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One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass (MGBvsRYGB)

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ClinicalTrials.gov Identifier: NCT03045679
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Sonja Chiappetta, MD, 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.

Condition or disease Intervention/treatment Phase
Obesity Other: RYGB Other: OAGB/MGB Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomized controlled trial: RYGB (group A) vs OAGB/MGB (group B)
Masking: Single (Investigator)
Masking Description: envelope randomization
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Experimental: RYGB-group
Patients who undergo laparoscopic RYGB (150 cm alimentary limb, 50 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50
Other: RYGB
laparoscopic RYGB

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




Primary Outcome Measures :
  1. complications [ Time Frame: up to 2 years after surgery ]
    complications classified next to Clavien-Dindo


Secondary Outcome Measures :
  1. mortality [ Time Frame: up to 2 years after surgery ]
    death up to 2 years after surgery

  2. remission of type 2 diabetes mellitus [ Time Frame: up to 2 years after surgery ]
    HbA1c < 6.5% without medication

  3. remission of hypertonus [ Time Frame: up to 2 years after surgery ]
    blood pressure < 140/90 mmHg without medication

  4. gastro-esophageal reflux disease [ Time Frame: up to 2 years after surgery ]
    GERD-HRGL Heartburn Scale

  5. remission of sleep apnea [ Time Frame: up to 2 years after surgery ]
    presence/absence of CPAP

  6. remission of hypertrigliceridemia [ Time Frame: up to 2 years after surgery ]
    triglyceride < 200mg/dl without medication

  7. remission of hypercholesterinemia [ Time Frame: up to 2 years after surgery ]
    cholesterin < 155 mg/dl without medication

  8. quality of life questionnaire [ Time Frame: up to 2 years after surgery ]
    changing in quality of life measured by questionnaire

  9. weight loss [ Time Frame: up to 2 years after surgery ]
    postoperative excess weight loss in %

  10. operation time [ Time Frame: operation time during surgery in minutes ]
    operation time during surgery in minutes

  11. malnutrition 1 [ Time Frame: up to 2 years after surgery ]
    postoperative malnutrition: protein < 64 g/l

  12. malnutrition 2 [ Time Frame: up to 2 years after surgery ]
    postoperative malnutrition: albumin < 35 g/l

  13. malnutrition 3 [ Time Frame: up to 2 years after surgery ]
    postoperative malnutrition: ferritin (< 30 µg/l)

  14. malnutrition 4 [ Time Frame: up to 2 years after surgery ]
    postoperative malnutrition: vitamin E < 12 µmol/l

  15. malnutrition 5 [ Time Frame: up to 2 years after surgery ]
    postoperative malnutrition: vitamin K < 90 ng/l

  16. malnutrition 6 [ Time Frame: up to 2 years after surgery ]
    postoperative malnutrition: vitamin 25-OH- Vitamin D3 < 50 nmol/l

  17. malnutrition 7 [ Time Frame: up to 2 years after surgery ]
    postoperative malnutrition: vitamin A < 1.05 µmol/l

  18. malnutrition 8 [ Time Frame: up to 2 years after surgery ]
    postoperative malnutrition: vitamin B12 < 145 pmol/l

  19. revisional surgery [ Time Frame: up to 2 years after surgery ]
    revisional surgery during follow up



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045679


Contacts
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Contact: Sonja Chiappetta, MD 0049 69 8405 1700 sonja1002@gmx.de

Locations
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Germany
Sana Klinikum Offenbach Recruiting
Offenbach, Hessen, Germany, 63069
Contact: Sonja Chiappetta, MD    00496984051706    sonja1002@gmx.de   
Sponsors and Collaborators
Sana Klinikum Offenbach
Investigators
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Study Chair: Sonja Chiappetta, MD Sana Klinikum Offenbach

Publications of Results:
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Responsible Party: Sonja Chiappetta, MD, Principal investigator: Dr. Sonja Chiappetta, Sana Klinikum Offenbach
ClinicalTrials.gov Identifier: NCT03045679    
Other Study ID Numbers: FF 74/2016
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sonja Chiappetta, MD, Sana Klinikum Offenbach:
Roux-en Y gastric bypass
One-anastomosis gastric bypass
Mini-gastric bypass
metabolic surgery