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

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.

Completed

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RECTAL CANCER RESECTION

Procedure

Primary outcomes

Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Hospital Universitario Virgen de la Arrixaca

Other

Registry information

Important dates

Study start: 2002
Primary completion: 2007
Study completion: 2010
First posted: Oct 31, 2008
Registry last updated: Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed