Biomarkers for colorectal anastomotic leakage
Not Applicable
Completed
- Conditions
- SurgeryAnastomotic leakage after rectal resection
- Registration Number
- ISRCTN84052649
- Lead Sponsor
- niversitair Ziekenhuis Leuven
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34706131/ (added 31/03/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 271
Inclusion Criteria
Patients who underwent partial mesorectal excision (PME) or total mesorectal excision (TME) with construction of a colorectal anastomosis
Exclusion Criteria
1. Pregnancy
2. Age < 18 years
3. No informed consent
4. No drain
5. Emergency surgery
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method There are no secondary outcome measures