In this single-blinded randomized controlled trial the investigators aim to compare the OAGB and the EPGB in terms of percentage total weight loss (%TWL) 1 and 3 years postoperatively, postoperative complications and comorbidity remission in…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal therapeutic procedures
Synonym
Health condition
obesitas, bariatrische chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage total weight loss (%TWL) 1 and 3 years postoperatively.
Secondary outcome
%TWL 6 months, 2 years and 5 years postoperatively, percentage excess weight
loss (%EWL) 6 months, 1 year, 2 years, 3 years and 5 years postoperatively,
complications short term (bleeding, anastomotic leakage, anastomotic stenosis,
wound infection, intra-abdominal abscess, re-intervention, reoperation,
readmission, mortality) according to Clavien-Dindo classification,
complications long term (vitamin/electrolyte deficiencies, internal herniation,
marginal ulceration, revision) according to Clavien-Dindo classification,
comorbidity remission, reflux, dumping, quality of life (QoL), intraoperative
complications according to Clavien-Dindo classification, intraoperative
conversion to sleeve.
Background summary
The laparoscopic Roux-en-Y gastric bypass (LRYGB) is a successful surgical
treatment for patients with morbid obesity that has been performed for more
than 40 years. Two alternative operation techniques that gained more interest
over the last several years are the extended pouch gastric bypass (EPGB) and
the one anastomosis gastric bypass (OAGB). Literature shows that both
techniques seem to be adequate alternatives for the LRYGB and some studies are
even advocating that the EPGB improves mid-term weight loss when compared to
the LRYGB, potentially driven by a lower occurrence of weight regain. Both the
EPGB and the OAGB use an extended gastric pouch, which probably makes it
technically easier to create the gastrojejunostomy in patients with a higher
BMI, because less traction on the small intestine and the mesentery is needed
to reach the level of the pouch. The most important differ-ence between the
EPGB and the OAGB is that there is also a jejunojejunostomy created in the
EPGB. As of yet, there is no evidence that this second anastomosis created in
the EPGB is necessary since both techniques have not been compared one to one
in a prospective randomized controlled trial.
Study objective
In this single-blinded randomized controlled trial the investigators aim to
compare the OAGB and the EPGB in terms of percentage total weight loss (%TWL) 1
and 3 years postoperatively, postoperative complications and comorbidity
remission in patients with a higher BMI (>=45).
Study design
A multicenter single-blinded randomized controlled trial.
Intervention
A total of 104 participants will be randomized over two treatment groups:
- Group A will undergo the EPGB: an extended pouch gastric bypass with two
anastomoses, a gastric pouch of 12-15cm, a biliopancreatic limb of 150cm and an
alimentary limb of 100cm.
- Group B will undergo the OAGB: an extended pouch gastric bypass with one
anastomosis, an extended pouch of 12-15cm and a biliopancreatic limb of 150cm.
Study burden and risks
Both procedures are considered as adequate alternatives for the LRYGB.
Therefore, there are no additional risks associated with this treatment.
Additionally, participants will be asked to fill out online questionnaires
regarding reflux and dumping complaints, quality of life and patient
satisfaction of procedure. These questionnaires are considered as low burden.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
• Age 18-65 years;
• BMI >=45 kg/m2;
• Eligible for LRYGB;
• Dedication to guided preoperative program;
• Intention to follow full postoperative program.
Exclusion criteria
• Secondary bariatric procedure;
• Preoperative use of proton pomp inhibitors (PPIs) for gastroesophageal reflux
disease (GERD);
• Medical(-related) cause for morbid obesity or fast weight gain (e.g. Cushing
or medication related);
• Inflammatory Bowel Disease (M. Crohn or Colitis Ulcerosa), celiac disease,
irritable bowel syndrome and other causes of chronic diarrhea;
• Renal function disorder (MDRD <30) or liver disease;
• Anticipated absence of follow up program;
• Inability of reading/understanding and filling out questionnaires;
• Pregnant women.
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT06204939 |
| CCMO | NL87855.100.25 |