Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
Phase 2 Study 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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Gyeonggi-do
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Goyang, Gyeonggi-do, Korea, republiek van, 410-769
- National Cancer Center Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: One dose
One dose prophylactic antibiotic
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preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Surgical site infection
Tijdsspanne: Three weeks after surgery
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any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)
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Three weeks after surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall infection
Tijdsspanne: Three weeks after surgery
|
Overall infection including surgical site infection, pneumonia, urinary tract infection etc.
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Three weeks after surgery
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jae Hwan Oh, Center for Colorectal Cancer, National Cancer Center Korea
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NCCCTS-10-485
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