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

Phase 3
Completed
Conditions
RECTAL CANCER
Interventions
Procedure: RECTAL CANCER RESECTION
Registration Number
NCT00782457
Lead Sponsor
Hospital Universitario Virgen de la Arrixaca
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LAPAROSCOPIC SURGERYRECTAL CANCER RESECTION-
OPEN SURGERYRECTAL CANCER RESECTION-
Primary Outcome Measures
NameTimeMethod
Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay1 month
Secondary Outcome Measures
NameTimeMethod
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