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

Not Applicable

Recruiting

• Conditions: Colorectal cancer; Anastomotic leak; Surgery - Other surgery; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12621000057886
• Lead Sponsor: Holy Spirit Private Hospital Northside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-22
• Last Update Posted: 1 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daily amylase levels in the drain fluid post-operatively. The measurement of amylase in drain fluid is measured and reported by local pathology service.[Day 1, Day 2, Day 3, Day 4 and Day 5, post operatively, or until pelvic drain is removed. ]

Secondary Outcome Measures

Name	Time	Method
Serum CRP [Day 3 post-operative<br>];Hospital Length of Stay (LOS), documented in discharge Summary (medical records)[Day of discharge];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.[ - Amylase levels will be observed daily following surgery until pelvic drain is removed<br>- Follow up appointment with treating surgeon at 6 weeks after surgery will be reported]