Surgical AdhesionsNCT03663023
Band Adhesions in Relation to Previous Abdominal Surgery
An observational study of Surgical Adhesions and Intestinal Obstruction, run by Göteborg University.
Trial summary
This study investigates the prevalence of previous abdominal surgery in a cohort of patients operated for bowel obstruction and analyzes the causes of obstruction discovered at surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Adhesions, Intestinal Obstruction, Surgery Induced Tissue Adhesions
- What is being tested?
- Intestinal obstruction
- Type of treatment
- Surgery or procedure
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Oct 2011
- 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: According to the protocol, 213 surgical procedures were identified. 17 procedures were excluded due to no bowel obstruction at surgery. Intestinal obstruction was evident in 196 procedures. These procedures were included in this study.
Who may be able to join
- Subjects operated for bowel obstruction -from January 1st 2006 to October 31st 2011
- Surgical codes for bowel obstruction:
- Intestinal adhesion with obstruction
- Other and unspecified intestinal obstruction
- Intestinal obstruction
- Unspecified and Peritoneal adhesions
Show all 11Show fewer
- Surgical procedures identified for bowel obstruction:
- Division of band adhesion
- Adhesiolysis
- Other separation of adhesion during bowel obstruction
- Laparotomy and reposition or detorsion of intestine.
Who cannot join
- -Extra-peritoneal surgery such as inguinal or ventral hernia repair was excluded.
About this study
Official title: Band Adhesions in Relation to Previous Abdominal Surgery - a Retrospective Analysis of Risk Factors
This study investigates the prevalence of previous abdominal surgery in a cohort of patients operated for bowel obstruction and analyzes the causes of obstruction discovered at surgery.
Read the detailed description
Postoperative intra-abdominal adhesions are a common cause of small bowel obstruction. The extent of adhesions has been assigned to the magnitude of previous surgery. In a county hospital, with a catchment population of 120 000 inhabitants, records of operations performed for bowel obstruction over a period of 70 months were retrieved. Codes for bowel obstruction according to an International Classification of Diseases (ICD-10) will include: Intestinal adhesion with obstruction, Other and unspecified intestinal obstruction, Intestinal obstruction and Peritoneal adhesions. Amount of adhesions will be calculated in relation to previous surgery.
- Being tested
- Intestinal obstruction
- Medical subject headings
- Tissue Adhesions, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal obstructionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Cause of bowel obstruction
Bowel obstruction; caused by adhesions, malignant disease, inflammation or other causes
Measured: 70 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Jan 2006
- Primary completion31 Oct 2011
- Study completion31 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical AdhesionsStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663023
- Sponsor's protocol ID
- Adhesions2018vgr
- Status last verified
- Feb 2023
- First submitted
- 6 Sep 2018
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Band Adhesions in Relation to Previous Abdominal Surgery - a Retrospective Analysis of Risk Factors
- ClinicalTrials.gov ID
- NCT03663023
- Acronym / sponsor ID
- Adhesions2018vgr
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Oct 2011 (actual)
- Study completion
- 31 Oct 2011 (actual)
- First posted
- 10 Sep 2018 (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.
This study investigates the prevalence of previous abdominal surgery in a cohort of patients operated for bowel obstruction and analyzes the causes of obstruction discovered at surgery.
Detailed description
Postoperative intra-abdominal adhesions are a common cause of small bowel obstruction. The extent of adhesions has been assigned to the magnitude of previous surgery. In a county hospital, with a catchment population of 120 000 inhabitants, records of operations performed for bowel obstruction over a period of 70 months were retrieved. Codes for bowel obstruction according to an International Classification of Diseases (ICD-10) will include: Intestinal adhesion with obstruction, Other and unspecified intestinal obstruction, Intestinal obstruction and Peritoneal adhesions. Amount of adhesions will be calculated in relation to previous surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- According to the protocol, 213 surgical procedures were identified. 17 procedures were excluded due to no bowel obstruction at surgery. Intestinal obstruction was evident in 196 procedures. These procedures were included in this study.
Key inclusion criteria (11 listed)
- Subjects operated for bowel obstruction -from January 1st 2006 to October 31st 2011
- Intestinal adhesion with obstruction
- Other and unspecified intestinal obstruction
- Intestinal obstruction
- Unspecified and Peritoneal adhesions
Key exclusion criteria (1 listed)
- -Extra-peritoneal surgery such as inguinal or ventral hernia repair was excluded.
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 |
|---|---|---|
| Intestinal obstruction | Procedure or surgery | – |
Primary outcome
Cause of bowel obstruction
Time frame: 70 months
Bowel obstruction; caused by adhesions, malignant disease, inflammation or other causes
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 24 Feb 2023.
- 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.
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 Surgical Adhesions and Intestinal Obstruction, run by Göteborg University.
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 11 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 24 Feb 2023. 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?
Cause of bowel obstruction (time frame: 70 months). 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 24 Feb 2023.