Anastomotic Leakage After Anterior Resection of Rectal Cancer

NCT03281070 | Unknown

• 1 other identifier: CR-AL
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rectal cancer patients who underwent anterior resection with or without postoperative anastomotic leakage

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hongwei Yao, M.D.

CONTACT

+8613611015609; yaohongwei@medmail.com.cn

Jun Li, M.D.

CONTACT

+8613811379656; lijunsy2002@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of General Surgery

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: October 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: December 28, 2017

Record last verified: 2017-09

Locations

CN (1)