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

NCT ID: NCT00782457

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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RECTAL CANCER

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OPEN SURGERY

Group Type ACTIVE_COMPARATOR

RECTAL CANCER RESECTION

Intervention Type PROCEDURE

LAPAROSCOPIC SURGERY

Group Type EXPERIMENTAL

RECTAL CANCER RESECTION

Intervention Type PROCEDURE

Interventions

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RECTAL CANCER RESECTION

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role lead

Responsible Party

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HUV Arrixaca

References

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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. doi: 10.1002/bjs.6662.

Reference Type DERIVED
PMID: 19644973 (View on PubMed)

Other Identifiers

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D-08-00770

Identifier Type: -

Identifier Source: org_study_id

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