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OpenTrials
Completed

NCT Number: NCT02401100

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Planned anterior resection for rectal cancer
  • Willing to participate

Exclusion criteria

  • Not willing to participate
  • Unable to consent

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Anastomotic leakage

    Time frame: 90 days postoperatively

    The occurrence of anastomotic leakage, as defined by the International Study Group for Rectal Cancer (ISREC).

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2015
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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