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Drain Fluid Amylase as an early biomarker of anastomotic leak in low colorectal anastomoses

Drain Fluid Amylase and Lipase as early biomarkers of anastomotic leak in low colorectal anastomoses

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000057886
Acronym
NA
Enrollment
62
Registered
2021-01-22
Start date
2019-07-29
Completion date
2021-03-09
Last updated
2026-02-09

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 a serious complication of intestinal surgery, resulting in increased morbidity and mortality. This study aims to explore the simple and non-invasive approach of measuring the enzymes amylase and lipase in the drain fluid following a low extra-peritoneal anastomosis to detect AL at an early stage in the post-operative recovery. The hypothesis is based on the premise that luminal content of the colon is high in amylase and lipase and that drain fluid levels will rise above the normal serum reference range when an AL occurs. Who is it for? You may be eligible for this study if you are aged 18 or older, you have undergone a low or ultra low colorectal operation without a diverting loop ileostomy, and have had placement of a rectal tube and a pelvic drain at surgery. Patients undergoing the above surgical operations for any indication will be eligible for this study. Study details All participants enrolled in this study will have a sample of drain fluid collected daily from their surgical drain whilst the pelvic drain is in place. Insertion of pelvic drains is an element of the standard of care following colorectal surgery. It is hoped this research will determine whether enzymes such as amylase and lipase in fluids drained from an intestinal surgical site can indicate whether a patient has experienced an AL from their intestinal join following surgery, at an earlier time point than when diagnosed based on clinical signs.

Interventions

Measure amylase levels in drain fluid daily after low colorectal anastomoses as an early indicator of anastomotic leak. - a small sample of drain fluid will be collected daily while pelvic drain is in situ during hospital admission following colorectal surgery and samples will be sent to the local pathology service for measurement of amylase - the amylase levels in drain fluid at each collection while the drain is in-situ will be collected and correlated to the clinical course - clinical

Measure amylase levels in drain fluid daily after low colorectal anastomoses as an early indicator of anastomotic leak. - a small sample of drain fluid will be collected daily while pelvic drain is in situ during hospital admission following colorectal surgery and samples will be sent to the local pathology service for measurement of amylase - the amylase levels in drain fluid at each collection while the drain is in-situ will be collected and correlated to the clinical course - clinical course following surgery will be observed during admission (and data collected after patient has been discharged, retrospective data collection). - Follow up consultation at 6 weeks following surgery

Sponsors

Holy Spirit Private Hospital Northside
Lead SponsorHospital

Eligibility

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

Inclusion criteria

Low and ultra low colorectal surgery without a covering loop ileostomy Placement of a rectal tube Placement of a pelvic drain at surgery Any indication requiring low pelvic colorectal anastomosis

Exclusion criteria

Age less than 18 years Inability to give consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026