One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Other: RYGB; Other: OAGB/MGB

• Registration Number: NCT03045679
• Lead Sponsor: Sana Klinikum Offenbach

Brief Summary

The aim of this prospective randomized controlled trial is to compare the two procedures One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass (RYGB) in relation to intraoperative and postoperative complications (classification of Clavien-Dindo), mortality, metabolic impact (remission of type 2 diabetes mellitus, hypertonus, gastro-esophageal reflux disease, sleep apnea, dyslipidemia, quality of life, operation time, postoperative excess weight loss, malnutrition and re-do/revisonal surgery.

Detailed Description

OAGB/MGB is gaining popularity as a primary surgical treatment for morbid obesity due to reduced operation time, a shorter learning curve, better weight loss, higher metabolic impact and fewer major complications compared to RYGB.

In this prospective randomized controlled trial we want to compare OAGB/MGB and RYGB with a FU of up to 24 month.

Patients with indication for gastric bypass get randomized in group A (RYGB, n = 50) or B (OAGB/MGB, n = 50). FU is performed 1, 3, 6, 12 and 24 month after surgery.

Study Timeline

• Study First Submitted: 2017-02-05
• Study First Submitted QC: 2017-02-05
• Study First Posted: 2017-02-07
• Study Start: 2018-01-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. primary obesity surgery and indication for gastric bypass
2. age: 18 - 65 years
3. BMI > 40 kg/m² or BMI > 35 kg/m² with obesity related comorbidities
4. informed consent

Exclusion Criteria

1. obesity surgery in the anamnesis
2. visceral surgery in the anamnesis (excluding appendectomy and cholecystectomy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RYGB-group	RYGB	Patients who undergo laparoscopic RYGB (150 cm alimentary limb, 50 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50
OAGB/MGB-group	OAGB/MGB	Patients who undergo laparoscopic OAGB/MGB (200 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50

Primary Outcome Measures

Name	Time	Method
complications	up to 2 years after surgery	complications classified next to Clavien-Dindo

Secondary Outcome Measures

Name	Time	Method
quality of life questionnaire	up to 2 years after surgery	changing in quality of life measured by questionnaire
weight loss	up to 2 years after surgery	postoperative excess weight loss in %
operation time	operation time during surgery in minutes	operation time during surgery in minutes
remission of type 2 diabetes mellitus	up to 2 years after surgery	HbA1c \< 6.5% without medication
gastro-esophageal reflux disease	up to 2 years after surgery	GERD-HRGL Heartburn Scale
malnutrition 3	up to 2 years after surgery	postoperative malnutrition: ferritin (\< 30 µg/l)
malnutrition 4	up to 2 years after surgery	postoperative malnutrition: vitamin E \< 12 µmol/l
mortality	up to 2 years after surgery	death up to 2 years after surgery
remission of sleep apnea	up to 2 years after surgery	presence/absence of CPAP
remission of hypercholesterinemia	up to 2 years after surgery	cholesterin \< 155 mg/dl without medication
malnutrition 2	up to 2 years after surgery	postoperative malnutrition: albumin \< 35 g/l
remission of hypertonus	up to 2 years after surgery	blood pressure \< 140/90 mmHg without medication
malnutrition 1	up to 2 years after surgery	postoperative malnutrition: protein \< 64 g/l
malnutrition 5	up to 2 years after surgery	postoperative malnutrition: vitamin K \< 90 ng/l
revisional surgery	up to 2 years after surgery	revisional surgery during follow up
remission of hypertrigliceridemia	up to 2 years after surgery	triglyceride \< 200mg/dl without medication
malnutrition 6	up to 2 years after surgery	postoperative malnutrition: vitamin 25-OH- Vitamin D3 \< 50 nmol/l
malnutrition 8	up to 2 years after surgery	postoperative malnutrition: vitamin B12 \< 145 pmol/l
malnutrition 7	up to 2 years after surgery	postoperative malnutrition: vitamin A \< 1.05 µmol/l

Trial Locations

Locations (1)

Sana Klinikum Offenbach; 🇩🇪 Offenbach, Hessen, Germany