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

Study Overview
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Brief Summary
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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

Official Title
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Estudio A.P.PRO: Estrategia quirúrgica en la amputación Abdominoperineal cilíndrica Del Recto Por cáncer: posición de litotomía vs. Prono-navaja

Conditions
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Rectal Cancer, Abdominoperineal Resection

Intervention / Treatment
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* Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supine position<br>Abdominoperineal resection - perineal time- in supine position | Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer<br>* Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex<br>* Other names: Abdominoperineal resection;|
| Experimental: Prone position<br>Abdominoperineal resection - perineal time- in prone position | Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer<br>* Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex<br>* Other names: Abdominoperineal resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15-30 days after surgery date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15-30 days after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inferior rectal cancer, Abdominoperineal resection, Miles operation, Supine Miles operation, Prone Miles operation, Total mesorectal excision, Circumferential radial margin