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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Hospital Universitario Virgen de la Arrixaca.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier:
NCT00782457
First received: October 29, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

October 29, 2008
October 29, 2008
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
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Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer
Not Provided

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: 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00782457
D-08-00770
Not Provided
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