Ignite Creation Date:
2025-12-18 @ 8:41 AM
Ignite Modification Date:
2025-12-23 @ 10:48 PM
Study NCT ID:
NCT02163785
Status:
None
Last Update Posted:
2021-10-01 00:00:00
First Post:
2014-06-12 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Abdominoperineal Extra-Elevators Rectal Resection for Cancer: Prone Position vs. Supine Position
Sponsor:
None
Organization:
Study Overview
Official Title:
Estudio A.P.PRO: Estrategia quirúrgica en la amputación Abdominoperineal cilíndrica Del Recto Por cáncer: posición de litotomía vs. Prono-navaja
Status:
None
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPRO
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
Primary objective:
\- Pathological circumferential resection margin
Secondary objectives:
* 5 year oncological outcomes
* Morbimortality rates
* Surgical specimen quality
* Perineal hernia incidence
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: