Rectal Cancer
Conditions
Keywords
Low Rectal Cancer, Sphincter preservation, Abdominoperineal resection, Quality of life, Sexual function, Urinary function, Oncologic outcome
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.
Interventions
PROCEDUREAbdominoperineal resection
After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.
PROCEDURESphincter 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
Sponsors
Seoul National University Bundang Hospital
National Cancer Center, Korea
Seoul National University Boramae Hospital
Hallym University Medical Center
Daehang Hospital
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life outcome | 3 years | Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
South Korea
Outcome results
None listed