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

Rectal Cancer Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01461525
• Other study ID #: APR-SPS trial
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2011
• Est. completion date: September 2021

Study information

• Verified date: October 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 342
• Est. completion date: September 2021
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Abdominoperineal resection
After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.
• Sphincter preservation surgery
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

Locations

Country	Name	City	State
Korea, Republic of	Hallym University College of Medicine	Anyang	Gyeong-gi
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	SeongNam	GyeongGi
Korea, Republic of	Daehang Hospital	Seoul
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (6)

Lead Sponsor	Collaborator
Seoul National University Hospital	Daehang Hospital, Hallym University Medical Center, National Cancer Center, Korea, Seoul National University Boramae Hospital, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life outcome	Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).	3 years
Secondary	Oncologic outcomes	Oncologic outcomes (recurrence, survival)	5 years
Secondary	Bladder function	Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months).	3 years
Secondary	Sexual function	Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).	3 years
Secondary	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