Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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This prospective study was designed to compare the quality of life after sphincter saving surgery and abdominoperineal resection. Because of ethical issues, it is difficult to conduct as a randomized trial. On the basis of tumor location, extent, and preoperative anal function, patient will be attributed to two different operative method groups. On the assumption that 10% of the patients are lost to follow-up at 1 year, at least 74 patients undergoing APR and 220 patients undergoing SPS will be recruited. The study will be continued until the target sample size will be achieved.

Official Title
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Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Abdominoperineal resection
* Procedure: Sphincter preservation surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sphincter preservation surgery<br>Temporary ileostomy with anal sphincter preservation | Procedure: Sphincter preservation surgery<br>* After high ligation of IMA, TME with autonomic nerve preservation, sphincter preservation and proctectomy with distal margin of more than 0.5cm in length and temporary ileostomy<br>* Other names: SPS;|
| Experimental: Abdominoperineal Resection<br>Permanent colostomy with total anal sphincter sacrifice | Procedure: Abdominoperineal resection<br>* After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.<br>* Other names: Miles' operation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life outcome | Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months). | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncologic outcomes | Oncologic outcomes (recurrence, survival) | 5 years | 
| Bladder function | Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months). | 3 years | 
| Sexual function | Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months). | 3 years | 
| Anal function | Only patients with sphincter preservation surgery, measured by manometry and MSKCC questionnaire at preoperative(baseline)and after ileostomy repair (12,24,36 months). | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Rectal Cancer, Sphincter preservation, Abdominoperineal resection, Quality of life, Sexual function, Urinary function, Oncologic outcome