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

September 25, 2021 updated by: Matteo Frasson, Hospital Universitario La Fe

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain
        • Hospital Universitario "Virgen de la Arrixaca"
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe
      • Valencia, Spain
        • Hospital Arnau de Vilanova
      • Valencia, Spain
        • Hospital Clinico Universitario
    • Andalucia
      • Jerez, Andalucia, Spain
        • Hospital del SAS
    • Andalucía
      • Cordoba, Andalucía, Spain
        • Hospital Universitario Reina Sofia
    • Castilla Y Leon
      • Medina del Campo, Castilla Y Leon, Spain
        • Hospital General
    • Cataluña
      • Barcelona, Cataluña, Spain
        • Hospital Bellvitge
      • Barcelona, Cataluña, Spain
        • Hospital del Mar
      • Girona, Cataluña, Spain
        • Hospital Universitario Josep Trueta
      • Sabadell, Cataluña, Spain
        • Hospital Universitario Parc Tauli
    • Galicia
      • Orense, Galicia, Spain
        • Complexo Hospitalario Universitario
      • Vigo, Galicia, Spain
        • Complejo Hospitalario Universitario
    • Navarra
      • Pamplona, Navarra, Spain
        • Complejo Hospitalario
    • Pais Vasco
      • Donostia, Pais Vasco, Spain
        • Hospital Universitario Donostia
    • Valencia
      • Elche, Valencia, Spain
        • Hospital General Universitario
      • Requena, Valencia, Spain
        • Hospital General
      • Sagunto, Valencia, Spain
        • Hospital de Sagunto
      • Xativa, Valencia, Spain
        • Hospital Luis Alcanyis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Supine position
Abdominoperineal resection - perineal time- in supine position
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
Other Names:
  • Abdominoperineal resection of the rectum
  • Abdominoperineal excision of the rectum
  • Abdominoperineal resection
EXPERIMENTAL: Prone position
Abdominoperineal resection - perineal time- in prone position
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
Other Names:
  • Abdominoperineal resection of the rectum
  • Abdominoperineal excision of the rectum
  • Abdominoperineal resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the circumferential resection margin
Time Frame: 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.
15-30 days after surgery date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histopathological quality of surgical specimen
Time Frame: 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.
15-30 days after

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncological outcomes
Time Frame: 5 years
Compare the incidence of local oncological disease, distance metastasis and survival in a 5 year follow up time span.
5 years
Morbidity of the perineal incision.
Time Frame: 1 day, 60 days ,1 ,2,3,4 and 5 years after surgery
Evaluation the clinical outcome of the perineal wound in terms of infection, dehiscence, perineal hernia etc.
1 day, 60 days ,1 ,2,3,4 and 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Fe

Collaborators

Instituto de Salud Carlos III
Fundacion Para La Investigacion Hospital La Fe

Investigators

  • Principal Investigator: Matteo Frasson, MD, PhD, Hospital Universitario y Politécnico La Fe
  • Study Chair: Eduardo Garcia-Granero, MD, PhD, EBSQ-c, Hospital Universitario y Politécnico La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

January 1, 2021

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (ESTIMATE)

June 16, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 25, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APPRO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Cancer

Clinical Trials on Abdominoperineal extra-elevators rectal resection for low lying rectal cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe