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

Virgen de la Arrixaca University Clinical Hospital (HCUVA)

Status and phase: Completed; Phase 3

Conditions: RECTAL CANCER

Treatments: Procedure: RECTAL CANCER RESECTION

Study type: Interventional

Funder types: Other

Identifiers

NCT00782457

D-08-00770

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

OPEN SURGERY

Active Comparator group

Treatment:

Procedure: RECTAL CANCER RESECTION

LAPAROSCOPIC SURGERY

Experimental group

Treatment:

Procedure: RECTAL CANCER RESECTION