Clinical trial · Interventional
Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial
Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial
- 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)
Sphincter preservation surgery in low rectal cancer has been increased due to better understanding of tumor biology and advances in surgical technology. Furthermore, a majority of patients prefer sphincter preservation rather than living with permanent colostomy. But it is not clear whether sphincter preservation is directly related with better quality of life. There have been many studies comparing sphincter preservation surgery and abdominoperineal resection in many aspects including oncologic and functional outcomes, and the quality of life. However, the conclusion remains controversial because of the different results between studies.
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 |
|---|---|---|---|
| Abdominoperineal resection | Procedure | — | UNRESOLVED |
| Sphincter preservation surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sphincter preservation surgery
- description
- Temporary ileostomy with anal sphincter preservation
- interventionNames
- Procedure: Sphincter preservation surgery
- type
- EXPERIMENTAL
- label
- Abdominoperineal Resection
- description
- Permanent colostomy with total anal sphincter sacrifice
- interventionNames
- Procedure: Abdominoperineal resection
Primary outcomes (1)
- measure
- Quality of life outcome
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Low rectal cancer (5cm from anal verge by surgeon's digital rectal exam / rigid rectoscopy) * Patient who understands and accepts to sign the informed consent form * Confirmed preoperative colonoscopic biopsy (adenocarcinoma) * Proper bone marrow function * Proper renal function * Proper liver function * No severe comorbidity Exclusion Criteria: * Metastatic lesion detected in preoperative assessment * Previous history of cancer disease. (except patients with skin cancer) * Severe heart disease, congestive heart disease. * Severe lung disease, respiratory failure. * Mental illness. * Invasion to prostate, bladder and combined resection needed (partial or radical.• Legally prohibited for clinical trial. * Pregnancy or breast feeding. * Previous disease or disability expected to influence the assessment of postoperative quality of life.
References
Publications (1)
- DERIVEDKang SB, Cho JR, Jeong SY, Oh JH, Ahn S, Choi S, Kim DW, Lee BH, Youk EG, Park SC, Heo SC, Lee DS, Ryoo SB, Park JW, Park HC, Lee SM, Kang SI, Kim MH, Oh HK, Shin R, Kim MJ, Lee KH, Kim YH, Kim JS, Lee KW, Lee HS, Kim HJ, Park YS, Sohn DK, Park KJ; Seoul Colorectal Research Group (SECOG). Quality of life after sphincter preservation surgery or abdominoperineal resection for low rectal cancer (ASPIRE): A long-term prospective, multicentre, cohort study. Lancet Reg Health West Pac. 2020 Dec 28;6:100087. doi: 10.1016/j.lanwpc.2020.100087. eCollection 2021 Jan. PMID 34327411