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OpenTrials
Completed

NCT Number: NCT01220661

Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery

In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.

It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough.

The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center Hospital

Goyang-si, Gyeonggi-do, 410-769, South Korea

About this study

In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.

One randomized controlled study reported that surgical site infection rates of three doses prophylactic antibiotics are lower than those of one dose in colorectal surgery (4.3 versus 14.2%). But, surgical site infection rates between one dose and three doses were not different in laparoscopic subgroup of this study (11 versus 11%)

It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough.

The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients have laparoscopic colorectal surgery for cancer at National Cancer Center
  • Patients should sign a written informed consent
  • Age between 18-80 years
  • Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
  • Adequate kidney function Creatinine ≤ 1.5 mg/dl
  • No remarkable evidence of heart dysfunction and lung dysfunction

Exclusion criteria

  • Patients undergo emergency surgery with multiple symptoms
  • Open colorectal surgery for cancer or conversion to an open procedure
  • Patients who undergo only ostomy surgery
  • Palliative surgery
  • Surgery combined with other organs
  • Patients on treatment with recurred cancer
  • Patients who have active bacterial infection and required parenteral antibiotics
  • Patients have an allergy to Cefoxitin
  • Other organ cancer history(except who had radical excision for skin cancer)
  • Presence of other serious disease
  • Mentally ill patients
  • Legally unable to participate in clinical trial
  • Lactating or pregnant women
  • Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
  • Not eligible to participate for other reasons by doctor's decision

Treatment and study plan

Cefotetan

Drug

preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)

Other names: Yamatetan

Primary outcomes

  1. Surgical site infection

    Time frame: Three weeks after surgery

    any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)

Secondary outcomes

  1. Overall infection

    Time frame: Three weeks after surgery

    Overall infection including surgical site infection, pneumonia, urinary tract infection etc.

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

Phase 2 Study of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2010
Registry last updated
Dec 13, 2011

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.

Published trials that share one or more normalized conditions with this study.