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Clinical Trials/NCT03281070
NCT03281070
Unknown
Not Applicable

The Incidence and Risk Factors of Anastomotic Leakage After Anterior Resection of Rectal Cancer: a Multi-site Observational Study

Beijing Friendship Hospital1 site in 1 country3,000 target enrollmentStarted: October 1, 2017Last updated:
ConditionsRectal Cancer

Overview

Phase
Not Applicable
Enrollment
3,000
Locations
1
Primary Endpoint
Anastomotic leakage

Overview

Brief Summary

Anastomotic leakage (AL) is one of the most-feared postoperative complications after anterior resection of rectal cancer. This complication compromises both short term and long term outcome of patients. The incidence of AL after anterior resection was approximately 6-11%. Although several risk factors for AL such as male sex, smoking, tumor location, longer operative time, intraoperative blood loss had been reported in previous studies, the incidence of AL did not meet a significant decrease. So far there is no multi-site observational study on incidence and risk factors of AL after anterior resection in China, therefore this study aims to work on this issue and provide evidence for clinical practice.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • adenocarcinoma of the rectum by biopsy
  • single lesion
  • anterior resection was performed
  • anastomosis using circular stapler

Exclusion Criteria

  • history of colorectal cancer surgery
  • emergency surgery because of bowel obstruction, bleeding or perforation
  • colo-anal anastomosis
  • subtotal colectomy
  • total colectomy
  • abdominal perineal resection
  • Hartmann procedure
  • pull out anastomosis

Outcomes

Primary Outcomes

Anastomotic leakage

Time Frame: 14 days after surgery

Anastomotic leakage is defined as a defect of the intestinal wall integrity at the colorectal anastomotic site leading to a communication between the intra- and extraluminal compartments.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhongtao Zhang

Department of General Surgery

Beijing Friendship Hospital

Study Sites (1)

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