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

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ClinicalTrials.gov Identifier: NCT00782457
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : March 18, 2015
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
RECTAL CANCER Procedure: RECTAL CANCER RESECTION Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2002
Actual Primary Completion Date : February 2007
Study Completion Date : December 2010

Arm Intervention/treatment
Active Comparator: OPEN SURGERY Procedure: RECTAL CANCER RESECTION
Experimental: LAPAROSCOPIC SURGERY Procedure: RECTAL CANCER RESECTION



Primary Outcome Measures :
  1. Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay [ Time Frame: 1 month ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juan Lujan, HUV Arrixaca
ClinicalTrials.gov Identifier: NCT00782457     History of Changes
Other Study ID Numbers: D-08-00770
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: October 2008

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases