Abdominoperineal Extra-Elevators Rectal Resection for Cancer: Prone Position vs. Supine Position

Hospital Universitario La Fe280 enrolled

Overview

Prospective multicenter randomized controlled trial comparing the prone vs. the supine position of the perineal time of the Miles operation in patients with advanced rectal cancer. Primary objective: \- Pathological circumferential resection margin Secondary objectives: * 5 year oncological outcomes * Morbimortality rates * Surgical specimen quality * Perineal hernia incidence

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

280

Conditions

Rectal Cancer Abdominoperineal Resection

Interventions

Abdominoperineal extra-elevators rectal resection for low lying rectal cancerPROCEDURE

Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with primary low lying rectal cancer involving or threatening anal sphincter complex as seen in MRI Exclusion Criteria: * American Society of Anaesthesiologists classification of Physical Health (ASA) IV patients * Locally palliative purpose of the operation * Age \< 18 years * Preoperative indication for pelvic exenteration * Pregnancy * Lack of patients consent

Locations (19)

Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

Hospital del SAS

Jerez de la Frontera, Andalusia, Spain

Outcomes

Primary Outcomes

Assessment of the circumferential resection margin

Histopathological report of the circumferential resection margin of the surgical specimen obtained in patients that underwent perineal time of Miles procedure in prone vs supine position.

Time frame: 15-30 days after surgery date

Secondary Outcomes

Histopathological quality of surgical specimen

Comparison of the quality of the surgical specimen in terms of integrity of the circumferential resection margin, accidental iatrogenic rupture etc.

Time frame: 15-30 days after

Data from ClinicalTrials.gov

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