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

NCT ID: NCT02401100

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-09-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Planned anterior resection for rectal cancer
• Willing to participate

Exclusion Criteria

• Not willing to participate
• Unable to consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Rutegård, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Umeå University Hospital

Umeå, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 34008097 (View on PubMed)

Other Identifiers

UmU-AL-01

Identifier Type: -

Identifier Source: org_study_id