infectious surgical site complications after oral antibiotic bowel preparation for minimally-invasive rectal cancer surgery
- Conditions
- Neoplasms
- Registration Number
- KCT0004822
- Lead Sponsor
- Korea University Ansan Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 438
1)age 20~75
2) pathologically confirmed rectal adenocarcinoma of which lower margin is located within 15cm from anal verge
3) radiologically confirmed non-metastatic rectal cancer (cTanyNantM0)
4) ECOG performance status 0-2
5) ASA = 3
6) A patient who understands this clinical trial and agrees to be enrolled
1) anticipated other organ resection
2) metastatic disease
3) one who have been treated for infections or have taken antibiotics within 2 weeks before surgery
4) severe major organ dysfunction (heart, lung, liver, kidney)
5) A patient who is taking steroid or immunosuppresants
6) inflammatory bowel disease
7) A patient who has undergone chemotherapy within 1 month due to malignant disease of other organ
8) decrease in white blood cell for various reasons
9)pregnant or lactating women
10)local resection of rectal cancer
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method surgical site infection rate during first 30 days
- Secondary Outcome Measures
Name Time Method overall complication;adverse event;C. difficile colitis;incisional SSI;organ/space SSI;anastomotic leakage rate