Postoperative ComplicationsNCT01862159
Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery
An observational study of Postoperative Complications, run by Region Örebro County at 1 site in Sweden.
Trial summary
The rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. There are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- laparoscopic gastric bypass surgery
- Type of treatment
- Surgery or procedure
- How many people
- 25,038 participants
- Where
- 1 siteSweden
- Study dates
- May 2007to May 2013
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing bariatric surgery in Sweden
Who may be able to join
- Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry
Who cannot join
- Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded.
- Lost to follow up.
Trial locations and contacts
1 site in 1 country.
About this study
The rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. There are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. If the investigators are aware of these we can optimize the patients risk factors prior to the operation or at least increase the awareness of the increased risk in some patients given the presence of risk factors.
Read the detailed description
Data is collected prospectively to the Scandinavian Obesity Surgery Registry. Today all 44 clinics performing bariatric surgery in Sweden submits data on baseline characteristics, operational data and data from a 30 days, 1 year, 2 years and 5 years follow up for all patients. The database is compared annually to the Swedish civil registry to cover all mortality.
From the database we will identify patients who underwent a bariatric procedure between May 1st 2007 and September 30th 2012. Patients undergoing other bariatric procedures than laparoscopic gastric bypass or revisional surgery will be excluded.
The data will be analyzed with "Chi-2" test, logarithmic regression, linear regression or t-test when appropriate. Odds ratio will be calculated.
- Conditions
- Postoperative Complications
- Being tested
- laparoscopic gastric bypass surgery
- Keywords
- bariatric surgery, postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic gastric bypass surgeryProcedure or surgery
laparoscopic gastric bypass surgery
| Study group | Role | What they receive |
|---|---|---|
| Operated patients | Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 Receives: Procedure: laparoscopic gastric bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Complications
Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)
Measured: 30 days or the postoperative hospital stay if longer than 30 days
Secondary outcomes (3)
Operating Time
length of the operation
Measured: operation
Length of Stay
Length of stay after the primary operation
Measured: 30 days or the postoperative hospital stay if longer than 30 days
Specific Postoperative Complications
Any complication (Anastomotic leakage/abscesses, bleeding, small bowel obstruction, stomal ulcera, cardiovascular complications, pulmonary complications, venous thromboembolism, port site complication, other complication)
Measured: 30 days or the postoperative hospital stay if longer than 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startMay 2007
- Primary completionNov 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,038 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Scandinavian Obesity Surgery Registry
- Responsible party
- Principal investigator, Erik Stenberg, MD, Region Örebro County
- Investigators
- Ingmar Näslund, MD, PhD, Study chair, The Scandinavian Obesity Surgery RegistryErik Stenberg, MD, Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862159
- Sponsor's protocol ID
- EPN 2012/039
- Status last verified
- Apr 2017
- First submitted
- 2 May 2013
- Last updated
- 11 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT01862159
- Acronym / sponsor ID
- EPN 2012/039
- Conditions
- Postoperative Complications
- Keywords
- bariatric surgery, postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,038 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Scandinavian Obesity Surgery Registry
- Study start
- May 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Posted 11 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. There are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. If the investigators are aware of these we can optimize the patients risk factors prior to the operation or at least increase the awareness of the increased risk in some patients given the presence of risk factors.
Detailed description
Data is collected prospectively to the Scandinavian Obesity Surgery Registry. Today all 44 clinics performing bariatric surgery in Sweden submits data on baseline characteristics, operational data and data from a 30 days, 1 year, 2 years and 5 years follow up for all patients. The database is compared annually to the Swedish civil registry to cover all mortality.
From the database we will identify patients who underwent a bariatric procedure between May 1st 2007 and September 30th 2012. Patients undergoing other bariatric procedures than laparoscopic gastric bypass or revisional surgery will be excluded.
The data will be analyzed with "Chi-2" test, logarithmic regression, linear regression or t-test when appropriate. Odds ratio will be calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operated patients | – | Procedure: laparoscopic gastric bypass surgeryPatients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing bariatric surgery in Sweden
Key inclusion criteria (1 listed)
- Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry
Key exclusion criteria (2 listed)
- Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded.
- Lost to follow up.
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 |
|---|---|---|
| laparoscopic gastric bypass surgerylaparoscopic gastric bypass surgery | Procedure or surgery | Operated patients |
Primary outcome
Serious Complications
Time frame: 30 days or the postoperative hospital stay if longer than 30 days
Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)
3 secondary outcomes
Operating Time
Time frame: operation
Length of Stay
Time frame: 30 days or the postoperative hospital stay if longer than 30 days
Specific Postoperative Complications
Time frame: 30 days or the postoperative hospital stay if longer than 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The Scandinavian Obesity Surgery RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ingmar Näslund, MD, PhD study chair
The Scandinavian Obesity Surgery Registry
Erik Stenberg, MD principal investigator
Region Örebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Region Örebro County at 1 site in Sweden.
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 2 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 11 Aug 2017. 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serious Complications (time frame: 30 days or the postoperative hospital stay if longer than 30 days). 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 11 Aug 2017.