This study aims to describe the long-term results of a randomized trial comparing LAGB and VBG with regard to clinical results and quality of life.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. medication
2. postoperative complications
3. re-operations
4. comorbidity
5. symptoms and complaints
6. dietary habits
7. blood pressure measurement
Laboratory measurements:
1. hemoglobin, urea, creatinin, ASAT, ALAT
2. albumin, total protein
3. cholesterol, triglycerides, HDL, LDL
4. iron, zinc, vitamin B1, B6, B12, folic acid
Qaulity of life:
1. Nottingham Health Profile I (NHP-I)
2. Nottingham Health Profile II (NHP-II)
3. Visual Analog Scale (VAS)
3. Sickness Impact Profile (SIP)
Secondary outcome
none
Background summary
The long-term results of the laparoscopic adjustable gastric banding (LAGB) are
not well known. The value of this technique has been studied in randomized
trials in comparison with the vertical banded gastroplasty (VBG). However, only
short-term results are described and it is well known that in this patient
group complications can arise after many years. Moreover, in the literature it
appears that afer VBG the weight loss is quick but tens to seize after 2 years
while after LAGB the weight loss is slowly but more durable.
The positive results after bariatric surgery on the quality of life is well
described in literature. However, this has never been done in a prospective and
randomized manner.
Study objective
This study aims to describe the long-term results of a randomized trial
comparing LAGB and VBG with regard to clinical results and quality of life.
Study design
All 100 patients of the first study (number 98-112.3) will be asked to visit
the outpatient department once. Quality of life questionnaires will be send to
the patients beforehand so they can bring these outfilled. During the visit
questions will be asked about clinical results, complications and
re-operations. Blood pressure will be measured and 10 ml of blood will be drawn
with venapunction.
Intervention
none
Study burden and risks
Outpatient department visit of 20 minutes, outfilling of questionnaires (45
minutes) and drawing of 10 ml blood by venapunction.
P.Debyelaan 25
6202 AZ Maastricht
Nederland
P.Debyelaan 25
6202 AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
patients with morbid obesity included in study 98-112.3
Exclusion criteria
none
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15921.068.07 |