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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Gyeonggi-do
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Goyang, Gyeonggi-do, 대한민국, 410-769
- National Cancer Center Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: One dose
One dose prophylactic antibiotic
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preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Surgical site infection
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall infection
기간: Three weeks after surgery
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Overall infection including surgical site infection, pneumonia, urinary tract infection etc.
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Three weeks after surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jae Hwan Oh, Center for Colorectal Cancer, National Cancer Center Korea
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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