Obesity, MorbidNCT02763501
Comparing a Randomised Controlled Intervention With Observational Data.
A study testing closure of mesenteric defects and non-closure of mesenteric defects in people with Obesity, Morbid, run by Region Örebro County.
Trial summary
Comparison of participants in a randomised controlled trial (RCT) with observational data from patients operated in Sweden during the same period of time. The primary objective is to compare effects from a complex surgical intervention from RCT and observational data. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- closure of mesenteric defects and non-closure of mesenteric defects
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,992 participants
- Where
- No sites listed yet
- Study dates
- May 2010to May 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The same as acceptance criteria for bariatric surgery according to the 1991 NIH Consensus Statement
Who cannot join
- retrocolic gastric bypass procedure
- previous bariatric procedures
- primary open procedures
- missing data on handling of the mesenteric defects
About this study
Comparison of participants in a randomised controlled trial (RCT) with observational data from patients operated in Sweden during the same period of time. The primary objective is to compare effects from a complex surgical intervention from RCT and observational data.
Read the detailed description
Randomised controlled trials (RCT) are "golden standard" for assessing interventions in medical science. Due to ethical or practical reasons, RCTs may however not always be feasible. The study objective was to test if the results from the RCT differ from observational data in a setting with a complex surgical intervention.
Using the Scandinavian Obesity Surgery Registry database we intend to compare patients operated with laparoscopic gastric bypass surgery within a register based RCT from May 1st 2010 until Nov 14th 2011, with all patients operated with the same procedure registered in the database during the same period of time.
Primary end-point measures are severe complications within 30 days (safety outcome) and surgery for small bowel obstruction (efficacy outcome) within 4 years.
- Conditions
- Obesity, Morbid
- Being tested
- closure of mesenteric defects, non-closure of mesenteric defects
- Keywords
- bariatric surgery, gastric bypass, intestinal obstruction, postoperative complication, methods, laparoscopy
- Medical subject headings
- Obesity, Morbid, Intestinal Obstruction, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closure of mesenteric defectsProcedure or surgery
Closure of mesenteric defects by use of non-absorbable running sutures in RCT; and according to the choice of the surgeon in the non-RCT
non-closure of mesenteric defectsProcedure or surgery
Mesenteric defects are left open
| Study group | Role | What they receive |
|---|---|---|
| RCT | Active comparator | patients operated with laparoscopic gastric bypass surgery within a register based RCT from May 1st 2010 until Nov 14th 2011.
1:1 randomization to closure of mesenteric defects by running, non-absorbable sutures Receives: Procedure: closure of mesenteric defects; Procedure: non-closure of mesenteric defects |
| non-RCT | Active comparator | patients operated with laparoscopic gastric bypass surgery outside of the RCT from May 1st 2010 until Nov 14th 2011.
Intervention of mesenteric defects according to local tradition or choice of surgeon (non-randomized) Receives: Procedure: closure of mesenteric defects; Procedure: non-closure of mesenteric defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
severe postoperative complications within 30 days
Specified as Clavien-Dindo grade 3b or more
Measured: 30 days
reoperation for small bowel obstruction
Efficacy outcome: Number of participants with reoperation due to small bowel obstruction defined as acute symptoms of bowel obstruction with findings suggestive of small bowel obstruction during surgery
Measured: 4 years
Secondary outcomes (4)
postoperative length of stay
Measured: 30 days
length of the operation
Measured: intraoperative
specific postoperative complications
leakage or deep intra-abdominal infection, bleeding requiring intervention, small bowel obstruction/ileus, port-related complications, wound dehiscence, other wound complications (mainly superficial wound infections), anastomotic stricture, marginal ulcer, cardiovascular length of the operation event, pulmonary complication (other than pulmonary embolism), venous thromboembolism (including pulmonary embolism), urinary tract infection and other (in this case specified) complication
Measured: 30 days
weight-loss at 2 years after surgery
specified as excessive weight-loss (% excess weight loss = 100 x [initial weight-postoperative weight]/[initial weight-weight corresponding to BMI 25 kg/m2])
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2010
- Primary completionDec 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- 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
- 10,992 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- The Scandinavian Obesity Surgery Registry
- Responsible party
- Principal investigator, Erik Stenberg, MD, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763501
- Sponsor's protocol ID
- EPN 2015/097
- Status last verified
- Oct 2016
- First submitted
- 3 May 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Group data will be published. Deidentified individual participant data for all primary and secondary outcomes will be available after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Randomised Controlled Intervention With Observational Data.
