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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: The Roux-en-Y Gastric ByPass is considered the gold standard of weight loss surgery and is the most commonly performed bariatric procedure worlwide.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.
Sponsor: University Hospital, Lille

Current Primary Outcome: The frequency of dumping syndrome [ Time Frame: 3 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Body Mass Index [ Time Frame: 3 months ]
  • Frequence of Adverse Events after surgery [ Time Frame: at 1 and 3 months ]
  • 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)
  • 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)


Original Secondary Outcome:

  • Body Mass Index [ Time Frame: 3 months ]
    Body Mass Index
  • Frequence of Adverse Events after surgery [ Time Frame: at 1 and 3 months ]
  • 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)
  • 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)


Information By: University Hospital, Lille

Dates:
Date Received: September 1, 2016
Date Started: March 2, 2017
Date Completion: December 2018
Last Updated: May 18, 2017
Last Verified: May 2017