ObesityNCT00821197
Long-limb or Distal Gastric Bypass for Superobesity - Randomized Study
A study testing long-limb gastric bypass and distal gastric bypass in people with Obesity, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The main study objective: To evaluate long-limb gastric bypass (150 cm alimentary limb) vs. "distal" gastric bypass (common channel 150 cm) in the treatment of superobesity (BMI 50-60 kg/m2). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- long-limb gastric bypass and distal gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2011to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 50 - 60 kg/m2 at admission for evaluation for bariatric surgery
- BMI 48 - 62 kg/m2 at study inclusion
- informed consent
- scheduled for bariatric surgery
Who cannot join
- previous bariatric surgery
- previous major abdominal surgery
- previous history or established urolithiasis
- viral hepatitis, liver cirrhosis of any kind
- factors making the patient not eligible to understand and commit to the study protocol (severe psychiatric disease or drug/narcotic abuse)
Trial locations and contacts
1 site in 1 country.
Norway1 site
Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.
Oslo, 0514
About this study
Official title: Long -Limb Gastric or Distal Gastric Bypass in the Treatment of Super Obese Patients - a Prospective Randomized Study
The main study objective:
To evaluate long-limb gastric bypass (150 cm alimentary limb) vs. "distal" gastric bypass (common channel 150 cm) in the treatment of superobesity (BMI 50-60 kg/m2).
The main study hypothesis:
Distal bypass accomplish an estimated 10-20 % larger weightloss than long-limb gastric bypass 1 year after surgery. Patients subject to distal bypass have more gastrointestinal side effects and more extensive nutritional deficiences compared to long-limb gastric bypass.
Read the detailed description
Technical data will later be published in detail
- Conditions
- Obesity
- Being tested
- long-limb gastric bypass, distal gastric bypass
- Keywords
- obesity, laparoscopy, bariatric, super obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long-limb gastric bypassProcedure or surgery
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
distal gastric bypassProcedure or surgery
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)
| Study group | Role | What they receive |
|---|---|---|
| long-limb bypass | Active comparator | Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb) Receives: Procedure: long-limb gastric bypass |
| Distal gastric bypass | Active comparator | Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb) Receives: Procedure: distal gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: weight loss
physical examination
Measured: 2 years postoperatively
Secondary outcomes (17)
Secondary outcome: Quality of life
questionnaire
Measured: 2 years postoperative
Adverse events
medical history, journals
Measured: 2 years postoperative
Number of patients with vitamin deficiencies
Blood samples
Measured: 2 years postoperative
Number of patients with mineral deficiencies
Blood samples
Measured: 2 years postoperative
Number of participants with malnutrition
Blood samples
Measured: 2 years postoperative
Weight loss 5 year
physical examination
Measured: 5 year postoperative
Health related Quality of life
questionnaire
Measured: 5 years postoperative
Number of patients with malnutrition
Blood samples
Measured: 5 years postoperative
Number of patients with mineral deficiencies
Blood samples
Measured: 5 years postoperative
Number of patients with vitamin deficiencies
Blood samples
Measured: 5 years postoperative
Adverse events
Medical history, journals
Measured: 5 years
Weight loss 10 years
Weight measure
Measured: 10 years postoperative
Adverse events
Medical history, journals
Measured: 10 years postoperative
Number of patients with malnutrition
Blood samples
Measured: 10 years postoperative
Number of patients with mineral deficiencies
Blood samples
Measured: 10 years postoperative
Number of patients with vitamin deficiencies
Blood samples
Measured: 10 years postoperative
Health related Quality of life
questionnaire
Measured: 10 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startFeb 2011
- Primary completionMay 2015
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Oslo University 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital of Vestfold
- Responsible party
- Principal investigator, Tom Mala, Oslo University Hospital
- Investigators
- Tom Mala MD, PhD Rune Sandbu, MD, PhD, Study chair, Aker University Hospital / The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821197
- Sponsor's protocol ID
- AT-0910-ST
- Status last verified
- Sep 2021
- First submitted
- 12 Jan 2009
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Salte OB, Hagen RE, Svanevik M, Fagerland MW, Risstad H, Hjelmesaeth J, Kristinsson JA, Sandbu R, Mala T. Effect of standard versus long alimentary limb distal Roux-en-Y gastric bypass on weight loss and nutritional outcomes at 10 years in patients with BMI 50-60 kg/m2-a secondary analysis of a randomized clinical trial. Br J Surg. 2025 Dec 24;113(1):znaf285. doi: 10.1093/bjs/znaf285.
