Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000809730
Ethics application status
Approved
Date submitted
29/03/2022
Date registered
9/06/2022
Date last updated
2/04/2024
Date data sharing statement initially provided
9/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A multicentre randomised controlled trial of the modified Kono S anastomosis versus the stapled side to side anastomosis after ileocolic resection for Crohn’s disease
Scientific title
A multicentre randomised controlled trial of the effect of the modified Kono S anastomosis versus the stapled side to side anastomosis on disease recurrence after ileocolic resection for Crohn’s disease
Secondary ID [1] 306726 0
none
Universal Trial Number (UTN)
U1111-1276-0767
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 325711 0
ileocolic resection 326074 0
Condition category
Condition code
Oral and Gastrointestinal 323055 323055 0 0
Crohn's disease
Surgery 323386 323386 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgical procedure: Modified Kono S anastomosis after ileocolic resection.
The intestine is transected by use of a linear staple cutter such that the mesentery is in the middle of the staple line and at a 90° angle to it. Then, the staple lines are sutured together transversely to create a supporting column that is designed to support the eventual dimension of the anastomosis. Longitudinal enterotomies of 7 cm length are then performed at the antimesenteric aspect, beginning 1 cm from the supporting column. The anastomosis is then created transversely in a hand-sewn fashion.
Operative time: median:256 min
Adherence and Quality Assurance (QA) documented in surgical report
Surgical procedure preformed by: Accredited surgeon with training in Kono-S anastomosis,
-must be a member of Colorectal Society of Surgeons Australia and New Zealand (CSSANZ),
-experience with Inflammatory Bowel Disease (IBD) surgical management,
-a minimum of 20 ileocolic resections
- express interest in the multi-centre randomised controlled trial investigating the effect of Kono-S anastomotic approach
Intervention code [1] 323171 0
Treatment: Surgery
Comparator / control treatment
Surgical Procedure: The stapled side to side anastomosis after ileocolic resection for Crohn's disease. Surgical procedure involves; two cut ends of the bowel are placed side to side and the two forks of the stapling device are placed through open bowel ends to join.
Operative time: median 206mins
Adherence and QA documented in surgical report
- surgeon must be a member of Colorectal Society of Surgeons Australia and New Zealand (CSSANZ),
experience with Inflammatory Bowel Disease (IBD) surgical management,
- a minimum of 20 ileocolic resections
- express interest in the multi-centre randomised controlled trial investigating the effect of Kono-S anastomotic approach
Control group
Active

Outcomes
Primary outcome [1] 330815 0
Endoscopic recurrence observed on post-operative colonoscopy, measured using Rutgeerts Score (i2b or greater)
Timepoint [1] 330815 0
Six months post surgery
Secondary outcome [1] 407689 0
Surgical recurrence;
Requirement for further surgical management assessed by accessing patient electronic medical records by colorectal surgeon
Timepoint [1] 407689 0
12 months,
24 months,
3 years,
4 years and
5 years post index surgery
Secondary outcome [2] 408845 0
Quality of Life measured by Work Productivity and Activity Impairment in Crohn's Disease (WPAI-CD)
Timepoint [2] 408845 0
6 month
12 month
18 month
2 years
3 years,
4 years,
5 years post surgery
Secondary outcome [3] 408846 0
Biochemical recurrence
measured by faecal calprotectin, serum markers (CRP, ESR, Albumin, platelet count, ferritin)
Timepoint [3] 408846 0
6 month,
12 month,
2 years,
3 years,
4 years,
5 years post surgery
Secondary outcome [4] 408847 0
Symptomatic recurrence, measured by Harvey Bradshaw index (HBI), short inflammatory
Timepoint [4] 408847 0
6 months,
1 year,
2 years,
3years,
4 years
5 years post surgery
Secondary outcome [5] 409379 0
Inflammatory Bowel Disease - Disability index (IBD-DI),
Timepoint [5] 409379 0
6 months,
1 year,
2 years,
3years,
4 years
5 years post surgery
Secondary outcome [6] 409380 0
mental health assessments measured by a composite of Hospital and Anxiety Depression Scale (HADS), Patient-Reported Outcomes Measurement Information System (PROMIS) and Depression Anxiety Stress Scale (DASS))
Timepoint [6] 409380 0
6 months,
1 year,
2 years,
3years,
4 years
5 years post surgery
Secondary outcome [7] 409381 0
Symptomatic recurrence assessed by Crohn’s disease activity index (CDAI)
Timepoint [7] 409381 0
6 months,
1 year,
2 years,
3years,
4 years
5 years post surgery
Secondary outcome [8] 409382 0
Symptomatic occurrence measured by bowel disease questionnaire (SIBDQ)
Timepoint [8] 409382 0
6 months,
1 year,
2 years,
3years,
4 years
5 years post surgery

