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Clinical Trials/NCT00782457
NCT00782457
Completed
Phase 3

Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer

Hospital Universitario Virgen de la Arrixaca0 sites200 target enrollmentJanuary 2002
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ConditionsRECTAL CANCER

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
RECTAL CANCER
Sponsor
Hospital Universitario Virgen de la Arrixaca
Enrollment
200
Primary Endpoint
Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.

Registry
clinicaltrials.gov
Start Date
January 2002
End Date
December 2010
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital Universitario Virgen de la Arrixaca

Eligibility Criteria

Inclusion Criteria

  • •Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin)
  • •Histology of adenocarcinoma

Exclusion Criteria

  • •Locally advanced disease (T4)
  • •Emergency surgery
  • •Rectal cancer over familial colic polyposis

Outcomes

Primary Outcomes

Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay

Time Frame: 1 month

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