Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001497392
Ethics application status
Approved
Date submitted
28/08/2017
Date registered
24/10/2017
Date last updated
24/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of a quality improvement program for the management of patients undergoing bowel resection
Scientific title
Assessment of a quality improvement program´s effect on the anastomotic leakage rate for patients undergoing colorectal resections.
Secondary ID [1] 292752 0
None
Universal Trial Number (UTN)
U1111-1201-3525
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anastomotic leakage 304535 0
Condition category
Condition code
Surgery 303859 303859 0 0
Other surgery
Oral and Gastrointestinal 304239 304239 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A quality improvement program for all patients undergoing colorectal resections at the Karolinska University Hospital (Section of coloproctology). The program contains three key elements and was implemented in January 2010. The post implementation study period was January 2010-December 2013.
1. Exclusion of nonsteroidal anti-inflammatory drugs peri-operatively from 5 days before surgery to 7 days after surgery..
2. Introduction of intra-operative goal-directed fluid therapy. This was managed by stroke volume optimization using esphageal Doppler (CardioQ-ODM, Deltex Medical, Chichester, UK).
3. Avoidance of primary anastomoses in emergency resections. Surgeons were instructed to avoid emergency oncological resections of obstructing cancers by instead performing temporary defunctioning ostomies or avoid primary anastomosis if emergency resection was unavoidable (i.e. bowel perforation or severe bleeding).
Intervention code [1] 298988 0
Not applicable
Comparator / control treatment
The control group is the cohort of patients that were operated with colorectal resections at the Karolinska University Hospital (Section of coloproctology) during the last four years before the implementation of the quality improvement program i.e. January 2006-December 2009.
Control group
Historical

Outcomes
Primary outcome [1] 303218 0
Primary endpoint is the proportion of patients developing anastomotic leakage after colorectal resections with primary anastomosis.
Timepoint [1] 303218 0
Primary endpoint is anastomotic leakage detected at re-operation or by CT-scan with rectal contrast within 30 days post operatively. Data are recorded prospectively by a research nurse and put in to a local quality data base..
Secondary outcome [1] 338263 0
Postoperative length of stay in hospital (days).
Timepoint [1] 338263 0
At hospital discharge

Eligibility
Key inclusion criteria
Consecutive patients operated with colorectal resections with primary anastomosis at the Section of coloproctology at the Karolinska University Hospital during four years up to the implementation of a quality improvement program, and during four years after the implementation.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No patients are excluded if they meet the inclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Power calculation shows that with a power of 80% for the detection of a decrease in anastomotic leakage rate from 10% to 5% the number of participants in each group must be at least 435. The study period is set accordingly. The assumption is based on data from our local quality data base and other similar studies.
Groups are compared with non-parametric tests and Fisher’s exact tests. Univariable logistic regression is used to assess the crude effect of study period and other predictors on anastomotic leakage. Potential confounders are assessed with multivariable logistic regression analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/02/2014
Date of last participant enrolment
Anticipated
Actual
24/04/2015
Date of last data collection
Anticipated
Actual
24/04/2015
Sample size
Target
870
Accrual to date
Final
894
Recruitment outside Australia
Country [1] 9171 0
Sweden
State/province [1] 9171 0
Stockholm

Funding & Sponsors
Funding source category [1] 297387 0
Hospital
Name [1] 297387 0
Karolinska University Hospital
Country [1] 297387 0
Sweden
Primary sponsor type
Individual
Name
Henrik Iversen
Address
Department of Molecular Medicine and Surgery, Karolinska Institutet and Center for Digestive Diseases, Karolinska University Hospital, Solna, P9:03, 17176, Stockholm, Sweden
Country
Sweden
Secondary sponsor category [1] 296371 0
Hospital
Name [1] 296371 0
Karolinska University Hospital
Address [1] 296371 0
Department of Molecular Medicine and Surgery, Karolinska Institutet and Center for Digestive Diseases, Karolinska University Hospital, Solna, P9:03, 17176, Stockholm, Sweden
Country [1] 296371 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298487 0
Local ethics committee in Stockholm (Regionala etikprövningsnämnden i Stockholm)
Ethics committee address [1] 298487 0
Regionala etikprövningsnämnden i Stockholm
Karolinska Institutet
Widerströmska huset
Tomtebodavägen 18A,
171 65 Solna
Sweden
Ethics committee country [1] 298487 0
Sweden
Date submitted for ethics approval [1] 298487 0
Approval date [1] 298487 0
05/10/2016
Ethics approval number [1] 298487 0
reference number 2016/1764-31).

Summary
Brief summary
Failure of healing bowel joints after surgery constitutes a serious clinical problem. The purpose of this study is to assess if a quality improvement program at the Karolinska University Hospital can reduce the risk for complications after bowel surgery. The hypothesis is that structured changes in clinical practice can reduce the risk of leakage in surgically constructed bowel joints. The different components that constitutes the program have been suggested to improve surgical outcomes in previous studies. The outcomes for patients operated before and after the implementation of the quality improvement program will be compared.
Trial website
Trial related presentations / publications
None
Public notes
The study was initiated before the ethics approval date. This is due to the fact that the trial is retrospective and observational and based on data from a local prospective quality registry. This type of audit and assessment does normally not require an ethics approval in Sweden but was applied for when publication of the results was intended.

Contacts
Principal investigator
Name 77242 0
Dr Henrik Iversen
Address 77242 0
Department of Molecular Medicine and Surgery, Karolinska Institutet and Center for Digestive Diseases, Karolinska University Hospital, Solna, P9:03, 17176, Stockholm
Country 77242 0
Sweden
Phone 77242 0
+46 8 51772846
Fax 77242 0
Email 77242 0
[email protected]
Contact person for public queries
Name 77243 0
Dr Henrik Iversen
Address 77243 0
Department of Molecular Medicine and Surgery, Karolinska Institutet and Center for Digestive Diseases, Karolinska University Hospital, Solna, P9:03, 17176, Stockholm
Country 77243 0
Sweden
Phone 77243 0
+46 704381594
Fax 77243 0
Email 77243 0
[email protected]
Contact person for scientific queries
Name 77244 0
Dr Henrik Iversen
Address 77244 0
Department of Molecular Medicine and Surgery, Karolinska Institutet and Center for Digestive Diseases, Karolinska University Hospital, Solna, P9:03, 17176, Stockholm
Country 77244 0
Sweden
Phone 77244 0
+46 8 51772846
Fax 77244 0
Email 77244 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseChanges in Clinical Practice Reduce the Rate of Anastomotic Leakage After Colorectal Resections.2018https://dx.doi.org/10.1007/s00268-017-4423-7
N.B. These documents automatically identified may not have been verified by the study sponsor.