-en-Y Gastric ByPass is considered the gold standard of weight loss surgery and is the most commonly performed bariatric procedure worldwide.The postprandial dumping syndrome is a frequent consequence of gastrojejunal anastomosis due to the rapid emptying of the stomach remnant in to the intestinal lumen. Dumping-related symptoms occur very early after eating (within 30 minutes), are not associated with concurrent hypoglycemia, and are most prominent in the early postoperative period. The symptoms of dumping syndrome include nausea, abdominal cramps, diarrhea, dizzy spells, weakness and cold sweats either with or after eating.This syndrome very debilitating for the patient can be improved by dietary and nutritional recommendations. We hypothesize that an individualized approach based on dietary and nutritional recommendations and monitoring of patients conducted by a nurse in the first three months after surgery would likely to decrease these problems and improve the postoperative quality of life of patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessing the Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity With the Risk of Occurrence of Dumping Syndrome After Gastric Bypass.
Actual Study Start Date : March 2, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Dietary and nutritional recommendations
Postoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse
Behavioral: Dietary and nutritional recommendations conducted by a nurse
Supplementary dietary and nutritional education

No Intervention: Standard of care
Postoperative standard of care



Primary Outcome Measures :
  1. The frequency of dumping syndrome [ Time Frame: 3 months ]
    The frequency of dumping syndrome at 3 months will be compared between the two groups.


Secondary Outcome Measures :
  1. Change in Body Mass Index [ Time Frame: 3 months ]
  2. Frequence of Adverse Events after surgery [ Time Frame: at 1 and 3 months ]
  3. Quality of Life-Lite questionnaire [ Time Frame: 3 months ]
    Estimation of quality of life by Impact of Weight on Quality of Life-Lite questionnaire(IWQOL-Lite)

  4. Personal Effectiveness Assessment questionnaire (SEPOB) [ Time Frame: 3 months ]
    Measure the efficacy of therapeutic education by personal estimation of the level of skill using a specific obesity assessment questionnaire (SEPOB questionnaire or survey emotional, cognitive and behavioral sense of personal efficacy)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index ≥40 kg / m2 or ≥35 kg / m2 in the presence of comorbidities related to obesity
  • Indication to Roux-en-Y Gastric ByPass

Exclusion Criteria:

  • Contraindication to Roux-en-Y Gastric ByPass
  • Refusal to sign the consent form
  • Patient not affiliated to a social security system
  • Pregnancy

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): NCT02891330


Contacts
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Contact: Hélène VERKINDT, MD +33 3 20 44 45 51 ext +33 helene.verkindt@chru-lille.fr
Contact: Christine VERHELST christine.verhelst@chru-lille.fr

Locations
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France
Hôpital Claude Huriez, CHRU Recruiting
Lille, France
Principal Investigator: Hélène Verkindt, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Hélène VERKINDT, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02891330    
Other Study ID Numbers: 2014_17
2015-A00646-43 ( Other Identifier: ID-RCB number, ANSM )
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Roux-en-Y Gastric ByPass
Additional relevant MeSH terms:
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Dumping Syndrome
Syndrome
Disease
Pathologic Processes
Postgastrectomy Syndromes
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications