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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00508690

Enrollment

584

Registered

2007-07-30

Start date

2007-09-30

Completion date

2011-12-31

Last updated

2012-09-19

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

Conditions

Colorectal Neoplasms

Keywords

Antibiotic Prophylaxis, Colorectal Surgery, Laparoscopy

Brief summary

The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.

Detailed description

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.

Interventions

DRUGcefmetazole

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

DRUGkanamycin/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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence and classification of surgical site infection (SSI)	Within the first 30 days after surgery

Secondary

Measure	Time frame
Incidence of colitis, other infectious diseases and other postoperative complications.	Within the first 30 days after surgery

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026