Biomarkers for colorectal anastomotic leakage

Analysis of predictive parameters for evident anastomotic leakage - II

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN84052649

Enrollment

300

Registered

2018-10-23

Start date

2015-08-01

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Anastomotic leakage after rectal resection Surgery

Interventions

All patients received a pelvic drain during surgery which will kept in place for at least 3 postoperative days. Drain fluid was collected every morning on the first three postoperative days respecting

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who underwent partial mesorectal excision (PME) or total mesorectal excision (TME) with construction of a colorectal anastomosis

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Age < 18 years 3. No informed consent 4. No drain 5. Emergency surgery

Design outcomes

Primary

Measure	Time frame
Colorectal anastomotic leakage was defined as a clinically manifest insufficiency of the anastomosis, leading to a clinical state requiring treatment. It was confirmed by either endoscopy, CT-scan and/or contrast enema or reoperation. Treatment consisted of therapeutic antibiotics, drainage or a surgical re-intervention. The primary endpoint does not occur at a specific time point since it involves a postoperative complication. Follow-up ends at the first outpatient clinic visit after discharge.	—

Measure

Time frame

Colorectal anastomotic leakage was defined as a clinically manifest insufficiency of the anastomosis, leading to a clinical state requiring treatment. It was confirmed by either endoscopy, CT-scan and/or contrast enema or reoperation. Treatment consisted of therapeutic antibiotics, drainage or a surgical re-intervention. The primary endpoint does not occur at a specific time point since it involves a postoperative complication. Follow-up ends at the first outpatient clinic visit after discharge.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Belgium, Netherlands

Contacts

Public ContactCloe Sparreboom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026