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Trial registered on ANZCTR


Registration number
ACTRN12619001665123
Ethics application status
Approved
Date submitted
7/08/2019
Date registered
28/11/2019
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Drain Fluid Amylase Testing to Identify Anastomotic Leak in Patients Undergoing Ileal Pouch Surgery without an ileostomy
Scientific title
Drain Fluid Amylase as a sensitive Biomarker of Anastomotic Leak in Ileal Pouch Surgery Without a Covering Loop Ileostomy
Secondary ID [1] 298749 0
none
Universal Trial Number (UTN)
U1111-1238-3570
Trial acronym
Linked study record
Clark, D. A., Cuda, T., Riddell, A., Radford-Smith, G., & Solomon, M. (2018). Drain fluid amylase as a sensitive biomarker for the early detection of anastomotic leakage in ileal pouch surgery. Colorectal Disease. 21(4), 460-464 The Official Journal of the Association of Coloproctology of Great Britain and Ireland,

This publication reports on the pilot phase (proof of principle) of the current study (Trial No:377982)

Health condition
Health condition(s) or problem(s) studied:
inflammatory bowel disease 313966 0
ileoanal anastomosis (J-pouch) surgery 313967 0
Condition category
Condition code
Surgery 312367 312367 0 0
Other surgery
Oral and Gastrointestinal 313522 313522 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
Eligible patients are identified by treating colorectal surgeon and invited to participate in the study. Participants interested in participating in the study receive information about the study and asked to provide written consent before being included. Participants provide written consent to allow access to patient medical records and a daily collection of drain fluid (10 ml) and a sample (10 ml) from the rectal tube on Day 1 post operatively. The daily collection of drain fluid and rectal tube sample presents no additional risk, discomfort or inconvenience for participants. Participation is voluntary with the option of withdrawal at any stage without consequence.
Drain fluid samples are collected daily for 5 days (or until drain is removed, whichever is later) for measurement of amylase levels.

An increase in drain fluid amylase is expected in the case of anastomotic leak, at an earlier timepoint than current diagnostics.
Intervention code [1] 315243 0
Early Detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320996 0
1. Daily amylase levels in the drain fluid post-operatively. The measurement of amylase in drain fluid is measured and reported by local pathology service.
Timepoint [1] 320996 0
Day 1, Day 2, Day 3, Day 4 and Day 5, post operatively, or until pelvic drain is removed.
Secondary outcome [1] 373642 0
Clinical course (anastomotic leak) following surgery is assessing by treating surgeon as per standard clinical practice (including daily observation of vital signs. Clinical observations are documented in patient medical chart.
Timepoint [1] 373642 0
6 weeks post surgery follow up appointment with treating surgeon
Secondary outcome [2] 377274 0
serum CRP
Timepoint [2] 377274 0
Day 3 post operative
Day 5 post operative
Secondary outcome [3] 377275 0
Hospital Length of Stay (LOS) is documented patient Discharge summary (medical records)
Timepoint [3] 377275 0
Day of discharge

Eligibility
Key inclusion criteria
Ileal pouch surgery
no covering loop ileostomy
able to provide consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
covering loop ileostomy
under 18 years of age

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
descriptive statistics
Chai squared
Correlation
Samples size was calculated from a pilot study

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/08/2018
Date of last participant enrolment
Anticipated
31/08/2020
Actual
Date of last data collection
Anticipated
15/10/2020
Actual
Sample size
Target
43
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14471 0
Holy Spirit Northside - Chermside
Recruitment hospital [2] 14472 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 14473 0
The Wesley Hospital - Auchenflower
Recruitment hospital [4] 14474 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 27487 0
4029 - Herston
Recruitment postcode(s) [2] 27486 0
4032 - Chermside
Recruitment postcode(s) [3] 27488 0
4066 - Auchenflower
Recruitment postcode(s) [4] 27489 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 303306 0
Hospital
Name [1] 303306 0
Royal Brisbane Hospital
Country [1] 303306 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane Hospital
Address
Butterfield St
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 303327 0
University
Name [1] 303327 0
University of Sydney
Address [1] 303327 0
50 Missenden Road
Camperdown NSW 2050
Country [1] 303327 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303840 0
Royal Brisbane Women's Hospital HREC
Ethics committee address [1] 303840 0
Royal Brisbane Women's Hospital HREC [EC00172]
Executive Suites
Dr James Mayne Building
Butterfield Street
Herston QLD 4029
Ethics committee country [1] 303840 0
Australia
Date submitted for ethics approval [1] 303840 0
Approval date [1] 303840 0
14/06/2018
Ethics approval number [1] 303840 0

Summary
Brief summary
Anastomotic leakage (AL) is the most significant complication in any intestinal operation with an anastomosis. Much work has gone into identifying patients at higher risk of AL pre-operatively . Early post-operative detection is also important, and a body of work has examined inflammatory markers, lipopolysaccharides and drain fluid proteins in patients undergoing colorectal anastomoses.

In patients undergoing restorative proctocolectomy and ileal pouch anal anastomosis (RP A drain is commonly placed to the pelvis during RP IPAA. This provides an opportunity to study the contents of the drain fluid in a simple and non-invasive way.

As the luminal contents of the small intestine are high in amylase, we wished to study its measurement in drain fluid as a biomarker of AL.

Ileal pouch surgery presents a unique opportunity to utilize drain fluid amylase (DFA) as a biomarker to detect anastomotic leakage when a defunctioning ileostomy is not employed. We hypothesize that a substantial rise in DFA is a sensitive biomarker of anastomotic leak. The primary aim is to evaluate the utility of measuring amylase in drain fluid and to relate this to the clinical post operative course. The secondary aim is to quantitate the intra-luminal values of amylase within the ileal pouch.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94986 0
A/Prof David A Clark
Address 94986 0
St Vincent's Private Hospital Northside
627 Rode Road
Chermside QLD 4032
Country 94986 0
Australia
Phone 94986 0
+61 733502088
Fax 94986 0
61733465169
Email 94986 0
David.Clark@doctors.org.uk
Contact person for public queries
Name 94987 0
Dr Aleks Edmundson
Address 94987 0
University of Qld
Health Sciences Building
Butterfield Street
Herston. QLD 4029
Country 94987 0
Australia
Phone 94987 0
+61 733465169
Fax 94987 0
Email 94987 0
aleksandra.edmundson@uq.edu.au
Contact person for scientific queries
Name 94988 0
A/Prof David A Clark
Address 94988 0
St Vincent's Private Hospital Northside
627 Rode Road
Chermside. QLD 4032
Country 94988 0
Australia
Phone 94988 0
+61 733502088
Fax 94988 0
61733465169
Email 94988 0
David.Clark@doctors.org.uk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
HREC approval prevents identifiable patient data to be available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3875Ethical approval    377982-(Uploaded-07-08-2019-18-34-35)-Study-related document.pdf
5490Study protocol  aleksandra.edmundson@uq.edu.au



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMulticenter Study of Drain Fluid Amylase as a Biomarker for the Detection of Anastomotic Leakage after Ileal Pouch Surgery Without a Diverting Ileostomy.2022https://dx.doi.org/10.1097/DCR.0000000000002376
N.B. These documents automatically identified may not have been verified by the study sponsor.