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

NCT ID: NCT02163785

Last Updated: 2021-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2021-01-31

Brief Summary

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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

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Conditions

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Rectal Cancer Abdominoperineal Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Supine position

Abdominoperineal resection - perineal time- in supine position

Group Type ACTIVE_COMPARATOR

Abdominoperineal extra-elevators rectal resection for low lying rectal cancer

Intervention Type PROCEDURE

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

Prone position

Abdominoperineal resection - perineal time- in prone position

Group Type EXPERIMENTAL

Abdominoperineal extra-elevators rectal resection for low lying rectal cancer

Intervention Type PROCEDURE

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

Interventions

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Abdominoperineal extra-elevators rectal resection for low lying rectal cancer

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

Intervention Type PROCEDURE

Other Intervention Names

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Abdominoperineal resection of the rectum Abdominoperineal excision of the rectum Abdominoperineal resection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Para La Investigacion Hospital La Fe

OTHER

Sponsor Role collaborator

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Hospital Universitario La Fe

OTHER

Sponsor Role lead

Responsible Party

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Matteo Frasson

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matteo Frasson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario y Politecnico La Fe

Eduardo Garcia-Granero, MD, PhD, EBSQ-c

Role: STUDY_CHAIR

Hospital Universitario y Politecnico La Fe

Locations

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Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

Site Status

Hospital del SAS

Jerez de la Frontera, Andalusia, Spain

Site Status

Hospital Universitario Donostia

Donostia / San Sebastian, Basque Country, Spain

Site Status

Hospital General

Medina del Campo, Castille and León, Spain

Site Status

Hospital Bellvitge

Barcelona, Catalonia, Spain

Site Status

Hospital del Mar

Barcelona, Catalonia, Spain

Site Status

Hospital Universitario Josep Trueta

Girona, Catalonia, Spain

Site Status

Hospital Universitario Parc Tauli

Sabadell, Catalonia, Spain

Site Status

Complexo Hospitalario Universitario

Ourense, Galicia, Spain

Site Status

Complejo Hospitalario Universitario

Vigo, Galicia, Spain

Site Status

Complejo Hospitalario

Pamplona, Navarre, Spain

Site Status

Hospital General Universitario

Elche, Valencia, Spain

Site Status

Hospital General

Requena, Valencia, Spain

Site Status

Hospital de Sagunto

Sagunto, Valencia, Spain

Site Status

Hospital Luis Alcanyis

Xàtiva, Valencia, Spain

Site Status

Hospital Universitario "Virgen de la Arrixaca"

Murcia, , Spain

Site Status

Hospital Universitario y Politecnico La Fe

Valencia, , Spain

Site Status

Hospital Arnau de Vilanova

Valencia, , Spain

Site Status

Hospital Clinico Universitario

Valencia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 19479978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9711965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24842689 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26757199 (View on PubMed)

Other Identifiers

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APPRO

Identifier Type: -

Identifier Source: org_study_id

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