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

La Fe University and Polytechnic Hospital

Status: Terminated

Conditions: Abdominoperineal Resection; Rectal Cancer

Treatments: Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT02163785

APPRO

Details and patient eligibility

About

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

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups

Supine position

Active Comparator group

Description:

Abdominoperineal resection - perineal time- in supine position

Treatment:

Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer

Prone position

Experimental group

Description:

Abdominoperineal resection - perineal time- in prone position

Treatment:

Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer