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CompletedNCT01220661Updated Dec 13, 2011

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

A Phase 2 interventional study of Cefotetan in Colorectal Surgery, sponsored by National Cancer Center, Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-12-13.

Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
312
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Colorectal Surgery

Keywords

  • Colorectal Surgery
  • Surgical Wound Infection
  • Laparoscopy
  • Anti-Bacterial Agents
03

In context

Lead sponsor

National Cancer Center, Korea is the lead sponsor of 193 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
312 participants (actual)

Study arms

  • Experimental
    One dose

    One dose prophylactic antibiotic

    Drug: Cefotetan

Interventions

  • DrugCefotetan

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

    Also known as: Yamatetan

06

What researchers measure

Primary outcomes

  1. Surgical site infection

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

    Time frame: Three weeks after surgery

Secondary outcomes

  1. Overall infection

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

    Time frame: Three weeks after surgery

07

Study locations

1 site
  • National Cancer Center Hospital
    Goyang, Gyeonggi-do 410-769, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01220661
Lead sponsor
National Cancer Center, Korea
Responsible party
Ji Won Park (M.D., National Cancer Center, Korea) — Principal investigator
First posted
Oct 14, 2010
Start date
Oct 2010
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Dec 13, 2011

Study contacts

Jae Hwan Oh
principal investigator · Center for Colorectal Cancer, National Cancer Center Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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