Know Cancer

or
forgot password

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


Phase 3
20 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence and classification of surgical site infection (SSI)

Outcome Time Frame:

Within the first 30 days after surgery

Safety Issue:

No

Principal Investigator

Hiroaki Hata, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Hospital Organization Kyoto Medical Center

Authority:

Japan: Institutional Review Board

Study ID:

JMTO PREV07-01

NCT ID:

NCT00508690

Start Date:

September 2007

Completion Date:

December 2011

Related Keywords:

  • Colorectal Neoplasms
  • Antibiotic Prophylaxis
  • Colorectal Surgery
  • Laparoscopy
  • Neoplasms
  • Colorectal Neoplasms

Name

Location