Morbid ObesityRYSANCT02882685
Comparison of Mini Gastric Bypass and Roux-en-Y Gastric Bypass
A study testing Roux-en-y gastric bypass and Single anastomosis gastric bypass in people with Morbid Obesity, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Roux-en-y gastric bypass and Single anastomosis gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesFinland
- Study dates
- Jul 2016to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI>35
Who cannot join
- Pregnancy
- Previous bariatric surgery
- Anemia
- esophagitis (LA B-D)
- esophageal intestinal metaplasia
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Central Hospital
Helsinki, 00029
Oulu University Hospital
Oulu
About this study
Official title: Comparison of Two Operative Techniques - Mini Gastric Bypass and Roux-en-Y Gastric Bypass in the Treatment of Severe Obesity
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.
Read the detailed description
Roux-en-Y gastric bypass (RYGB) and single anastomosis gastric bypass (SAGB or mini gastric bypass, MGB) have both shown excellent weight-loss and effect on comorbidities such as type 2 diabetes.
In this study eligible patients are randomized for either of the operations. Effects on glucose homeostasis as well as weight-loss and the effect on comorbidities are recorded during the follow-up.
Before the surgery and at 6 and 12 months, all participants will undergo body composition measurements (bioimpedance, MRI and DEXA), mixed meal tests and oral glucose tolerance tests, calorimetry and biopsies of skin, subcutaneous fat and muscle will be obtained and samples of urine, feces and saliva are collected. At these timepoints, all patients will fill out questionnaires regarding psychocological, social and physical health and wellbeing.
Interim analysies will be done for the first 60 patients (30 per group) after 3 months, in which safety issues and trial setup is reviewed. If there are no problems with safety and setup, the trial can be carried out according to initial plan.
At 12 months, all outcomes for all patients will be analyzed. Main outcome is weight-loss one year after the surgery.
Follow-up continues at 24months, 5 years and 10 years after the surgery and follow-up data will be analyzed accordingly.
Also, MGB has been feared to cause bile reflux. The first 30 MGB patients will undergo a gastroscopy and a hepatobiliary scintigraphy for bile reflux detection at 6 months.
- Conditions
- Morbid Obesity
- Being tested
- Roux-en-y gastric bypass, Single anastomosis gastric bypass
- Keywords
- Roux-en-Y gastric bypass, Mini-gastric bypass, Single anastomosis gastric bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-y gastric bypassProcedure or surgery
Also called RYGB
Single anastomosis gastric bypassProcedure or surgery
Also called SAGB, Mini-gastric bypass, MGB
| Study group | Role | What they receive |
|---|---|---|
| RYGB | Active comparator | Roux-en-Y gastric bypass Receives: Procedure: Roux-en-y gastric bypass |
| SAGB | Active comparator | Single anastomosis gastric bypass Receives: Procedure: Single anastomosis gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (3)
Glucose homeostasis
2 months before the operation glucose homeostasis status is studied (oral glucose tolerance test). Oral glucose tolerance tests will be repeated at 6months and 12 months. Continuos glucose monitoring will be done before the operation at operation and 6 months after the operation
Measured: Up to 12 months
Bile reflux after Mini Gastric Bypass
All patients undergo a gastroscopy prior to inclusion. Patients with Barrets esophagus or LA B-C esophagitis are excluded. The first 30 patients, who are randomized to Mini Gastric Bypass will undergo a gastroscopy and a hepatobiliary scintigraphy 6 months after the operation. At hepatobiliary scintigraphy the amount of bile reflux is calculated as the amount of tracer found in the gastric pouch or esophagus in relation to total amount of tracer in the liver.
Measured: 6 months
Weight-loss
Weight-loss at 2years, 5years and 10 years
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuure Saarinen, Helsinki University Central Hospital
- Investigators
- Tuure T Saarinen, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882685
- Sponsor's protocol ID
- HUS214/2016
- Acronym
- RYSA
- Status last verified
- Jul 2022
- First submitted
- 23 Jul 2016
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 41507695Heinonen S, Karppinen JE, Saarinen T, Groop PH, Juuti A, Holst JJ, Pietilainen KH. Greater early postprandial GLP-1 increase after Roux-en-Y than one-anastomosis gastric bypass, with unchanged secretin: a randomized controlled trial. Int J Obes (Lond). 2026 May;50(5):1015-1026. doi: 10.1038/s41366-025-02000-3. Epub 2026 Jan 6.
