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

Dumping Syndrome Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891330
• Other study ID #: 2014_17
• Secondary ID: 2015-A00646-43
• Status: Completed
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: December 18, 2020

Study information

• Verified date: April 2021
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dumping Syndrome
• Syndrome

Intervention

Behavioral:
• Dietary and nutritional recommendations conducted by a nurse
Supplementary dietary and nutritional education

Locations

Country	Name	City	State
France	CH ARRAS	Arras
France	Ch Boulogne-Sur-Mer	Boulogne Sur Mer
France	Hôpital Claude Huriez, CHRU	Lille
France	Ch de Valenciennes	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of dumping syndrome	The frequency of dumping syndrome at 3 months will be compared between the two groups.	3 months
Secondary	Change in Body Mass Index		3 months
Secondary	Frequence of Adverse Events after surgery		at 1 and 3 months
Secondary	Quality of Life-Lite questionnaire	Estimation of quality of life by Impact of Weight on Quality of Life-Lite questionnaire(IWQOL-Lite)	3 months
Secondary	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