Comparison of therapeutic effect by number of access ports in laparoscopic surgery for colorectal cancer: Single-incision vs. Multi-port laparoscopic colectomy study (SIMPL study) (randomized phase II comparison study)
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000007220
- Lead Sponsor
- Yokohama City University Medical Center
- Brief Summary
SILC is not superior to MPLC. 1.Even though the results of the 5-year OS and RFS in this trial were exploratory and underpowered, there were no statistically significant differences between the SILC and MPC arms. SILC may be an acceptable treatment option for select patients with colon cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
1) Severe hypersensitivity 2) Multiple cancer (Simultaneous or metachronous multiple cancer which disease-free interval is five years or less. However, a lesion of carcinoma in situ and intramucosal carcinoma are allowed.) 3) Active infectious disease 4) The past history of the mental disease and/or the central nervous system damage that becomes a clinical problem 5) Pregnant woman, lactating woman and woman who has possibility of pregnancy (intention). 6) Severe concomitant disease (Cardiorespiratory dysfunction, renal failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes melitus, liver cirrhosis and chronic hepatitis A and C, etc) 7) The past history of the organ transplantation 8) Preoperative treatment (chemotherapy, radiation therapy, and hormonal therapy, etc.) for colorectal cancer 9) Patient who judged that examination responsibility doctor is improper as subject of clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence ratio of adverse event within postoperative one month
- Secondary Outcome Measures
Name Time Method Health related QOL score and patient satisfaction related to incised wound at the time of postoperative one month Short-term outcomes including operative time, amount of blood loss, postoperative stay and amount of analgesic use Long-term outcomes including 5-year overall survival and relapse-free survival