Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000096156
Ethics application status
Approved
Date submitted
17/01/2019
Date registered
23/01/2019
Date last updated
23/01/2019
Date data sharing statement initially provided
23/01/2019
Date results information initially provided
23/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rectal stump management after subtotal colectomy for severe colitis
Scientific title
Rectal stump management after subtotal colectomy for severe colitis patients: Does in-situ or extra-fascial placement affect complications?
Secondary ID [1] 297125 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis 311144 0
Rectal stump management 311145 0
Condition category
Condition code
Surgery 309773 309773 0 0
Surgical techniques
Oral and Gastrointestinal 309787 309787 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients were either operated with the rectal stump left in-situ or extra-fascially. Our study then measured 30 day postoperative outcomes (pelvic and systemic sepsis, wound infection, overall complications) and mortality rates after different rectal stump management techniques in subtotal colectomy for severe colitis.

Intervention code [1] 313389 0
Not applicable
Comparator / control treatment
In-situ placement of the rectal stump during the operation (comparator)
Extra-fascial placement of the rectal stump during the operation (comparator)
Study had no control group. The duration of the study was between 1993 until 2018, retrospective data collection
Control group
Active

Outcomes
Primary outcome [1] 318733 0
Overall post-operative complications assessed using audit of hospital records. Examples: Abdominal collections, wound infection, pelvis sepsis and systemic sepsis
Timepoint [1] 318733 0
30-days post-operative
Primary outcome [2] 318746 0
Pelvic Sepsis assessed using audit of hospital records
Timepoint [2] 318746 0
30 days post-operative
Primary outcome [3] 318747 0
Systemic Sepsis using audit of hospital records
Timepoint [3] 318747 0
30 days post-operative
Secondary outcome [1] 365850 0
Length of hospital stay using audit of hospital records
Timepoint [1] 365850 0
Assessed at time of discharge
Secondary outcome [2] 365912 0
Readmission rates using audit of hospital records
Timepoint [2] 365912 0
30 days post-operatively

Eligibility
Key inclusion criteria
Patients who underwent an open or laparoscopic subtotal colectomy for severe colitis (including acute severe ulcerative colitis) at Royal Adelaide Hospital (RAH) in Adelaide, South Australia, over a 15-year period between January 1993 and August 2018.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients younger than 16 years old,
Patients who had proctocolectomy
Patients who had primary single-stage reconstructive surgery forming an ileorectal anastomosis (IRA) or ileal pouch anal anastomosis (IPAA)
Patients with missing operative or outcome data.

Study design
Purpose
Duration
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Statistical analyses were performed using GraphPad Prism software version 7 (GraphPad Software Inc., San Diego, CA). Continuous variables were expressed as mean (standard deviation) for parametric data and median (range) for non-parametric. Categorical and binary variables were summarised as a total followed by a percentage. The Fisher-exact test was used for smaller patient numbers (n < 5), and the chi-square test was used for larger patient numbers (n > 5) to analyze categorical variables. The Welch’s t-test was used for continuous parametric data, and the Mann-Witney U test was used for continuous non-parametric data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2018
Date of last participant enrolment
Anticipated
Actual
1/10/2018
Date of last data collection
Anticipated
Actual
1/10/2018
Sample size
Target
61
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12956 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 25427 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 301686 0
Hospital
Name [1] 301686 0
Royal Adelaide Hospital
Country [1] 301686 0
Australia
Primary sponsor type
Individual
Name
Sergei Bedrikovetski
Address
University of Adelaide, 4 North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 301406 0
Individual
Name [1] 301406 0
Tarik Sammour
Address [1] 301406 0
Room 5E 334 ,Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country [1] 301406 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302406 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 302406 0
Level 3, Roma Mitchell House, 136 North Terrace, Adelaide, SA, 5000
Ethics committee country [1] 302406 0
Australia
Date submitted for ethics approval [1] 302406 0
23/02/2018
Approval date [1] 302406 0
01/03/2018
Ethics approval number [1] 302406 0
HREC/18/CALHN/122, R20180217

Summary
Brief summary
The primary purpose of this study was to evaluate the current practice at a single inflammatory bowel (IBD) tertiary referral center, in order to identify the optimal surgical and medical management of the rectal stump after an subtotal colectomy for severe colitis. We hypothesize that an extra-fascial management of the rectal stump will have lower complication rates compared to an in-situ management of the rectal stump.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90130 0
Mr Sergei Bedrikovetski
Address 90130 0
University of Adelaide Health & Medical Sciences Building, 4 North Terrace, Adelaide SA 5000
Country 90130 0
Australia
Phone 90130 0
+61 406661954
Fax 90130 0
Email 90130 0
[email protected]
Contact person for public queries
Name 90131 0
A/Prof Tarik Sammour
Address 90131 0
Room 5E 334 ,Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 90131 0
Australia
Phone 90131 0
+61 432317318
Fax 90131 0
Email 90131 0
[email protected]
Contact person for scientific queries
Name 90132 0
Mr Sergei Bedrikovetski
Address 90132 0
University of Adelaide Health & Medical Sciences Building, 4 North Terrace, Adelaide SA 5000
Country 90132 0
Australia
Phone 90132 0
+61 406661954
Fax 90132 0
Email 90132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.