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Drain Fluid Amylase Testing to Identify Anastomotic Leak in Patients Undergoing Ileal Pouch Surgery without an ileostomy

Drain Fluid Amylase as a sensitive Biomarker of Anastomotic Leak in Ileal Pouch Surgery Without a Covering Loop Ileostomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619001665123
Enrollment
20
Registered
2019-11-28
Start date
2018-08-27
Completion date
2020-08-31
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 tu

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.

Sponsors

Royal Brisbane Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Ileal pouch surgery no covering loop ileostomy able to provide consent

Exclusion criteria

covering loop ileostomy under 18 years of age

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026