PubMed 41553109Salte OBK, Svanevik M, Risstad H, Hofso D, Blom-Hogestol IK, Johnson LK, Fagerland MW, Kristinsson J, Hjelmesaeth J, Mala T, Sandbu R. Standard versus distal Roux-en-Y gastric bypass in patients with BMI 50-60 kg/m2: 5-year outcomes of a double-blind, randomized clinical trial. BJS Open. 2021 Nov 9;5(6):zrab105. doi: 10.1093/bjsopen/zrab105.
PubMed 34791048Svanevik M, Risstad H, Hofso D, Blom-Hogestol IK, Kristinsson JA, Sandbu R, Smastuen MC, Thorsby PM, Mala T, Hjelmesaeth J. Bone Turnover Markers After Standard and Distal Roux-en-Y Gastric Bypass: Results from a Randomized Controlled Trial. Obes Surg. 2019 Sep;29(9):2886-2895. doi: 10.1007/s11695-019-03909-1.
PubMed 31065919Svanevik M, Risstad H, Karlsen TI, Kristinsson JA, Smastuen MC, Kolotkin RL, Sovik TT, Sandbu R, Mala T, Hjelmesaeth J. Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial. Obes Surg. 2018 Mar;28(3):606-614. doi: 10.1007/s11695-017-2891-3.
PubMed 28865057Risstad H, Svanevik M, Kristinsson JA, Hjelmesaeth J, Aasheim ET, Hofso D, Sovik TT, Karlsen TI, Fagerland MW, Sandbu R, Mala T. Standard vs Distal Roux-en-Y Gastric Bypass in Patients With Body Mass Index 50 to 60: A Double-blind, Randomized Clinical Trial. JAMA Surg. 2016 Dec 1;151(12):1146-1155. doi: 10.1001/jamasurg.2016.2798.
PubMed 27626242Svanevik M, Risstad H, Hofso D, Schou CF, Solheim B, Sovik TT, Kristinsson J, Hjelmesaeth J, Mala T, Sandbu R. Perioperative Outcomes of Proximal and Distal Gastric Bypass in Patients with BMI Ranged 50-60 kg/m(2)--A Double-Blind, Randomized Controlled Trial. Obes Surg. 2015 Oct;25(10):1788-95. doi: 10.1007/s11695-015-1621-y.
PubMed 25761943
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long -Limb Gastric or Distal Gastric Bypass in the Treatment of Super Obese Patients - a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00821197
- Acronym / sponsor ID
- AT-0910-ST
- Conditions
- Obesity
- Keywords
- obesity, laparoscopy, bariatric, super obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Hospital of Vestfold
- Study start
- Feb 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 13 Jan 2009 (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.
The main study objective:
To evaluate long-limb gastric bypass (150 cm alimentary limb) vs. "distal" gastric bypass (common channel 150 cm) in the treatment of superobesity (BMI 50-60 kg/m2).
The main study hypothesis:
Distal bypass accomplish an estimated 10-20 % larger weightloss than long-limb gastric bypass 1 year after surgery. Patients subject to distal bypass have more gastrointestinal side effects and more extensive nutritional deficiences compared to long-limb gastric bypass.
