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

This study is ongoing, but not recruiting participants.

First Received: October 29, 2008 No Changes Posted

Sponsored by:	Hospital Universitario Virgen de la Arrixaca
Information provided by:	Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier:	NCT00782457

Purpose

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	Intervention	Phase
Rectal Cancer	Procedure: RECTAL CANCER RESECTION	Phase III

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

Further study details as provided by Hospital Universitario Virgen de la Arrixaca:

Primary Outcome Measures:

Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	January 2002
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
OPEN SURGERY: Active Comparator	Procedure: RECTAL CANCER RESECTION
LAPAROSCOPIC SURGERY: Experimental	Procedure: RECTAL CANCER RESECTION

Eligibility

Genders Eligible for Study:	Both
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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	HUV Arrixaca ( Juan Lujan )
Study ID Numbers:	D-08-00770
Study First Received:	October 29, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00782457 History of Changes
Health Authority:	Spain: Ethics Committee

Study placed in the following topic categories:

Rectal Cancer
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Rectal Neoplasm

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009