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

Not Applicable

Completed

Interventions: Procedure: Abdominoperineal resection
Procedure: Sphincter preservation surgery

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Abdominoperineal Resection	Abdominoperineal resection	Permanent colostomy with total anal sphincter sacrifice
Sphincter preservation surgery	Sphincter preservation surgery	Temporary ileostomy with anal sphincter preservation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (6): Hallym University College of Medicine
🇰🇷
Anyang, Gyeong-gi, Korea, Republic of
Seoul National University Bundang Hospital
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SeongNam, GyeongGi, Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
🇰🇷
Seoul, Korea, Republic of
National Cancer Center
🇰🇷
Goyang-si, Gyeonggi-do, Korea, Republic of
Daehang Hospital
🇰🇷
Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷
Seoul, Jongno-gu, Korea, Republic of