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Trial Title:
Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial
NCT ID:
NCT01461525
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Low Rectal Cancer
Sphincter preservation
Abdominoperineal resection
Quality of life
Sexual function
Urinary function
Oncologic outcome
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Abdominoperineal resection
Description:
After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with
sphincter sacrifice and permanent colostomy.
Arm group label:
Abdominoperineal Resection
Other name:
APR
Other name:
Miles' operation
Intervention type:
Procedure
Intervention name:
Sphincter preservation surgery
Description:
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
Arm group label:
Sphincter preservation surgery
Other name:
SPS
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.
Criteria for 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hallym University College of Medicine
Address:
City:
Anyang
Zip:
431-070
Country:
Korea, Republic of
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si
Zip:
410-769
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
SeongNam
Zip:
463-707
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
110-744
Country:
Korea, Republic of
Facility:
Name:
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Address:
City:
Seoul
Zip:
156-707
Country:
Korea, Republic of
Facility:
Name:
Daehang Hospital
Address:
City:
Seoul
Zip:
481-10
Country:
Korea, Republic of
Start date:
October 2011
Completion date:
September 2021
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Collaborator:
Agency:
Seoul National University Bundang Hospital
Agency class:
Other
Collaborator:
Agency:
National Cancer Center, Korea
Agency class:
Other
Collaborator:
Agency:
Seoul National University Boramae Hospital
Agency class:
Other
Collaborator:
Agency:
Hallym University Medical Center
Agency class:
Other
Collaborator:
Agency:
Daehang Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01461525
