SurgeryNCT05516420
Predicting Abdominal Reoperation
An observational study of Surgery and Abdominal Adhesion, run by Radboud University Medical Center.
Trial summary
Nationwide retrospective study, to predict the risk of abdominal reoperation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Abdominal Adhesion
- How many people
- 72,270 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2009to 1 Aug 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing first abdominal or pelvic surgery between June 1st 2009 and June 30th 2011 in Scotland.
Who may be able to join
- All patients undergoing first abdominal or pelvic surgery between June 1st 2009 and June 30th 2011 in Scotland.
Who cannot join
- Positive history for abdominal surgery
About this study
Official title: Predicting Long-term Risk of Reoperations Following Abdominal and Pelvic Surgery: a Nationwide Retrospective Cohort Study
Nationwide retrospective study, to predict the risk of abdominal reoperation.
- Conditions
- Surgery, Abdominal Adhesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with first abdominal surgery in Scotland between 2009 and 2011 | Patients with first abdominal surgery in Scotland between 2009 and 2011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with an abdominal reoperation in the study cohort
Number of patients undergoing a reoperation after abdominal surgery
Measured: within 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Jun 2009
- Primary completion1 Dec 2018
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Retrospective
- Enrolment
- 72,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Research Scotland
- Responsible party
- Principal investigator, Richard ten Broek, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516420
- Sponsor's protocol ID
- SCARreop
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the Scottish National Health Service (NHS). Restrictions apply to the availability of these data, which were used under license for this study. Data derived from the analysis are available from the authors with the permission of the Scottish NHS. The used repository was the Safe Haven (https://shs.epcc.ed.ac.uk/2fa/scotnsh.html) from the NHS.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Long-term Risk of Reoperations Following Abdominal and Pelvic Surgery: a Nationwide Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05516420
- Acronym / sponsor ID
- SCARreop
- Conditions
- Surgery, Abdominal Adhesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72,270 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- NHS Research Scotland
- Study start
- 1 Jun 2009 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 25 Aug 2022 (actual)
- 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.
Nationwide retrospective study, to predict the risk of abdominal reoperation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with first abdominal surgery in Scotland between 2009 and 2011 | – | –Patients with first abdominal surgery in Scotland between 2009 and 2011 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing first abdominal or pelvic surgery between June 1st 2009 and June 30th 2011 in Scotland.
Key inclusion criteria (1 listed)
- All patients undergoing first abdominal or pelvic surgery between June 1st 2009 and June 30th 2011 in Scotland.
Key exclusion criteria (1 listed)
- Positive history for abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with an abdominal reoperation in the study cohort
Time frame: within 5 years postoperatively
Number of patients undergoing a reoperation after abdominal surgery
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 25 Aug 2022.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the Scottish National Health Service (NHS). Restrictions apply to the availability of these data, which were used under license for this study. Data derived from the analysis are available from the authors with the permission of the Scottish NHS. The used repository was the Safe Haven (https://shs.epcc.ed.ac.uk/2fa/scotnsh.html) from the NHS.
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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?
An observational study of Surgery and Abdominal Adhesion, run by Radboud University Medical Center.
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 1 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 25 Aug 2022. 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?
Number of patients with an abdominal reoperation in the study cohort (time frame: within 5 years postoperatively). 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 25 Aug 2022.