Objective: The primary objective is to evaluate if %EWL after LSG as bariatric therapy is equal or, within an acceptable margin, inferior to LRYGB. Secondary objectives are to evaluate QOL, cure /improvement of obesity related co-morbidity (i.e. DM-…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The primary and-point is %EWL at 5-years
follow-up period.
Secondary outcome
Secondary end-points are health related QOL, morbidity/mortality, readmission,
reoperations, re-do surgery.
Background summary
Rationale: Morbid obesity has become one of the most frequent chronic disorders
in Western countries, affecting 1.5-2% of the Dutch population. Currently, as
the laparoscopic banding procedure is declining in popularity due to its poor
percentage Extra Weight Loss (%EWL) results and its high rate of late serious
complications, the Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) seems to be
one of the best options as a treatment for morbid obesity. However, the higher
risk of dumping syndrome makes it a potentially less attractive option due to
its negative effects on the quality of life. Laparoscopic Sleeve Gastrectomy
(LSG) is a new promising bariatric procedure which has the theoretical
advantages of keeping the gastrointestinal tract intact, making it possible to
perform endoscopic therapy (gastroscopy, ERCP) after LSG. Because there is no
bypass of the jejunum there is theoretically a smaller chance of vitamin
deficits and a better QOL. LSG is further an easier and faster procedure. Short
term prospective small patient-studies show equal %EWL of both techniques,
however long-term results on %EWL of the LSG are not available. The aim of the
research proposal, a randomised long-term (5-year FU) comparing LSG with LRYGB,
is to clarify this question and analyse the impact on quality-of-life (QOL) of
these patient-groups. As certain subgroups (type 2 Diabetes Mellitus (DM-2);
BMI >50; sweet eaters; Gastro Esophagal Reflux Disease (GERD)) can have
different outcomes compared to those who do not belong to such subgroups, this
study explictly takes subgroup analysis into account.
Study objective
Objective:
The primary objective is to evaluate if %EWL after LSG as bariatric therapy is
equal or, within an acceptable margin, inferior to LRYGB.
Secondary objectives are to evaluate QOL, cure /improvement of obesity related
co-morbidity (i.e. DM-2, hypertension, hypercholesterolemia, Obstructive Sleep
Apnoea Syndrome (OSAS), GERD, weight induced joint pain), complications,
readmission rate, re-operation rate, revisive surgery (Re-do) rate, return to
work rate. Furthermore, this study evaluates if combining the bariatric
procedure with a cholecystectomy in morbidly obese patients with gallbladder
stones is to be advocated. Moreover, technical aspects of the LSG and the LRYGB
like OR time, blood loss, technical complications and difficulties will be
evaluated.
Study design
Study design: A randomized, open label, multicenter non-inferiority trial
comparing bariatric treatment of morbid obesity by either LSG or LRYGB.
Intervention
Intervention: LSG
Control: LRYGB
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Both treatments in this study are performed on
regular basis as a stand-alone therapy for morbid obesity in the Netherlands
and abroad, with rising rates of LSG and LRYGB. The place of the LSG as a
stand-alone therapy is unknown as long-term results are currently lacking.
However, short term results are promising and two short term prospective
randomized small-size patient-studies show equal results in terms of %EWL
(17,18). The only difference compared to standard LRYGB treatment is that
patients have to fill out three QOL-questionnaires on admission and after
3,6,12, 24, 36, 48, 60 months and have to undergo an additional gallbladder
ultrasound investigation prior to surgery. The additional burden for study
participants is considered to be minimal.
Kleiweg 500
3045 PM
NL
Kleiweg 500
3045 PM
NL
Listed location countries
Age
Inclusion criteria
• Age 18-60 years
• BMI> 40, or > 35 kg/m2 with pronounced co-morbidity, for more than 3 years
• Conservative therapy - preferably under the guidance of a physician or self help group - has failed or showed only transient results
• Psychological screening excluding psychiatric and psychological disorders
• Written informed consent and willing to enter the follow up program after surgery.
Exclusion criteria
Prior bariatric surgery
• Prior major abdominal surgery (like colonic resection, septic abdomen, aorta surgery, which might jeopardise the technical feasibility of LSG or LRYGB)
• BMI > 60 kg/m2
• ASA (American Society for Anesthesiologists) classification >= IV
• Pregnant women
• Endocrine causes, alcohol or drug abuse
• Severe concomitant disease (carcinomas, neurodegenerative disorders or other disorders presently representing being considered exclusion criteria for bariatric surgery )
• The inability of reading/understanding and filling out questionnaires
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 | NL37501.101.11 |
| OMON | NL-OMON25900 |