Trial | NCT00508690  Report issue

Title

Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    584
The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.
The use of antibiotic prophylaxis in patients who undergo elective colorectal surgery is now accepted universally. But the rout of administration should be systematic, oral, or both is controversial. Furthermore, although many trails have been performed, no trial limited to laparoscopic surgery is performed. We compare 2 approaches - oral and systemic versus systemic antibiotic prophylaxis - in limited to elective laparoscopic colorectal surgery.
Study Started
Sep 30
2007
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Last Update
Sep 19
2012
Estimate

Drug cefmetazole

Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

Drug kanamycin/metronidazole

2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

IV Active Comparator

Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

Oral/IV Active Comparator

2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

Criteria 

Inclusion Criteria:

Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection

Exclusion Criteria:

ECOG Performance Status >=2
Age<20
Any organ dysfunction
Ileus
Preoperative infectious disease
Antibiotic administration before surgery
Steroid administration before surgery
Neo-adjuvant radiation and/or chemo therapy
Severe diabetes mellitus
Pregnancy/lactational woman
Severe allergy
No Results Posted