Anastomotic Leakage After Anterior Resection of Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03281070
• Other study ID #: CR-AL
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2017
• Last updated: December 27, 2017
• Start date: October 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: September 2017
• Source: Beijing Friendship Hospital
• Contact: Hongwei Yao, M.D.
• Phone: +8613611015609
• Email: yaohongwei[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leakage	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.	14 days after surgery