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.

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.

Study Overview

• Status: Completed
• Conditions: Dumping Syndrome
• Intervention / Treatment: Behavioral: Dietary and nutritional recommendations conducted by a nurse

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Arras, France
    • CH ARRAS
  • Boulogne Sur Mer, France, 62321
    • Ch Boulogne-Sur-Mer
  • Lille, France
    • Hôpital Claude Huriez, CHRU
  • Valenciennes, France
    • Ch de Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of dumping syndrome	The frequency of dumping syndrome at 3 months will be compared between the two groups.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index		3 months
Frequence of Adverse Events after surgery		at 1 and 3 months
Quality of Life-Lite questionnaire	Estimation of quality of life by Impact of Weight on Quality of Life-Lite questionnaire(IWQOL-Lite)	3 months
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)	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Hélène VERKINDT, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2017
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 18, 2020

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Roux-en-Y Gastric ByPass
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Stomach Diseases; Postgastrectomy Syndromes; Syndrome; Dumping Syndrome
• Other Study ID Numbers: 2014_17; 2015-A00646-43 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No