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

Hospital Universitario Virgen de la Arrixaca200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

RECTAL CANCER

Interventions

RECTAL CANCER RESECTIONPROCEDURE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 1 month

Data from ClinicalTrials.gov

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