Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer
NCT02718729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2020-05-29
Summary
Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and esophageal anastomosis than the other parts of the alimentary tract due to technical difficulties in accessing these areas and their easily compromised blood supply.
Anastomotic leakage is the most feared complication following rectal resection and anastomosis. The incidence of anastomotic leakage ranges from 2.8% to more than 15%, with mortality rate more than 30%. Subclinical anastomotic failure may occur in up to 51% of patients.
Anastomotic leakage leads to increase the rate of secondary interventions, re-operations, longer postoperative hospital stay, increased cost, and major impact on the patient's quality of life. In the medium to long term, patient may be unfit for post-operative adjuvant therapy with decreased the disease survival. Furthermore anastomotic leakage itself may increase the local recurrence, a reduction in overall survival, and a large proportion of patients are left with a permanent stoma.
Conditions
- Anastomotic Leakage
Interventions
- PROCEDURE
-
Laparoscopic resection for rectal cancer
Formal curative radical laparoscopic rectal resection.
Sponsors & Collaborators
-
University of Rome Tor Vergata
collaborator OTHER -
Mansoura University
lead OTHER
Principal Investigators
-
Mostafa Shalaby, M,D., MSc. · Mansoura University/ University of Rome Tor Vergata
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-01
- Primary Completion
- 2017-01-01
- Completion
- 2017-06-01
Countries
- Egypt
- Italy
Study Locations
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