Clinical trial NCT01461525: Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial
Official title: Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: Low Rectal Cancer
Sphincter preservation
Abdominoperineal resection
Quality of life
Sexual function
Urinary function
Oncologic outcome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: National Cancer Center, Korea
name: Seoul National University Boramae Hospital
name: Hallym University Medical Center
name: Daehang Hospital
First posted: 2011-10-28
Enrollment: 342
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life outcome
timeFrame: 3 years
Secondary outcomes:
measure: Oncologic outcomes
timeFrame: 5 years
measure: Bladder function
timeFrame: 3 years
measure: Sexual function
timeFrame: 3 years
measure: Anal function
timeFrame: 3 years
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University College of Medicine
state: Gyeong-gi
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: SeongNam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: GyeongGi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Daehang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sung-Bum Kang, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang 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.