Clinical trial · Interventional
Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer
Randomized Clinical Trial of Conventional Versus Individual Extralevator Abdominoperineal Excision for Locally Advanced Lower Rectal Cancer
NCT02036112CI-TRIAL-00013455ELAPEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE versus Individual ELAPE.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional ELAPE | Procedure | — | UNRESOLVED |
| Individual ELAPE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Individual ELAPE
- description
- Patients will receive Individual ELAPE technique
- interventionNames
- Procedure: Individual ELAPE
- type
- EXPERIMENTAL
- label
- Conventional ELAPE
- description
- Patients with advanced lower rectal cancer will receive conventional EALPE technique
- interventionNames
- Procedure: conventional ELAPE
Primary outcomes (1)
- measure
- The perioperative morbidity
- timeFrame
- three years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Tumor within 5 cm of the anal verge or with a very narrow pelvis * T3-T4 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination or a low tumor is fixed or tethered at rectal examination * Absence of distant metastases * Absence of intestinal obstruction Exclusion Criteria: * T1-T2 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination * With distant metastases * With intestinal obstruction * Pregnancy or lactation * Allergic constitution to heterogeneous protein * With operation contraindication
References
Publications (1)
- BACKGROUNDHan JG, Wang ZJ, Wei GH, Gao ZG, Yang Y, Zhao BC. Randomized clinical trial of conventional versus cylindrical abdominoperineal resection for locally advanced lower rectal cancer. Am J Surg. 2012 Sep;204(3):274-82. doi: 10.1016/j.amjsurg.2012.05.001. PMID 22920402