Trial Details

Recruiting
Basic Information
Clinical ID c2591
Identifier ACTRN12619001665123
Trial Title Drain Fluid Amylase as a sensitive Biomarker of Anastomotic Leak in Ileal Pouch Surgery Without a Covering Loop Ileostomy
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions inflammatory bowel disease;ileoanal anastomosis (J-pouch) surgery; inflammatory bowel disease ileoanal anastomosis (J-pouch) surgery;Surgery - Other surgery;Oral and Gastrointestinal - Inflammatory bowel disease
Interventions 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.
Participant Information
Sponsor Royal Brisbane Hospital
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -