NCT02163785

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

19 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

6.6 years

First QC Date

June 12, 2014

Last Update Submit

September 25, 2021

Conditions

Rectal CancerAbdominoperineal Resection

Keywords

Inferior rectal cancerAbdominoperineal resectionMiles operationSupine Miles operationProne Miles operationTotal mesorectal excisionCircumferential radial margin

Outcome Measures

Primary Outcomes (1)

  • 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.

    15-30 days after surgery date

Secondary Outcomes (1)

  • Histopathological quality of surgical specimen

    15-30 days after

Other Outcomes (2)

  • Oncological outcomes

    5 years

  • Morbidity of the perineal incision.

    1 day, 60 days ,1 ,2,3,4 and 5 years after surgery

Study Arms (2)

Supine position

ACTIVE COMPARATOR

Abdominoperineal resection - perineal time- in supine position

Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer

Prone position

EXPERIMENTAL

Abdominoperineal resection - perineal time- in prone position

Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer

Interventions

Abdominoperineal extra-elevators rectal resection for low lying rectal cancerPROCEDURE

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

Also known as: Abdominoperineal resection of the rectum, Abdominoperineal excision of the rectum, Abdominoperineal resection
Prone positionSupine position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary low lying rectal cancer involving or threatening anal sphincter complex as seen in MRI

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

Location

Hospital del SAS

Jerez de la Frontera, Andalusia, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Basque Country, Spain

Location

Hospital General

Medina del Campo, Castille and León, Spain

Location

Hospital Bellvitge

Barcelona, Catalonia, Spain

Location

Hospital del Mar

Barcelona, Catalonia, Spain

Location

Hospital Universitario Josep Trueta

Girona, Catalonia, Spain

Location

Hospital Universitario Parc Tauli

Sabadell, Catalonia, Spain

Location

Complexo Hospitalario Universitario

Ourense, Galicia, Spain

Location

Complejo Hospitalario Universitario

Vigo, Galicia, Spain

Location

Complejo Hospitalario

Pamplona, Navarre, Spain

Location

Hospital General Universitario

Elche, Valencia, Spain

Location

Hospital General

Requena, Valencia, Spain

Location

Hospital de Sagunto

Sagunto, Valencia, Spain

Location

Hospital Luis Alcanyis

Xàtiva, Valencia, Spain

Location

Hospital Universitario "Virgen de la Arrixaca"

Murcia, Spain

Location

Hospital Universitario y Politecnico La Fe

Valencia, 46026, Spain

Location

Hospital Arnau de Vilanova

Valencia, Spain

Location

Hospital Clinico Universitario

Valencia, Spain

Location

Related Publications (4)

  • 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.

    PMID: 19479978BACKGROUND

  • 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.

    PMID: 9711965BACKGROUND

  • 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.

    PMID: 24842689BACKGROUND

  • 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.

    PMID: 26757199DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Proctectomy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, ColorectalDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Matteo Frasson, MD, PhD

    Hospital Universitario y Politecnico La Fe

    PRINCIPAL INVESTIGATOR

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

    Hospital Universitario y Politecnico La Fe

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

June 1, 2014

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

October 1, 2021

Record last verified: 2021-09

Locations

ES(19)