- ClinicalTrials.gov ID
- NCT02763501
- Acronym / sponsor ID
- EPN 2015/097
- Conditions
- Obesity, Morbid
- Keywords
- bariatric surgery, gastric bypass, intestinal obstruction, postoperative complication, methods, laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,992 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- The Scandinavian Obesity Surgery Registry
- Study start
- May 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 May 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.
Comparison of participants in a randomised controlled trial (RCT) with observational data from patients operated in Sweden during the same period of time. The primary objective is to compare effects from a complex surgical intervention from RCT and observational data.
Detailed description
Randomised controlled trials (RCT) are "golden standard" for assessing interventions in medical science. Due to ethical or practical reasons, RCTs may however not always be feasible. The study objective was to test if the results from the RCT differ from observational data in a setting with a complex surgical intervention.
Using the Scandinavian Obesity Surgery Registry database we intend to compare patients operated with laparoscopic gastric bypass surgery within a register based RCT from May 1st 2010 until Nov 14th 2011, with all patients operated with the same procedure registered in the database during the same period of time.
Primary end-point measures are severe complications within 30 days (safety outcome) and surgery for small bowel obstruction (efficacy outcome) within 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RCT | Active comparator | Procedure: closure of mesenteric defects, Procedure: non-closure of mesenteric defectspatients operated with laparoscopic gastric bypass surgery within a register based RCT from May 1st 2010 until Nov 14th 2011. 1:1 randomization to closure of mesenteric defects by running, non-absorbable sutures |
| non-RCT | Active comparator | Procedure: closure of mesenteric defects, Procedure: non-closure of mesenteric defectspatients operated with laparoscopic gastric bypass surgery outside of the RCT from May 1st 2010 until Nov 14th 2011. Intervention of mesenteric defects according to local tradition or choice of surgeon (non-randomized) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The same as acceptance criteria for bariatric surgery according to the 1991 NIH Consensus Statement
Key exclusion criteria (4 listed)
- retrocolic gastric bypass procedure
- previous bariatric procedures
- primary open procedures
- missing data on handling of the mesenteric defects
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 |
|---|---|---|
| closure of mesenteric defectsClosure of mesenteric defects by use of non-absorbable running sutures in RCT; and according to the choice of the surgeon in the non-RCT | Procedure or surgery | RCT, non-RCT |
| non-closure of mesenteric defectsMesenteric defects are left open | Procedure or surgery | RCT, non-RCT |
Primary outcome
severe postoperative complications within 30 days
Time frame: 30 days
Specified as Clavien-Dindo grade 3b or more
reoperation for small bowel obstruction
Time frame: 4 years
Efficacy outcome: Number of participants with reoperation due to small bowel obstruction defined as acute symptoms of bowel obstruction with findings suggestive of small bowel obstruction during surgery
4 secondary outcomes
postoperative length of stay
Time frame: 30 days
length of the operation
Time frame: intraoperative
specific postoperative complications
Time frame: 30 days
weight-loss at 2 years after surgery
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- The Scandinavian Obesity Surgery RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: No. Group data will be published. Deidentified individual participant data for all primary and secondary outcomes will be available after study completion.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing closure of mesenteric defects and non-closure of mesenteric defects in people with Obesity, Morbid, run by Region Örebro County.
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 4 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: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
severe postoperative complications within 30 days (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2016.