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

NCT ID: NCT02891330

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-02
• Study Completion Date: 2020-12-18

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.

Conditions

Dumping Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dietary and nutritional recommendations

Postoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse

Group Type: EXPERIMENTAL

Dietary and nutritional recommendations conducted by a nurse

Intervention Type: BEHAVIORAL

Supplementary dietary and nutritional education

Standard of care

Postoperative standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary and nutritional recommendations conducted by a nurse

Supplementary dietary and nutritional education

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hélène VERKINDT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

CH ARRAS

Arras, , France

Ch Boulogne-Sur-Mer

Boulogne-sur-Mer, , France

Hôpital Claude Huriez, CHRU

Lille, , France

Ch de Valenciennes

Valenciennes, , France

Countries

France

Other Identifiers

2015-A00646-43

Identifier Type: OTHER

Identifier Source: secondary_id

2014_17

Identifier Type: -

Identifier Source: org_study_id