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

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ClinicalTrials.gov Identifier: NCT02163785
Recruitment Status : Recruiting
First Posted : June 16, 2014
Last Update Posted : August 11, 2020
Sponsor:
Collaborators:
Fundacion Para La Investigacion Hospital La Fe
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Matteo Frasson, 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

Condition or disease Intervention/treatment Phase
Rectal Cancer Abdominoperineal Resection Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Estudio A.P.PRO: Estrategia quirúrgica en la amputación Abdominoperineal cilíndrica Del Recto Por cáncer: posición de litotomía vs. Prono-navaja
Study Start Date : June 2014
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163785


Contacts
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Contact: Matteo Frasson, MD, PhD +34633236008 dr.frasson.matteo@gmail.com

Locations
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Sponsors and Collaborators
Hospital Universitario La Fe
Fundacion Para La Investigacion Hospital La Fe
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Matteo Frasson, MD, PhD Hospital Universitario y Politecnico La Fe
Study Chair: Eduardo Garcia-Granero, MD, PhD, EBSQ-c Hospital Universitario y Politecnico La Fe
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matteo Frasson, MD, PhD, Hospital Universitario La Fe
ClinicalTrials.gov Identifier: NCT02163785    
Other Study ID Numbers: APPRO
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Keywords provided by Matteo Frasson, Hospital Universitario La Fe:
Inferior rectal cancer
Abdominoperineal resection
Miles operation
Supine Miles operation
Prone Miles operation
Total mesorectal excision
Circumferential radial margin
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases