The objective of this study is to find out whether a 150cm BPL-length OAGB is just as good in treating morbidly obese adults when compared to a 150cm BPL-length RYGB with a 75cm Roux-limb in terms of percentage excess BMI loss and nutritional…
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Gastrointestinal therapeutic procedures
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
% excess BMI loss at 2 years
Secondary outcome
% Excess BMI loss at 5 years
Operation time (measured in minutes, from incision until closure),
Diabetes remission (measured in HbA1c%, fasting plasma glucose and the need for
anti-diabetic medication will be recorded)
Hypertension remission (need for anti-hypertensive medication will be
recorded),
Post-operative complications (<30 days) based on the Comprehensive Complication
Index (CCI, Clavien-Dindo grade III-V complications),
Late complications (>30 days; e.g. bowel obstruction, internal herniation or
revision surgery),
Dyslipidaemia control (measured by LDL and total cholesterol and the need for
lipid-lowering medication will be recorded),
Diarrhea (measured using the Bristol Stool Chart, in combination with the stool
frequency),
Malnutrition (measured by serum albumin),
Mineral and vitamin deficiencies (measured by serum calcium, parathyroid
hormone, iron, ferritin, transferrin coefficient, iron saturation, folic acid,
vitamin B1, B6, B12, vitamin D),
Anaemia (measured by haemoglobuline),
Pancreatic activity (measured by fecal elastase in the 24h stools).,
Dumping syndrome (measured using the Arts Dumping Scale),
Gastro-esophageal reflux (measured using the GERD-Q questionnaire)
Background summary
Morbid obesity remains a major health care burden all over the world. Multiple
treatments for obesity are in use, but bariatric surgery seems to be the most
cost-effective procedure(1)(2)(3)(4). A recent study of Wu et al. showed that
bariatric surgery was effective in reducing weight, remission of type 2
diabetes and showed improvements on dyslipidaemia(5), furthermore other studies
implied a reduction in 10-year cardiovascular disease risk(6)(7).
The IFSO reported that from 2015-2018, sleeve gastrectomy was the most
performed bariatric procedure worldwide with 58.6%, followed by Roux-en-Y
gastric bypass (RYGB)(31.2%). However, in the Netherlands the most performed
bariatric surgery remains the RYGB(8). The mini gastric bypass (MGB) or the one
anastomosis gastric bypass (OAGB) gains ground (9)(10). OAGB works in a similar
manner as RYGB due to both restriction and malabsorption and complex metabolic
effects. Benefits of OAGB in comparison to RYGB are a shorter operating
time(11) , a possible difficulty reduction and shorter learning curve(12)(13)
and overall technically less demanding in rare reversal procedures(14). Also
there are signs that weight loss is greater in the OAGB group(11)(15)(16)
comparing it to RYGB with substantial different biliopancreatic limb lengths.
Finally, with OAGB there is a smaller chance on internal herniation and bowel
obstruction(15).
Despite these advantages controversies remain about the OAGB procedure. One
issue is about the risk on malnutrition and nutritional deficiencies, since
multiple studies found adverse events in the form of nutritional
complications(11)(17), especially when the biliopancreatic limb (BPL) is 200cm
or longer(17). The severity of these nutritional complications -such as
excessive weight loss, vitamin deficiency and anaemia- depends on the length
of the BPL: a longer BPL induces a higher chance on nutritional
complications(17)(18)(19).
Another big worry is about biliary reflux and the chance on developing
gastro-oesophageal cancer(20)(21). It has been shown in an experiment with
obese rats who have undergone an OAGB that biliary reflux was present. When
biopsies were taken from their gastric cardias, a significant increase of
eosinophilic polynuclear cell infiltration was found in comparison to the sham
rats(22). Nevertheless, no metaplasia, dysplasia or cancer has been observed.
Recently a multicentre RCT (YOMEGA) was set up by Robert et al. to compare OAGB
with RYGB. 234 patients were assigned (1:1) either to the OAGB group or to the
RYGB group. Lengths of the limbs were set on a 200cm BPL for the OAGB group and
a 50cm BPL and a 150cm Roux-limb in the RYGB group. The study confirmed
non-inferiority of OAGB considering percentage excess BMI loss (%EBMIL) after
two years. The YOMEGA trial reported 66 serious adverse events associated with
surgery (24 in the RYGB group vs. 42 in the OAGB group; p=0.042), of which nine
(21.4%) in the OAGB group were nutritional complications versus none in the
RYGB group (p=0.0034).
In 2017 already, K. Mahawar advised against the length of BPL in OAGB to be
>150cm, because of the chance on serious malnutrition(23), later-on findings
confirmed similar weight loss in OAGB with a BPL of 150cm vs. 200 cm, without
extra risk of malnutrition (24).
Because of the combination of all the results mentioned above, a
non-inferiority randomized controlled trial will be performed, comparing an
OAGB consisting of a 150cm BPL length with an RYGB consisting of a 150cm BPL
length and a 50-75cm Roux-limb: comparing apples with apples.
Study objective
The objective of this study is to find out whether a 150cm BPL-length OAGB is
just as good in treating morbidly obese adults when compared to a 150cm
BPL-length RYGB with a 75cm Roux-limb in terms of percentage excess BMI loss
and nutritional adverse effects after two years.
Study design
prospective non-inferiority randomized controlled trial
Intervention
OAGB (compared with normal RYGB treatment, 1:1)
Study burden and risks
No higher risk is suspected in comparison to regular treatment (RYGB), except
for possible biliary reflux and its possible consequence (revision surgery).
Hospitaalweg 1
Almere 1315RA
NL
Hospitaalweg 1
Almere 1315RA
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are BMI >40kg/m2, or BMI >35kg/m2 with at least one of the
following comorbidities: type 2 diabetes, hypertension, dyslipidaemia,
obstructive sleep apnoea, or osteoarthritis of the hip or knee; age 18-65
years; positive evaluation by a Bariatric multidisciplinary team (BMDT,
consisting of psychologists, dietitians, internists and bariatric surgeons);
and written informed consent
Exclusion criteria
Exclusion criteria will be presence of Helicobacter pylori resistant to
eradication therapy, the presence of chronic diarrhoea, or previous bariatric
or extensive abdominal surgery.
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 | NL74137.018.20 |