Anastomotic Leakage After Anterior Resection for Rectal Cancer - Predictive Biomarkers and Rectal Blood Flow

Anastomotic Leak Clinical Trial

Official title:

Anastomotic Leakage After Anterior Resection for Rectal Cancer - Predictive Biomarkers and Rectal Blood Flow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401100
• Other study ID #: UmU-AL-01
• Status: Completed
• Start date: May 2015
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether reduced rectal blood flow is associated with the extent of surgery when performing an operation to remove rectal cancer. The investigators also aim to describe any relation of reduced rectal blood flow, as well as raised inflammatory biomarkers in blood and tissue, to the occurrence of anastomotic leakage. The patients will be recruited at Umeå University Hospital and all patients who are planned to undergo anterior resection for rectal cancer and able to consent are eligible for this study. Rectal blood flow measurements will be conducted with Laser-Doppler technology using noninvasive measuring probes. Preoperative and postoperative blood sampling as well as postoperative drain fluid collection will take place. Perianastomotic tissue will also be collected. In the postoperative period, any occurrence of surgical complications especially anastomotic leakage, will be noted. Blood flow and biomarkers will be assessed in relation to type of mesorectal excision (total or partial) and correlated to anastomotic leakage. Standard statistical tools will be utilized, such as parametric, non-parametric tests and logistic regression, as appropriate. The study will recruit approximately 40 patients during three consecutive years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Planned anterior resection for rectal cancer

• Willing to participate

Exclusion Criteria:

• Not willing to participate

• Unable to consent

Related Conditions & MeSH terms

• Anastomotic Leak

Locations

Country	Name	City	State
Sweden	Umeå University Hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood flow measurements	Laser-Doppler blood flow measurements of the rectal mucosa perfusion below and distal to the anastomosis.	Start and end of operation
Secondary	Anastomotic leakage	The occurrence of anastomotic leakage, as defined by the International Study Group for Rectal Cancer (ISREC).	90 days postoperatively