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

Not Applicable

Terminated

• Conditions: Rectal Cancer; Abdominoperineal Resection
• Interventions: Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer

• Registration Number: NCT02163785
• Lead Sponsor: Hospital Universitario La Fe

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-16
• Primary Completion: 2021-01
• Study Completion: 2021-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-25
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supine position	Abdominoperineal extra-elevators rectal resection for low lying rectal cancer	Abdominoperineal resection - perineal time- in supine position
Prone position	Abdominoperineal extra-elevators rectal resection for low lying rectal cancer	Abdominoperineal resection - perineal time- in prone position

Primary Outcome Measures

Name	Time	Method
Assessment of the circumferential resection margin	15-30 days after surgery date	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.

Secondary Outcome Measures

Name	Time	Method
Histopathological quality of surgical specimen	15-30 days after	Comparison of the quality of the surgical specimen in terms of integrity of the circumferential resection margin, accidental iatrogenic rupture etc.

Trial Locations

Locations (18)

Hospital del SAS; 🇪🇸 Jerez, Andalucia, Spain

Hospital Universitario Reina Sofia; 🇪🇸 Cordoba, Andalucía, Spain

Hospital Bellvitge; 🇪🇸 Barcelona, Cataluña, Spain

Hospital del Mar; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Universitario Josep Trueta; 🇪🇸 Girona, Cataluña, Spain

Hospital Universitario Parc Tauli; 🇪🇸 Sabadell, Cataluña, Spain

Complejo Hospitalario Universitario; 🇪🇸 Vigo, Galicia, Spain

Complejo Hospitalario; 🇪🇸 Pamplona, Navarra, Spain

Complexo Hospitalario Universitario; 🇪🇸 Orense, Galicia, Spain

Hospital Universitario Donostia; 🇪🇸 Donostia, Pais Vasco, Spain

Hospital Luis Alcanyis; 🇪🇸 Xativa, Valencia, Spain

Hospital Universitario "Virgen de la Arrixaca"; 🇪🇸 Murcia, Spain

Hospital Universitario y Politecnico La Fe; 🇪🇸 Valencia, Spain

Hospital Arnau de Vilanova; 🇪🇸 Valencia, Spain

Hospital Clinico Universitario; 🇪🇸 Valencia, Spain

Hospital General Universitario; 🇪🇸 Elche, Valencia, Spain

Hospital General; 🇪🇸 Requena, Valencia, Spain

Hospital de Sagunto; 🇪🇸 Sagunto, Valencia, Spain