infectious surgical site complications after oral antibiotic bowel preparation for minimally-invasive rectal cancer surgery

infectious surgical site Complications after Oral antibiotic Bowel preparation for minimally-invasive Rectal cAncer surgery (COBRA) – multicenter prospective randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004822

Enrollment

438

Registered

2020-03-12

Start date

2020-03-06

Completion date

Unknown

Last updated

2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1. experimental group (A) - mechanical bowel preparation (PEG) + IV antibiotics 2. control group (B) - mechanical bowel preparation (PEG) + IV antibiotics + oral antibiotics (rifaximin + metr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
surgical site infection rate during first 30 days	—

Secondary

Measure	Time frame
overall complication;adverse event;C. difficile colitis;incisional SSI;organ/space SSI;anastomotic leakage rate	—

Countries

Korea, Republic of

Contacts

Public ContactWoong Bae Ji

Korea University Ansan Hospital

Outcome results