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Effect of restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a prospective randomized control trial

Effect of restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a prospective randomized control trial - The Extended Pouch Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44889
Enrollment
134
Registered
2014-01-24
Start date
2014-08-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbide obesitas Morbidobesity overweight

Interventions

Standard RYGB with a 40-50cc pouch versus an extended pouch in RYGB.

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age between 18 and 60 years - BMI >40 kg/m2 without comorbidities - BMI >35 and

Exclusion criteria

Exclusion criteria: - Mental disorder, psychotic disorders, severe depression and personality disorders - Never had professional medical guidance with weight loss - Not able to participate in long-term medical checks - Alcohol or drug abuse - Diseases that form a threat on life expectancy on the short term of perioperative - Patients who can not take care for themselfs, or pateint who do not have any social network to take this responsibility - Bariatric surgery in the medical history - Patients with a language barrier which can have affect on medical follow up and treatment - Any kind of genetic disorders which can be of influence on medical advice - Patients with a disease not related to morbid obesity , eg Cushing or medication related - Chronic bowel diseases; eg M. Crohn or Colitis Collitis - Renal impairment ( MDRD

Design outcomes

Primary

MeasureTime frame
Weight reduction; total body weight loss (%TBWL) and excess weight loss (%EWL)

Secondary

MeasureTime frame
a. decrease in comorbidities: diabetes mellitus, hypertension, hypercholesterolemia, artrosis b. quality of life: SF-36 and BAROS c. Complications and re-operations: bleeding, woundinfections, intra-abdominal abces, anastomotic leakage, vitamin deficiencies, reflux

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)