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

NCT01220661 | Completed Phase 2

• 1 other identifier: NCCCTS-10-485
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Surgery

Keywords

Colorectal Surgery; Surgical Wound Infection; Laparoscopy; Anti-Bacterial Agents

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

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

  Three weeks after surgery

Secondary Outcomes (1)

• Overall infection

  Three weeks after surgery

Study Arms (1)

One dose

EXPERIMENTAL

One dose prophylactic antibiotic

Drug: Cefotetan

Interventions

Cefotetan DRUG

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

Also known as: Yamatetan

One dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Hospital

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

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefotetan

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephamycins; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jae Hwan Oh

  Center for Colorectal Cancer, National Cancer Center Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 14, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 13, 2011

Record last verified: 2011-12

Locations

KR (1)