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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02401100
Enrollment
36
Registered
2015-03-27
Start date
2015-05-31
Completion date
2018-09-30
Last updated
2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak

Keywords

Rectal Neoplasms

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.

Interventions

None listed

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Planned anterior resection for rectal cancer * Willing to participate

Exclusion criteria

* Not willing to participate * Unable to consent

Design outcomes

Primary

MeasureTime frameDescription
Blood flow measurementsStart and end of operationLaser-Doppler blood flow measurements of the rectal mucosa perfusion below and distal to the anastomosis.

Secondary

MeasureTime frameDescription
Anastomotic leakage90 days postoperativelyThe occurrence of anastomotic leakage, as defined by the International Study Group for Rectal Cancer (ISREC).

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026