To implement and assess the feasibility, efficacy and safety of bariatric surgery in adolescents with severe obesity together with a multidisciplinary care pathway around the procedure.
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Health condition
Obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is a composite outcome:
- Proportion of adolescents presented to the national board achieving 20% total
weight loss (%TWL) 1 year after surgery;
- Incidence of adverse health events and additional surgical intervention
during 5 years follow-up.
Secondary outcome
The secondary outcomes are:
(i) Number of appointments per discipline and follow-up attendance during 5
years follow-up;
(ii) Patient satisfaction at 1, 3 and 5 years after surgery and satisfaction of
the multidisciplinary team members after 1, 3 and 5 years from start of the
study;
(iii) Perceived organization of care by the multidisciplinary team members
after 1, 3 and 5 years from start of the study.
(iv) Change in body weight, change in body mass index (BMI), %TWL and change in
BMI standard deviation score during 5 years follow-up;
(v) Prevalence and remission of obesity-related comorbidities during 5 years
follow-up;
(vi) Prevalence of cardio metabolic health parameters during 5 years follow-up;
(vii) Bone health measures and incidence of bone fractures during 5 years
follow-up;
(viii) Quality of life, psychosocial health measures, and educational
attainment at 1, 3 and 5 years after surgery;
(ix) Body composition at 2 and 5 years after surgery.
The secondary endpoints iv, v, vi and viii stated above will be used for this
historical cohort as well.
Background summary
Bariatric surgery is currently the most effective treatment for severe obesity
in adults. Recent data also supports the use of bariatric surgery in selected
adolescents suffering from severe obesity who don*t show successful weight
reduction and remission of comorbidities in the multimodal lifestyle
intervention programs. SG and the RYGB have both shown successful weight loss
and reduction of obesity related comorbidities in adolescents thus far. In the
Netherlands bariatric surgery in adolescents is only allowed in the context of
scientific research. Therefore, we propose a prospective cohort study of
adolescents with severe obesity undergoing SG or RYGB in combination with a
multidisciplinary lifestyle intervention, in order to implement this treatment
modality in the Netherlands.
Additionaly, this prospective cohort will be compared with a historical cohort
of patients who only received a lifestyle intervention.
Study objective
To implement and assess the feasibility, efficacy and safety of bariatric
surgery in adolescents with severe obesity together with a multidisciplinary
care pathway around the procedure.
Study design
A multicenter prospective cohort study with a sample size of 150 participants.
This prospective cohort will be compared with a historical cohort of
adolescents who participated in a lifestyle intervention program (COACH -
MUMC+).
Intervention
The adolescents will either receive RYGB or SG, based on the preference of the
adolescent and the surgeon. Both procedures will be combined with a lifestyle
intervention program. The adolescents with pre-existing reflux complaints or a
diaphragmatic hernia will receive a RYGB.
Study burden and risks
All patients are at risk for the complications associated with a surgery in
general, for the complication specific associated with the bariatric procedures
(including anastomotic leak, internal herniation, gall stone formation, gastric
ulcer, reflux, transient loss of hair, deficiencies of several vitamins and
minerals, dyspepsia, dumping syndrome and food intolerance).
Regarding the burden; the participants need to attend the same follow-up visits
as adults after bariatric surgery, according to the standard care for adults,
combined with the usual care in the lifestyle intervention programs. The same
applies for the blood sampling and the ultrasound of the liver. Patients who
are included in this study will be asked to fill out multiple questionnaires.
The time estimated to fill out these questionnaires is in total 80 minutes.
Furthermore, the patients will receive a DEXA scan 3 times during the study.
Besides this, a bariatric intervention requires life changing life style
adjustments, especially in the way of eating.
The benefits of participating in this study include that untreatable patients
receive a bariatric intervention as being an evidence based successful
treatment to lose weight and experience remission of comorbidities.
Furthermore, other positive effects may occur, such as improvement of quality
of life and the mprovement of school performances, as reported in previous
studies.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
(i) Completed a minimum of twelve months in formal lifestyle intervention
and/or pharmacotherapy weight loss program;
(ii) Age 13-17 with Tanner stage >= IV;
(iii) Severe obesity meeting IFSO criteria for bariatric surgery, BMI >=40 kg/m2
with minor comorbidities or BMI >=35 kg/m2 with at least one major comorbidity,
corrected for age and sex according to the IOTF criteria;
(iv) Consensus in the multidisciplinary child obesity team, during the
multidisciplinary meeting, on a strongly motivated participation of the
participant during the lifestyle intervention program so far and in the future
(after the bariatric surgery); the participant must have been fully committed
to be successful in this program and is expected to continue with this effort
after bariatric surgery;
(v) Consensus in the multidisciplinary child obesity team on the diagnosis of
non-responding to multidisciplinary lifestyle interventions for now and the
near future.
Exclusion criteria
- Unable to consent as appropriate;
- Illiteracy (disability to read and understand questionnaires);
- Secondary obesity, obesity caused by a medical condition;
- Known syndrome (e.g. Prader-Willi syndrome);
- Skeletal immaturity (Tanner stage <=III) - pre-menarche - bone age < 15 years
in boys;
- Ongoing addiction (alcohol, drugs, medication);
- Previous bariatric, gastro-esophageal reflux or gastric surgery;
- Uncontrolled Psychiatric disorders;
- IBD;
- Non-support / consent of both parents / caretakers for children aged 13-15
years.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63184.015.17 |
| Other | NTR: NTR7191 |
| OMON | NL-OMON20900 |