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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00782457
First Posted: October 31, 2008
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Universitario Virgen de la Arrixaca
October 29, 2008
October 31, 2008
March 18, 2015
January 2002
February 2007   (Final data collection date for primary outcome measure)
Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay [ Time Frame: 1 month ]
Same as current
Complete list of historical versions of study NCT00782457 on ClinicalTrials.gov Archive Site
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Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer
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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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
RECTAL CANCER
Procedure: RECTAL CANCER RESECTION
  • Active Comparator: OPEN SURGERY
    Intervention: Procedure: RECTAL CANCER RESECTION
  • Experimental: LAPAROSCOPIC SURGERY
    Intervention: Procedure: RECTAL CANCER RESECTION
Lujan J, Valero G, Hernandez Q, Sanchez A, Frutos MD, Parrilla P. Randomized clinical trial comparing laparoscopic and open surgery in patients with rectal cancer. Br J Surg. 2009 Sep;96(9):982-9. doi: 10.1002/bjs.6662.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2010
February 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
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NCT00782457
D-08-00770
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Juan Lujan, HUV Arrixaca
Hospital Universitario Virgen de la Arrixaca
Not Provided
Not Provided
Hospital Universitario Virgen de la Arrixaca
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP