Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer

NCT02718729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2020-05-29

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02718729 on ClinicalTrials.gov