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

Primary Purpose

Rectal Cancer, Abdominoperineal Resection

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer
Sponsored by
Hospital Universitario La Fe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Inferior rectal cancer, Abdominoperineal resection, Miles operation, Supine Miles operation, Prone Miles operation, Total mesorectal excision, Circumferential radial margin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital del SAS
  • Hospital Universitario Reina Sofia
  • Hospital General
  • Hospital Bellvitge
  • Hospital del Mar
  • Hospital Universitario Josep Trueta
  • Hospital Universitario Parc Tauli
  • Complexo Hospitalario Universitario
  • Complejo Hospitalario Universitario
  • Complejo Hospitalario
  • Hospital Universitario Donostia
  • Hospital General Universitario
  • Hospital General
  • Hospital de Sagunto
  • Hospital Luis Alcanyis
  • Hospital Universitario "Virgen de la Arrixaca"
  • Hospital Universitario y Politecnico La Fe
  • Hospital Arnau de Vilanova
  • Hospital Clinico Universitario

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Supine position

Prone position

Arm Description

Abdominoperineal resection - perineal time- in supine position

Abdominoperineal resection - perineal time- in prone position

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 12, 2014
Last Updated
September 25, 2021
Sponsor
Hospital Universitario La Fe
Collaborators
Fundacion Para La Investigacion Hospital La Fe, Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT02163785
Brief Title
Abdominoperineal Extra-Elevators Rectal Resection for Cancer: Prone Position vs. Supine Position
Acronym
APPRO
Official Title
Estudio A.P.PRO: Estrategia quirúrgica en la amputación Abdominoperineal cilíndrica Del Recto Por cáncer: posición de litotomía vs. Prono-navaja
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
insufficient recruitment rate
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Fe
Collaborators
Fundacion Para La Investigacion Hospital La Fe, Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Abdominoperineal Resection
Keywords
Inferior rectal cancer, Abdominoperineal resection, Miles operation, Supine Miles operation, Prone Miles operation, Total mesorectal excision, Circumferential radial margin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supine position
Arm Type
Active Comparator
Arm Description
Abdominoperineal resection - perineal time- in supine position
Arm Title
Prone position
Arm Type
Experimental
Arm Description
Abdominoperineal resection - perineal time- in prone position
Intervention Type
Procedure
Intervention Name(s)
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer
Other Intervention Name(s)
Abdominoperineal resection of the rectum, Abdominoperineal excision of the rectum, Abdominoperineal resection
Intervention Description
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex
Primary Outcome Measure Information:
Title
Assessment of the circumferential resection margin
Description
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.
Time Frame
15-30 days after surgery date
Secondary Outcome Measure Information:
Title
Histopathological quality of surgical specimen
Description
Comparison of the quality of the surgical specimen in terms of integrity of the circumferential resection margin, accidental iatrogenic rupture etc.
Time Frame
15-30 days after
Other Pre-specified Outcome Measures:
Title
Oncological outcomes
Description
Compare the incidence of local oncological disease, distance metastasis and survival in a 5 year follow up time span.
Time Frame
5 years
Title
Morbidity of the perineal incision.
Description
Evaluation the clinical outcome of the perineal wound in terms of infection, dehiscence, perineal hernia etc.
Time Frame
1 day, 60 days ,1 ,2,3,4 and 5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matteo Frasson, MD, PhD
Organizational Affiliation
Hospital Universitario y Politecnico La Fe
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eduardo Garcia-Granero, MD, PhD, EBSQ-c
Organizational Affiliation
Hospital Universitario y Politecnico La Fe
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital del SAS
City
Jerez
State/Province
Andalucia
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
State/Province
Andalucía
Country
Spain
Facility Name
Hospital General
City
Medina del Campo
State/Province
Castilla Y Leon
Country
Spain
Facility Name
Hospital Bellvitge
City
Barcelona
State/Province
Cataluña
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
State/Province
Cataluña
Country
Spain
Facility Name
Hospital Universitario Josep Trueta
City
Girona
State/Province
Cataluña
Country
Spain
Facility Name
Hospital Universitario Parc Tauli
City
Sabadell
State/Province
Cataluña
Country
Spain
Facility Name
Complexo Hospitalario Universitario
City
Orense
State/Province
Galicia
Country
Spain
Facility Name
Complejo Hospitalario Universitario
City
Vigo
State/Province
Galicia
Country
Spain
Facility Name
Complejo Hospitalario
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
Hospital Universitario Donostia
City
Donostia
State/Province
Pais Vasco
Country
Spain
Facility Name
Hospital General Universitario
City
Elche
State/Province
Valencia
Country
Spain
Facility Name
Hospital General
City
Requena
State/Province
Valencia
Country
Spain
Facility Name
Hospital de Sagunto
City
Sagunto
State/Province
Valencia
Country
Spain
Facility Name
Hospital Luis Alcanyis
City
Xativa
State/Province
Valencia
Country
Spain
Facility Name
Hospital Universitario "Virgen de la Arrixaca"
City
Murcia
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
Country
Spain
Facility Name
Hospital Clinico Universitario
City
Valencia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19479978
Citation
Garcia-Granero E, Faiz O, Munoz E, Flor B, Navarro S, Faus C, Garcia-Botello SA, Lledo S, Cervantes A. Macroscopic assessment of mesorectal excision in rectal cancer: a useful tool for improving quality control in a multidisciplinary team. Cancer. 2009 Aug 1;115(15):3400-11. doi: 10.1002/cncr.24387.
Results Reference
background
PubMed Identifier
9711965
Citation
Heald RJ, Moran BJ, Ryall RD, Sexton R, MacFarlane JK. Rectal cancer: the Basingstoke experience of total mesorectal excision, 1978-1997. Arch Surg. 1998 Aug;133(8):894-9. doi: 10.1001/archsurg.133.8.894.
Results Reference
background
PubMed Identifier
24842689
Citation
Flor-Lorente B, Frasson M, Montilla E. Extralevator abdominoperineal resection in the prone position. Cir Esp. 2014 Mar;92 Suppl 1:30-9. doi: 10.1016/S0009-739X(14)70006-5. English, Spanish.
Results Reference
background
PubMed Identifier
26757199
Citation
Frasson M, Garcia-Granero E. Reply to Kelly et al. Colorectal Dis. 2016 Mar;18(3):312-3. doi: 10.1111/codi.13272. No abstract available.
Results Reference
derived

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

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