Detailed description
Technical data will later be published in detail
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long-limb bypass | Active comparator | Procedure: long-limb gastric bypassLaparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb) |
| Distal gastric bypass | Active comparator | Procedure: distal gastric bypassLaparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 50 - 60 kg/m2 at admission for evaluation for bariatric surgery
- BMI 48 - 62 kg/m2 at study inclusion
- informed consent
- scheduled for bariatric surgery
Key exclusion criteria (5 listed)
- previous bariatric surgery
- previous major abdominal surgery
- previous history or established urolithiasis
- viral hepatitis, liver cirrhosis of any kind
- factors making the patient not eligible to understand and commit to the study protocol (severe psychiatric disease or drug/narcotic abuse)
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 |
|---|---|---|
| long-limb gastric bypassLaparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb) | Procedure or surgery | long-limb bypass |
| distal gastric bypassLaparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb) | Procedure or surgery | Distal gastric bypass |
Primary outcome
Primary outcome: weight loss
Time frame: 2 years postoperatively
physical examination
17 secondary outcomes
Secondary outcome: Quality of life
Time frame: 2 years postoperative
Adverse events
Time frame: 2 years postoperative
Number of patients with vitamin deficiencies
Time frame: 2 years postoperative
Number of patients with mineral deficiencies
Time frame: 2 years postoperative
Number of participants with malnutrition
Time frame: 2 years postoperative
Weight loss 5 year
Time frame: 5 year postoperative
Health related Quality of life
Time frame: 5 years postoperative
Number of patients with malnutrition
Time frame: 5 years postoperative
Number of patients with mineral deficiencies
Time frame: 5 years postoperative
Number of patients with vitamin deficiencies
Time frame: 5 years postoperative
Adverse events
Time frame: 5 years
Weight loss 10 years
Time frame: 10 years postoperative
Adverse events
Time frame: 10 years postoperative
Number of patients with malnutrition
Time frame: 10 years postoperative
Number of patients with mineral deficiencies
Time frame: 10 years postoperative
Number of patients with vitamin deficiencies
Time frame: 10 years postoperative
Health related Quality of life
Time frame: 10 years postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Derived from this study: PubMed 41553109Salte OB, Hagen RE, Svanevik M, Fagerland MW, Risstad H, Hjelmesaeth J, Kristinsson JA, Sandbu R, Mala T. Effect of standard versus long alimentary limb distal Roux-en-Y gastric bypass on weight loss and nutritional outcomes at 10 years in patients with BMI 50-60 kg/m2-a secondary analysis of a randomized clinical trial. Br J Surg. 2025 Dec 24;113(1):znaf285. doi: 10.1093/bjs/znaf285.
- Derived from this study: PubMed 34791048Salte OBK, Svanevik M, Risstad H, Hofso D, Blom-Hogestol IK, Johnson LK, Fagerland MW, Kristinsson J, Hjelmesaeth J, Mala T, Sandbu R. Standard versus distal Roux-en-Y gastric bypass in patients with BMI 50-60 kg/m2: 5-year outcomes of a double-blind, randomized clinical trial. BJS Open. 2021 Nov 9;5(6):zrab105. doi: 10.1093/bjsopen/zrab105.
- Derived from this study: PubMed 31065919Svanevik M, Risstad H, Hofso D, Blom-Hogestol IK, Kristinsson JA, Sandbu R, Smastuen MC, Thorsby PM, Mala T, Hjelmesaeth J. Bone Turnover Markers After Standard and Distal Roux-en-Y Gastric Bypass: Results from a Randomized Controlled Trial. Obes Surg. 2019 Sep;29(9):2886-2895. doi: 10.1007/s11695-019-03909-1.
- Derived from this study: PubMed 28865057Svanevik M, Risstad H, Karlsen TI, Kristinsson JA, Smastuen MC, Kolotkin RL, Sovik TT, Sandbu R, Mala T, Hjelmesaeth J. Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial. Obes Surg. 2018 Mar;28(3):606-614. doi: 10.1007/s11695-017-2891-3.
- Derived from this study: PubMed 27626242Risstad H, Svanevik M, Kristinsson JA, Hjelmesaeth J, Aasheim ET, Hofso D, Sovik TT, Karlsen TI, Fagerland MW, Sandbu R, Mala T. Standard vs Distal Roux-en-Y Gastric Bypass in Patients With Body Mass Index 50 to 60: A Double-blind, Randomized Clinical Trial. JAMA Surg. 2016 Dec 1;151(12):1146-1155. doi: 10.1001/jamasurg.2016.2798.
- Derived from this study: PubMed 25761943Svanevik M, Risstad H, Hofso D, Schou CF, Solheim B, Sovik TT, Kristinsson J, Hjelmesaeth J, Mala T, Sandbu R. Perioperative Outcomes of Proximal and Distal Gastric Bypass in Patients with BMI Ranged 50-60 kg/m(2)--A Double-Blind, Randomized Controlled Trial. Obes Surg. 2015 Oct;25(10):1788-95. doi: 10.1007/s11695-015-1621-y.
- hospital siteLink provided by the sponsor.
- hospital siteLink provided by the sponsor.
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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.
Tom Mala MD, PhD Rune Sandbu, MD, PhD study chair
Aker University Hospital / The Hospital of Vestfold
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing long-limb gastric bypass and distal gastric bypass in people with Obesity, run by Oslo University Hospital at 1 site in Norway.
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 4 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Results are not available in the source record.
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?
Primary outcome: weight loss (time frame: 2 years postoperatively). 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 NCT00821197, which also lists 6 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 5 Sep 2021.