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Completed

NCT Number: NCT00508690

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

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

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyoto Katsura Hospital, Kyoto, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cefmetazole

Drug

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

kanamycin/metronidazole

Drug

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

Primary outcomes

  1. Incidence and classification of surgical site infection (SSI)

    Time frame: Within the first 30 days after surgery

Secondary outcomes

  1. Incidence of colitis, other infectious diseases and other postoperative complications.

    Time frame: Within the first 30 days after surgery

Sponsors and collaborators

Lead sponsor

Japan Multinational Trial Organization

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 30, 2007
Registry last updated
Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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