Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity (IRCO)
Primary Purpose
Dumping Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dietary and nutritional recommendations conducted by a nurse
Sponsored by
About this trial
This is an interventional other trial for Dumping Syndrome focused on measuring Roux-en-Y Gastric ByPass
Eligibility 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
Sites / Locations
- CH ARRAS
- Ch Boulogne-Sur-Mer
- Hôpital Claude Huriez, CHRU
- Ch de Valenciennes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dietary and nutritional recommendations
Standard of care
Arm Description
Postoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse
Postoperative standard of care
Outcomes
Primary Outcome Measures
The frequency of dumping syndrome
The frequency of dumping syndrome at 3 months will be compared between the two groups.
Secondary Outcome Measures
Change in Body Mass Index
Frequence of Adverse Events after surgery
Quality of Life-Lite questionnaire
Estimation of quality of life by Impact of Weight on Quality of Life-Lite questionnaire(IWQOL-Lite)
Personal Effectiveness Assessment questionnaire (SEPOB)
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)
Full Information
NCT ID
NCT02891330
First Posted
September 1, 2016
Last Updated
April 20, 2021
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT02891330
Brief Title
Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity
Acronym
IRCO
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
December 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dumping Syndrome
Keywords
Roux-en-Y Gastric ByPass
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary and nutritional recommendations
Arm Type
Experimental
Arm Description
Postoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Postoperative standard of care
Intervention Type
Behavioral
Intervention Name(s)
Dietary and nutritional recommendations conducted by a nurse
Intervention Description
Supplementary dietary and nutritional education
Primary Outcome Measure Information:
Title
The frequency of dumping syndrome
Description
The frequency of dumping syndrome at 3 months will be compared between the two groups.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Body Mass Index
Time Frame
3 months
Title
Frequence of Adverse Events after surgery
Time Frame
at 1 and 3 months
Title
Quality of Life-Lite questionnaire
Description
Estimation of quality of life by Impact of Weight on Quality of Life-Lite questionnaire(IWQOL-Lite)
Time Frame
3 months
Title
Personal Effectiveness Assessment questionnaire (SEPOB)
Description
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)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène VERKINDT, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH ARRAS
City
Arras
Country
France
Facility Name
Ch Boulogne-Sur-Mer
City
Boulogne Sur Mer
ZIP/Postal Code
62321
Country
France
Facility Name
Hôpital Claude Huriez, CHRU
City
Lille
Country
France
Facility Name
Ch de Valenciennes
City
Valenciennes
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity
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