NCT02882685

Brief Summary

This study compares Roux-en-Y gastric bypass with single anastomosis gastric bypass in a randomized prospective setting. This study also adresses the issue of bile reflux after MGB.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2016Dec 2026

Study Start

First participant enrolled

July 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

6.4 years

First QC Date

July 23, 2016

Last Update Submit

July 18, 2022

Conditions

Morbid Obesity

Keywords

Roux-en-Y gastric bypassMini-gastric bypassSingle anastomosis gastric bypass

Outcome Measures

Primary Outcomes (1)

  • Weight-loss

    Main outcome is weight-loss at 1 yewar after the operationoperation. Weight-loss is calculated as excess weight-loss compared to the preoperative weight 2 months before the operation.

    One year

Secondary Outcomes (3)

  • Glucose homeostasis

    Up to 12 months

  • Bile reflux after Mini Gastric Bypass

    6 months

  • Weight-loss

    10 years

Study Arms (2)

RYGB

ACTIVE COMPARATOR

Roux-en-Y gastric bypass

Procedure: Roux-en-y gastric bypass

SAGB

ACTIVE COMPARATOR

Single anastomosis gastric bypass

Procedure: Single anastomosis gastric bypass

Interventions

Roux-en-y gastric bypassPROCEDURE
Also known as: RYGB
RYGB
Single anastomosis gastric bypassPROCEDURE
Also known as: SAGB, Mini-gastric bypass, MGB
SAGB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI\>35

You may not qualify if:

  • Pregnancy
  • Previous bariatric surgery
  • Anemia
  • esophagitis (LA B-D)
  • esophageal intestinal metaplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Related Publications (3)

  • van der Kolk BW, Heinonen S, White JW, Wagner A, Karppinen JE, Saari S, Muniandy M, Metsikko S, Dillon ET, Groop PH, Saarinen T, Le Roux CW, Virtanen KA, Docherty NG, Pirinen E, Juuti A, Pietilainen KH. Human Skeletal Muscle Mitochondria Responses to Weight Loss Induced by Bariatric Surgery or Lifestyle Intervention. Acta Physiol (Oxf). 2026 Feb;242(2):e70150. doi: 10.1111/apha.70150.

    PMID: 41507695DERIVED

  • Saarinen T, Merilainen S, Koivukangas V, Pietilainen KH, Juuti A. Prospective randomized controlled trial comparing the efficacy and safety of Roux-en-Y gastric bypass and one-anastomosis gastric bypass (the RYSA trial): trial protocol and interim analysis. Trials. 2019 Dec 30;20(1):803. doi: 10.1186/s13063-019-3898-y.

    PMID: 31888729DERIVED

  • Saarinen T, Pietilainen KH, Loimaala A, Ihalainen T, Sammalkorpi H, Penttila A, Juuti A. Bile Reflux is a Common Finding in the Gastric Pouch After One Anastomosis Gastric Bypass. Obes Surg. 2020 Mar;30(3):875-881. doi: 10.1007/s11695-019-04353-x.

    PMID: 31853864DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Tuure T Saarinen, MD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 23, 2016

First Posted

August 30, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2022

Study Completion (Estimated)

December 1, 2026

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FI(2)