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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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 90 patients during three consecutive years.

Detailed Summary:
Sponsor: Umeå University

Current Primary Outcome: Blood flow measurements [ Time Frame: Start and end of operation ]

Laser-Doppler blood flow measurements of the rectal mucosa perfusion below and distal to the anastomosis.


Original Primary Outcome: Same as current

Current Secondary Outcome: Anastomotic leakage [ Time Frame: 90 days postoperatively ]

The occurrence of anastomotic leakage, as defined by the ISGRC.


Original Secondary Outcome: Same as current

Information By: Umeå University

Dates:
Date Received: March 24, 2015
Date Started: May 2015
Date Completion: September 2018
Last Updated: June 28, 2016
Last Verified: June 2016