## Protocol Section
### Identification Module
**NCT ID:** NCT03045679

**Acronym:** MGBvsRYGB

**Brief Title:** One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass

**Official Title:** The Evidence of One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass in Metabolic Surgery - a Prospective Randomized Controlled Trial

#### Organization Study ID Info
**ID:** FF 74/2016
#### Organization
**Class:** OTHER
**Full Name:** Sana Klinikum Offenbach
### Status Module
#### Completion Date
**Date:** 2020-12-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-01-17

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-13

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2020-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2018-01-01

**Type:** ACTUAL

**Status Verified Date:** 2023-01

#### Study First Post Date
**Date:** 2017-02-07
**Type:** ESTIMATED
**Study First Submit Date:** 2017-02-05
**Study First Submit QC Date:** 2017-02-05
**Why Stopped:** Hospital changed in 2019, no recruitment performed
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sana Klinikum Offenbach

#### Responsible Party

**Investigator Affiliation:** Sana Klinikum Offenbach

**Investigator Full Name:** Sonja Chiappetta, MD

**Investigator Title:** Principal investigator: Dr. Sonja Chiappetta

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Obesity

**Keywords:**

- Roux-en Y gastric bypass

- One-anastomosis gastric bypass

- Mini-gastric bypass

- metabolic surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** prospective randomized controlled trial: RYGB (group A) vs OAGB/MGB (group B)

##### Masking Info

**Masking:** SINGLE

**Masking Description:** envelope randomization

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients who undergo laparoscopic RYGB (150 cm alimentary limb, 50 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50

**Intervention Names:**

- Other: RYGB

**Label:** RYGB-group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients who undergo laparoscopic OAGB/MGB (200 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50

**Intervention Names:**

- Other: OAGB/MGB

**Label:** OAGB/MGB-group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- RYGB-group

**Description:** laparoscopic RYGB

**Name:** RYGB

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- OAGB/MGB-group

**Description:** laparoscopic OAGB/MGB

**Name:** OAGB/MGB

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** complications classified next to Clavien-Dindo

**Measure:** complications

**Time Frame:** up to 2 years after surgery

#### Secondary Outcomes

**Description:** death up to 2 years after surgery

**Measure:** mortality

**Time Frame:** up to 2 years after surgery

**Description:** HbA1c \< 6.5% without medication

**Measure:** remission of type 2 diabetes mellitus

**Time Frame:** up to 2 years after surgery

**Description:** blood pressure \< 140/90 mmHg without medication

**Measure:** remission of hypertonus

**Time Frame:** up to 2 years after surgery

**Description:** GERD-HRGL Heartburn Scale

**Measure:** gastro-esophageal reflux disease

**Time Frame:** up to 2 years after surgery

**Description:** presence/absence of CPAP

**Measure:** remission of sleep apnea

**Time Frame:** up to 2 years after surgery

**Description:** triglyceride \< 200mg/dl without medication

**Measure:** remission of hypertrigliceridemia

**Time Frame:** up to 2 years after surgery

**Description:** cholesterin \< 155 mg/dl without medication

**Measure:** remission of hypercholesterinemia

**Time Frame:** up to 2 years after surgery

**Description:** changing in quality of life measured by questionnaire

**Measure:** quality of life questionnaire

**Time Frame:** up to 2 years after surgery

**Description:** postoperative excess weight loss in %

**Measure:** weight loss

**Time Frame:** up to 2 years after surgery

**Description:** operation time during surgery in minutes

**Measure:** operation time

**Time Frame:** operation time during surgery in minutes

**Description:** postoperative malnutrition: protein \< 64 g/l

**Measure:** malnutrition 1

**Time Frame:** up to 2 years after surgery

**Description:** postoperative malnutrition: albumin \< 35 g/l

**Measure:** malnutrition 2

**Time Frame:** up to 2 years after surgery

**Description:** postoperative malnutrition: ferritin (\< 30 µg/l)

**Measure:** malnutrition 3

**Time Frame:** up to 2 years after surgery

**Description:** postoperative malnutrition: vitamin E \< 12 µmol/l

**Measure:** malnutrition 4

**Time Frame:** up to 2 years after surgery

**Description:** postoperative malnutrition: vitamin K \< 90 ng/l

**Measure:** malnutrition 5

**Time Frame:** up to 2 years after surgery

**Description:** postoperative malnutrition: vitamin 25-OH- Vitamin D3 \< 50 nmol/l

**Measure:** malnutrition 6

**Time Frame:** up to 2 years after surgery

**Description:** postoperative malnutrition: vitamin A \< 1.05 µmol/l

**Measure:** malnutrition 7

**Time Frame:** up to 2 years after surgery

**Description:** postoperative malnutrition: vitamin B12 \< 145 pmol/l

**Measure:** malnutrition 8

**Time Frame:** up to 2 years after surgery

**Description:** revisional surgery during follow up

**Measure:** revisional surgery

**Time Frame:** up to 2 years after surgery

### Eligibility Module

**Eligibility Criteria:** 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)

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Offenbach

**Country:** Germany

**Facility:** Sana Klinikum Offenbach

**State:** Hessen

**Zip:** 63069

#### Overall Officials

**Official 1:**

**Affiliation:** Sana Klinikum Offenbach

**Name:** Sonja Chiappetta, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Chevallier JM, Arman GA, Guenzi M, Rau C, Bruzzi M, Beaupel N, Zinzindohoue F, Berger A. One thousand single anastomosis (omega loop) gastric bypasses to treat morbid obesity in a 7-year period: outcomes show few complications and good efficacy. Obes Surg. 2015 Jun;25(6):951-8. doi: 10.1007/s11695-014-1552-z.

**PMID:** 25585612

**Citation:** Jammu GS, Sharma R. A 7-Year Clinical Audit of 1107 Cases Comparing Sleeve Gastrectomy, Roux-En-Y Gastric Bypass, and Mini-Gastric Bypass, to Determine an Effective and Safe Bariatric and Metabolic Procedure. Obes Surg. 2016 May;26(5):926-32. doi: 10.1007/s11695-015-1869-2.

**PMID:** 26337694

**Citation:** Musella M, Apers J, Rheinwalt K, Ribeiro R, Manno E, Greco F, Cierny M, Milone M, Di Stefano C, Guler S, Van Lessen IM, Guerra A, Maglio MN, Bonfanti R, Novotna R, Coretti G, Piazza L. Efficacy of Bariatric Surgery in Type 2 Diabetes Mellitus Remission: the Role of Mini Gastric Bypass/One Anastomosis Gastric Bypass and Sleeve Gastrectomy at 1 Year of Follow-up. A European survey. Obes Surg. 2016 May;26(5):933-40. doi: 10.1007/s11695-015-1865-6.

**PMID:** 26341086

**Citation:** Guenzi M, Arman G, Rau C, Cordun C, Moszkowicz D, Voron T, Chevallier JM. Remission of type 2 diabetes after omega loop gastric bypass for morbid obesity. Surg Endosc. 2015 Sep;29(9):2669-74. doi: 10.1007/s00464-014-3987-7. Epub 2015 Jan 1.

**PMID:** 25552228

**Citation:** Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. doi: 10.1097/01.sla.0000167762.46568.98.

**PMID:** 15973097

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
