Anastomotic Leakage After Anterior Resection of Rectal Cancer

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03281070

Enrollment

3000

Registered

2017-09-13

Start date

2017-10-01

Completion date

2018-05-01

Last updated

2017-12-28

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

Conditions

Rectal Cancer

Keywords

Anastomotic leakage, Anterior resection, Risk factors, Incidence, Rectal Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Anastomotic leakage	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.

Countries

China

Contacts

Primary ContactHongwei Yao, M.D.

yaohongwei@medmail.com.cn+8613611015609

Backup ContactJun Li, M.D.

lijunsy2002@163.com+8613811379656

Outcome results