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

RECTAL CANCER Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782457
• Other study ID #: D-08-00770
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2008
• Last updated: March 17, 2015
• Start date: January 2002
• Est. completion date: December 2010

Study information

• Verified date: October 2008
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• RECTAL CANCER

Intervention

Procedure:
• RECTAL CANCER RESECTION

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay		1 month	Yes