The aim of this study is to investigate the effect of two distalisation techniques of a gastric bypass in revisional surgery with standardised limb lengths in total weight loss (TWL) and the need for treatment for protein calorie malnutrition (PCM…
ID
Source
Brief title
Condition
- Other condition
- Malabsorption conditions
- Gastrointestinal therapeutic procedures
Synonym
Health condition
Obesitas, bariatrische chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
%total weight loss 1 year after treatment and need for treatment of protein
calory malnutrition.
Secondary outcome
weight loss, co-morbidity remission, protein calory malnutrition grading
(debilitating defecation patterns, temporary total parenteral nutrition
treatment, revision, mortality), morbidity, nutritional deficiencies, quality
of life and patient satisfaction.
Background summary
Up to 35% of morbidly obese patients undergoing Roux-en-Y gastric bypass (RYGB)
fail to lose sufficient weight or regain excessive weight after initial weight
loss. Currently, there is no standardized approach to revisional surgery after
failed RYGB. Distalisation of the RYGB limbs (DGB), with shortening of the
common channel and extending either the alimentary limb (AL) or biliopancreatic
limb (BPL), can be performed as revisional surgery to induce additional weight
loss. To date, there is no general consensus as to optimal surgical technique
or limb lengths to be used in distalisation of RYGB in both literature as well
as clinical practice.
Study objective
The aim of this study is to investigate the effect of two distalisation
techniques of a gastric bypass in revisional surgery with standardised limb
lengths in total weight loss (TWL) and the need for treatment for protein
calorie malnutrition (PCM). In this randomised controlled trial DGB with
lengthening of the BPL (DGB type I) will be compared to DGB with extended AL
(DGB type II) in order to conclude which surgical technique is the optimal
therapeutic strategy as revision surgery following Roux-en-Y gastric bypass.
Study design
Randomised controlled trial.
Intervention
A total of 150 participants will be randomised over two treatment groups: group
A will undergo DGB type I and group B will undergo DGB type II.
Study burden and risks
Participants will undergo either DGB type I or DGB type II. The treatment and
pre- and postoperative care will not differ from the regular DGB revisional
treatment for failed RYGB. Therefore, there are no additional risks associated
to this treatment.
Additionally, participants will be asked to fill out written questionnaires
regarding defecation patterns and QoL preoperatively as well as 3, 12 and 36
months after treatment.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
• Age 18-65 years;
• BMI >=40 kg/m2 or BMI >=35 kg/m2 with obesity related comorbidity;
• Weight regain or insufficient weight loss (EWL<50% or TWL<20%) following RYGB;
• Multidisciplinary team screening at one of the bariatric centres;
• Informed consent and willing to enter the follow-up program.
Exclusion criteria
• Failed Roux-en-Y gastric bypass due to anatomic, surgical reasons (gastric
pouch dilatation >50 mL, gastro-gastric fistula, gastro-jejunostomy);
• Distalisation of RYGB is technical infeasible (judgment by surgeon);
• Inflammatory bowel disease, celiac disease, irritable bowel syndrome and
other causes of chronic diarrhea;
• Severe concomitant disease (such as carcinomas and neurodegenerative
disorders);
• Pregnant women;
• Noncompliance in follow-up or unwilling to undergo surgery;
• Inability of reading/understanding and filling out questionnaires.
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 | NL75322.100.20 |