Clinical trial · Interventional
Abdominoperineal Extra-Elevators Rectal Resection for Cancer: Prone Position vs. Supine Position
Estudio A.P.PRO: Estrategia quirúrgica en la amputación Abdominoperineal cilíndrica Del Recto Por cáncer: posición de litotomía vs. Prono-navaja
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient recruitment rate
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominoperineal Resection | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abdominoperineal extra-elevators rectal resection for low lying rectal cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Supine position
- description
- Abdominoperineal resection - perineal time- in supine position
- interventionNames
- Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer
- type
- EXPERIMENTAL
- label
- Prone position
- description
- Abdominoperineal resection - perineal time- in prone position
- interventionNames
- Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer
Primary outcomes (1)
- measure
- Assessment of the circumferential resection margin
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDGarcia-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 19479978
- BACKGROUNDHeald 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 9711965
- BACKGROUNDFlor-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 24842689
- DERIVEDFrasson 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 26757199