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

NCT02401100 | Completed

• 1 other identifier: UmU-AL-01
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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 40 patients during three consecutive years.

Conditions

Anastomotic Leak

Keywords

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anastomotic leakage

  90 days postoperatively

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with rectal cancer who undergo anterior resection for rectal cancer at Umeå University Hospital.

You may qualify if:

• Planned anterior resection for rectal cancer
• Willing to participate

You may not qualify if:

• Not willing to participate
• Unable to consent

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Umeå University Hospital

Umeå, 90187, Sweden

Location

Related Publications (1)

• Back E, Brannstrom F, Svensson J, Rutegard J, Matthiessen P, Haapamaki MM, Rutegard M. Mucosal blood flow in the remaining rectal stump is more affected by total than partial mesorectal excision in patients undergoing anterior resection: a key to understanding differing rates of anastomotic leakage? Langenbecks Arch Surg. 2021 Sep;406(6):1971-1977. doi: 10.1007/s00423-021-02182-0. Epub 2021 May 18.

  PMID: 34008097 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Preoperative and postoperative blood samples. Postoperative drain fluid samples. Tissue samples from the perianastomotic region taken perioperatively.

MeSH Terms

Conditions

Anastomotic Leak; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Martin Rutegård, M.D., Ph.D.

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 27, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)