Dumping SyndromeIRCONCT02891330
Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity
A study testing Dietary and nutritional recommendations conducted by a nurse in people with Dumping Syndrome, run by University Hospital, Lille at 4 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dumping Syndrome
- What is being tested?
- Dietary and nutritional recommendations conducted by a nurse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 4 sitesFrance
- Study dates
- 2 Mar 2017to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to Roux-en-Y Gastric ByPass
- Refusal to sign the consent form
- Patient not affiliated to a social security system
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH ARRAS
Arras
Ch Boulogne-Sur-Mer
Boulogne-sur-Mer, 62321
Hôpital Claude Huriez, CHRU
Lille
Ch de Valenciennes
Valenciennes
About this study
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.
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.
Read the 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
- Being tested
- Dietary and nutritional recommendations conducted by a nurse
- Keywords
- Roux-en-Y Gastric ByPass
- Medical subject headings
- Dumping Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and nutritional recommendations conducted by a nurseBehavioural
Supplementary dietary and nutritional education
| Study group | Role | What they receive |
|---|---|---|
| Dietary and nutritional recommendations | Experimental | Postoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse Receives: Behavioral: Dietary and nutritional recommendations conducted by a nurse |
| Standard of care | No intervention | Postoperative standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of dumping syndrome
The frequency of dumping syndrome at 3 months will be compared between the two groups.
Measured: 3 months
Secondary outcomes (4)
Change in Body Mass Index
Measured: 3 months
Frequence of Adverse Events after surgery
Measured: 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)
Measured: 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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start2 Mar 2017
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dumping SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène VERKINDT, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891330
- Sponsor's protocol ID
- 2014_17
- Other IDs
- 2015-A00646-43
- Acronym
- IRCO
- Status last verified
- Apr 2021
- First submitted
- 1 Sep 2016
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02891330
- Acronym / sponsor ID
- IRCO / 2014_17
- Conditions
- Dumping Syndrome
- Keywords
- Roux-en-Y Gastric ByPass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary and nutritional recommendations | Experimental | Behavioral: Dietary and nutritional recommendations conducted by a nursePostoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse |
| Standard of care | No intervention | –Postoperative standard of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Contraindication to Roux-en-Y Gastric ByPass
- Refusal to sign the consent form
- Patient not affiliated to a social security system
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary and nutritional recommendations conducted by a nurseSupplementary dietary and nutritional education | Behavioural | Dietary and nutritional recommendations |
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.
4 secondary outcomes
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
Personal Effectiveness Assessment questionnaire (SEPOB)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Dumping Syndrome
Active, not recruiting
Feasibility Study of Middle Segmental Gastrectomy (MSG) for Gastric Cancer.
Gastric Cancer, Gastric Adenocarcinoma
RecruitingObservational study
Dumping Syndrome After Esophagectomy
Esophagectomy, Dumping Syndrome
Recruiting
Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
Dumping Syndrome, Post-bariatric Hypoglycemia
Recruiting
Dumping Syndrome and Esophageal Atresia
Oesophageal Atresia, Dumping Syndrome
Active, not recruiting
Comparing Dumping Symptoms and Quality of Life 6 Months After Sleeve Gastrectomy With or Without Transit Bipartition in Adults With Obesity
Obesity, Morbid Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène VERKINDT, MD principal investigator
University Hospital, Lille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary and nutritional recommendations conducted by a nurse in people with Dumping Syndrome, run by University Hospital, Lille at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of dumping syndrome (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.