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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
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dumping Syndrome focused on measuring Roux-en-Y Gastric ByPass

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 1, 2016
Last Updated
April 20, 2021
Sponsor
University Hospital, Lille
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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

Learn more about this trial

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

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