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Band Adhesions in Relation to Previous Abdominal Surgery - a Retrospective Analysis of Risk Factors

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ClinicalTrials.gov Identifier: NCT03663023
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Tracking Information
First Submitted Date September 6, 2018
First Posted Date September 10, 2018
Last Update Posted Date September 10, 2018
Actual Study Start Date January 1, 2006
Actual Primary Completion Date October 31, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2018)
Cause of bowel obstruction [ Time Frame: 70 months ]
Bowel obstruction; caused by adhesions, malignant disease, inflammation or other causes
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Band Adhesions in Relation to Previous Abdominal Surgery - a Retrospective Analysis of Risk Factors
Official Title Band Adhesions in Relation to Previous Abdominal Surgery - a Retrospective Analysis
Brief 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition
  • Surgical Adhesions
  • Intestinal Obstruction
  • Surgery Induced Tissue Adhesions
Intervention Procedure: Intestinal obstruction
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 6, 2018)
196
Original Actual Enrollment Same as current
Actual Study Completion Date October 31, 2011
Actual Primary Completion Date October 31, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

All subjects operated for bowel obstruction from January 1st 2006 to October 31st 2011. Surgical codes for bowel obstruction included: Intestinal adhesion with obstruction, Other and unspecified intestinal obstruction, Intestinal obstruction, unspecified and Peritoneal adhesions. Surgical procedures were identified for bowel obstruction, including; Division of band adhesion, Adhesiolysis, Other separation of adhesion during bowel obstruction, Laparotomy and reposition or detorsion of intestine.

Exclusion Criteria:

Extra-peritoneal surgery such as inguinal or ventral hernia repair was excluded.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03663023
Other Study ID Numbers Adhesions2018vgr
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Göteborg University
Study Sponsor Göteborg University
Collaborators Not Provided
Investigators Not Provided
PRS Account Göteborg University
Verification Date September 2018