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OpenTrials
Completed

NCT Number: NCT02891330

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH ARRAS, Arras, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary and nutritional recommendations conducted by a nurse

Behavioral

Supplementary dietary and nutritional education

Primary outcomes

  1. The frequency of dumping syndrome

    Time frame: 3 months

    The frequency of dumping syndrome at 3 months will be compared between the two groups.

Secondary outcomes

  1. Change in Body Mass Index

    Time frame: 3 months

  2. Frequence of Adverse Events after surgery

    Time frame: at 1 and 3 months

  3. Quality of Life-Lite questionnaire

    Time frame: 3 months

    Estimation of quality of life by Impact of Weight on Quality of Life-Lite questionnaire(IWQOL-Lite)

  4. Personal Effectiveness Assessment questionnaire (SEPOB)

    Time frame: 3 months

    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)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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.

Acronym: IRCO

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 7, 2016
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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