PubMed 41495448Janis M, Saarinen T, Karppinen JE, Groop PH, Neuvonen M, Niemi M, Juuti A, Pietilainen KH, Heinonen S. Distinct fasting and postprandial bile acid responses following Roux-en-Y and one-anastomosis gastric bypass. Int J Obes (Lond). 2026 May;50(5):1005-1014. doi: 10.1038/s41366-025-01999-9. Epub 2026 Jan 5.
PubMed 41486179Saarinen 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.
PubMed 31888729Saarinen 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.
PubMed 31853864
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Operative Techniques - Mini Gastric Bypass and Roux-en-Y Gastric Bypass in the Treatment of Severe Obesity
- ClinicalTrials.gov ID
- NCT02882685
- Acronym / sponsor ID
- RYSA / HUS214/2016
- Conditions
- Morbid Obesity
- Keywords
- Roux-en-Y gastric bypass, Mini-gastric bypass, Single anastomosis gastric bypass
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Roux-en-Y gastric bypass (RYGB) and single anastomosis gastric bypass (SAGB or mini gastric bypass, MGB) have both shown excellent weight-loss and effect on comorbidities such as type 2 diabetes.
In this study eligible patients are randomized for either of the operations. Effects on glucose homeostasis as well as weight-loss and the effect on comorbidities are recorded during the follow-up.
Before the surgery and at 6 and 12 months, all participants will undergo body composition measurements (bioimpedance, MRI and DEXA), mixed meal tests and oral glucose tolerance tests, calorimetry and biopsies of skin, subcutaneous fat and muscle will be obtained and samples of urine, feces and saliva are collected. At these timepoints, all patients will fill out questionnaires regarding psychocological, social and physical health and wellbeing.
Interim analysies will be done for the first 60 patients (30 per group) after 3 months, in which safety issues and trial setup is reviewed. If there are no problems with safety and setup, the trial can be carried out according to initial plan.
At 12 months, all outcomes for all patients will be analyzed. Main outcome is weight-loss one year after the surgery.
Follow-up continues at 24months, 5 years and 10 years after the surgery and follow-up data will be analyzed accordingly.
Also, MGB has been feared to cause bile reflux. The first 30 MGB patients will undergo a gastroscopy and a hepatobiliary scintigraphy for bile reflux detection at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RYGB | Active comparator | Procedure: Roux-en-y gastric bypassRoux-en-Y gastric bypass |
| SAGB | Active comparator | Procedure: Single anastomosis gastric bypassSingle anastomosis gastric bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI>35
Key exclusion criteria (5 listed)
- Pregnancy
- Previous bariatric surgery
- Anemia
- esophagitis (LA B-D)
- esophageal intestinal metaplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-y gastric bypassAlso: RYGB | Procedure or surgery | RYGB |
| Single anastomosis gastric bypassAlso: SAGB, Mini-gastric bypass, MGB | Procedure or surgery | SAGB |
Primary outcome
Weight-loss
Time frame: One year
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.
3 secondary outcomes
Glucose homeostasis
Time frame: Up to 12 months
Bile reflux after Mini Gastric Bypass
Time frame: 6 months
Weight-loss
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 41507695van 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.
- Derived from this study: PubMed 41495448Heinonen S, Karppinen JE, Saarinen T, Groop PH, Juuti A, Holst JJ, Pietilainen KH. Greater early postprandial GLP-1 increase after Roux-en-Y than one-anastomosis gastric bypass, with unchanged secretin: a randomized controlled trial. Int J Obes (Lond). 2026 May;50(5):1015-1026. doi: 10.1038/s41366-025-02000-3. Epub 2026 Jan 6.
- Derived from this study: PubMed 41486179Janis M, Saarinen T, Karppinen JE, Groop PH, Neuvonen M, Niemi M, Juuti A, Pietilainen KH, Heinonen S. Distinct fasting and postprandial bile acid responses following Roux-en-Y and one-anastomosis gastric bypass. Int J Obes (Lond). 2026 May;50(5):1005-1014. doi: 10.1038/s41366-025-01999-9. Epub 2026 Jan 5.
- Derived from this study: PubMed 31888729Saarinen 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.
- Derived from this study: PubMed 31853864Saarinen 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.
- Individual participant dataSharing planned: No
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuure T Saarinen, MD principal investigator
Helsinki University Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-y gastric bypass and Single anastomosis gastric bypass in people with Morbid Obesity, run by Helsinki University Central Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight-loss (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02882685, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.