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Anastomotic Leakage After Anterior Resection of Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281070
Recruitment Status : Unknown
Verified September 2017 by Zhongtao Zhang, Beijing Friendship Hospital.
Recruitment status was:  Recruiting
First Posted : September 13, 2017
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Zhongtao Zhang, Beijing Friendship Hospital

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.

Condition or disease
Rectal Cancer

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Incidence and Risk Factors of Anastomotic Leakage After Anterior Resection of Rectal Cancer: a Multi-site Observational Study
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : May 1, 2018



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rectal cancer patients who underwent anterior resection with or without postoperative anastomotic leakage
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281070


Contacts
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Contact: Hongwei Yao, M.D. +8613611015609 yaohongwei@medmail.com.cn
Contact: Jun Li, M.D. +8613811379656 lijunsy2002@163.com

Locations
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China
Beijing Friendship Hospital Recruiting
Beijing, China
Contact: Hongwei Yao, M.D.    +8613611015609    yaohongwei@medmail.com.cn   
Sponsors and Collaborators
Beijing Friendship Hospital
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Responsible Party: Zhongtao Zhang, Department of General Surgery, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT03281070    
Other Study ID Numbers: CR-AL
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhongtao Zhang, Beijing Friendship Hospital:
Anastomotic leakage
Anterior resection
Risk factors
Incidence
Rectal Cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Anastomotic Leak
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