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

NCT02163785 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2021-10-01

No results posted yet for this study

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

Conditions

Interventions

PROCEDURE

Abdominoperineal extra-elevators rectal resection for low lying rectal cancer

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

Sponsors & Collaborators

  • Fundacion Para La Investigacion Hospital La Fe

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Hospital Universitario La Fe

    lead OTHER

Principal Investigators

  • Matteo Frasson, MD, PhD · Hospital Universitario y Politecnico La Fe

  • Eduardo Garcia-Granero, MD, PhD, EBSQ-c · Hospital Universitario y Politecnico La Fe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02163785 on ClinicalTrials.gov