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

March 17, 2015 updated by: Hospital Universitario Virgen de la Arrixaca
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: OPEN SURGERY
Procedure: RECTAL CANCER RESECTION
EXPERIMENTAL: LAPAROSCOPIC SURGERY
Procedure: RECTAL CANCER RESECTION

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen de la Arrixaca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (ACTUAL)

February 1, 2007

Study Completion

December 1, 2010

Study Registration Dates

First Submitted

October 29, 2008

First Submitted That Met QC Criteria

October 29, 2008

First Posted (ESTIMATE)

October 31, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-08-00770

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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