Eligibility
Key inclusion criteria
Adults, 18 years and over.
Crohn’s disease as diagnosed in accordance with the Lennard-Jones criteria.
First or second ileocolic resection.
Willingness to comply with study requirements and follow up.
Surgery to be performed within 30 days of randomization.
Provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency surgery where randomisation or informed consent is not possible.
Two or more prior ileocolic resections.
Oral Steroids at 20mg prednisone or over for 4 weeks or equivalent, prior to surgery.
Any patient whose medical condition requires a stoma.
Pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be allocated by main study site coordinator, independent of the surgeon.

allocation will involve contacting the holder of the allocation schedule (main study site coordinator) who will be "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data will be presented either as mean ± standard deviation for continuous, normally distributed variables or as median and interquartile range for nonparametric data. Univariate analysis will be performed using the independent Student’s t-test for parametric continuous data and Mann–Whitney U -test for nonparametric continuous data. Fisher’s exact test and Chi-squared test will be used to compare discrete variables. A p value <0.05 is considered statistically significant. Statistical analysis will be performed using IBM SPSS software (SPSS Statistics 22.0, Inc., Chicago, IL, USA) and GraphPad Prism 8 (GraphPad, San Diego, California, USA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
11/08/2023
Date of last participant enrolment
Anticipated
30/12/2024
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
65
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22064 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 22065 0
Holy Spirit Northside - Chermside
Recruitment postcode(s) [1] 37186 0
4029 - Herston
Recruitment postcode(s) [2] 37187 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 311057 0
Other Collaborative groups
Name [1] 311057 0
Brisbane Colorectal Research Unit
Country [1] 311057 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane Brisbane & Women's Hospital
Address
Butterfield Street
Herston 4029
Queensland
Australia
Country
Australia
Secondary sponsor category [1] 312477 0
None
Name [1] 312477 0
Address [1] 312477 0
Country [1] 312477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310602 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 310602 0
Ethics committee country [1] 310602 0
Australia
Date submitted for ethics approval [1] 310602 0
01/05/2023
Approval date [1] 310602 0
01/09/2023
Ethics approval number [1] 310602 0
Ethics committee name [2] 313933 0
St Vincent's Private Hospital Northside
Ethics committee address [2] 313933 0
Ethics committee country [2] 313933 0
Australia
Date submitted for ethics approval [2] 313933 0
04/09/2023
Approval date [2] 313933 0
07/09/2023
Ethics approval number [2] 313933 0
HREC_22-13_DCLA

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118226 0
Prof David Clark
Address 118226 0
St Vincent’s Private Hospital Northside
627 Rode Road
Chermside QLD 4032
Brisbane. .
AUSTRALIA
Country 118226 0
Australia
Phone 118226 0
+61 7 3350 2088
Fax 118226 0
+61 7 3350 2333
Email 118226 0
[email protected]
Contact person for public queries
Name 118227 0
David Clark
Address 118227 0
St Vincent’s Private Hospital Northside
627 Rode Road
Chermside QLD 4032
Brisbane. .
AUSTRALIA
Country 118227 0
Australia
Phone 118227 0
+61 7 3350 2088
Fax 118227 0
+61 7 3350 2333
Email 118227 0
[email protected]
Contact person for scientific queries
Name 118228 0
David Clark
Address 118228 0
St Vincent’s Private Hospital Northside
627 Rode Road
Chermside QLD 4032
Brisbane. .
AUSTRALIA
Country 118228 0
Australia
Phone 118228 0
+61 7 3350 2088
Fax 118228 0
+61 7 3350 2333
Email 118228 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15617Other  [email protected] From Principal Investigator



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.