Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity
IRCO
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.
2 other identifiers
interventional
135
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 7, 2016
CompletedStudy Start
First participant enrolled
March 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2020
CompletedApril 21, 2021
April 1, 2021
3.8 years
September 1, 2016
April 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The frequency of dumping syndrome
The frequency of dumping syndrome at 3 months will be compared between the two groups.
3 months
Secondary Outcomes (4)
Change in Body Mass Index
3 months
Frequence of Adverse Events after surgery
at 1 and 3 months
Quality of Life-Lite questionnaire
3 months
Personal Effectiveness Assessment questionnaire (SEPOB)
3 months
Study Arms (2)
Dietary and nutritional recommendations
EXPERIMENTALPostoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse
Standard of care
NO INTERVENTIONPostoperative standard of care
Interventions
Supplementary dietary and nutritional education
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindication to Roux-en-Y Gastric ByPass
- Refusal to sign the consent form
- Patient not affiliated to a social security system
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CH ARRAS
Arras, France
Ch Boulogne-Sur-Mer
Boulogne-sur-Mer, 62321, France
Hôpital Claude Huriez, CHRU
Lille, France
Ch de Valenciennes
Valenciennes, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hélène VERKINDT, MD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2016
First Posted
September 7, 2016
Study Start
March 2, 2017
Primary Completion
December 18, 2020
Study Completion
December 18, 2020
Last Updated
April 21, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share