Unique ID issued by UMIN | UMIN000019339 |
---|---|
Receipt number | R000022360 |
Scientific Title | Randomized controlled trial about the impact of oral antimicrobial prophylaxis on surgical site infection in laparoscopic colorectal surgery |
Date of disclosure of the study information | 2015/10/14 |
Last modified on | 2015/12/26 10:40:23 |
Randomized controlled trial about the impact of oral antimicrobial prophylaxis on surgical site infection in laparoscopic colorectal surgery
RCT of oral antimicrobial prophylaxis in laparoscopic colorectal surgery
Randomized controlled trial about the impact of oral antimicrobial prophylaxis on surgical site infection in laparoscopic colorectal surgery
RCT of oral antimicrobial prophylaxis in laparoscopic colorectal surgery
Japan |
Patients undergoing elective laparoscopic colorectal surgery
Gastrointestinal surgery |
Malignancy
NO
The aim of this prospective randomized controlled trial was to compare the efficacy of a combination of oral and intravenous antibiotics with intravenous antibiotics alone on the incidence of surgical site infection in patients undergoing elective laparoscopic colorectal surgery.
Bio-equivalence
Confirmatory
Phase III
The primary endpoint is the incidence of overall surgical site infection.
The secondary endpoints are the incidence of incisional site infections, organ/space infections, and enterocolitis.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Institution is not considered as adjustment factor.
2
Treatment
Medicine |
Patients assigned to the non-Oral group received 1 g of cefmetazole intravenously 30 min before the skin incision, then every 3 h during and immediately after the operation, stopping 24 h after completion of surgery.
Patients assigned to the Oral group received 750 mg of metronidazole and 1000 mg of kanamycin orally at 15:00 and 21:00 on the day before the surgery in addition to the same antibiotic regimen as the patients in the non-Oral group.
20 | years-old | <= |
Not applicable |
Male and Female
Patients undergoing elective laparoscopic colorectal surgery
Patients who inderstand the study and agre with written informed consent.
1)ileus
2)synchronous resection of other major organs
3)Patients who need antibiotics for other infectious diseases.
4)Patients who have undergone antibiotic administration 2 weeks before the surgery.
5)Patients with severe liver dysfunction
6)Patients with severe renal impairment
7)Patients with severe cardiac dysfunction
8)Patients with severe pulmonary dysfunction
9)Pregnancy or suspicion of pregnancy
10)lactating women
11)Patients who are considered unsuitable for the doctor
500
1st name | |
Middle name | |
Last name | Atsushi Ikeda |
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Department of Gastroenterological surgery
3-8-3, Ariake, Koto-ku, Tokyo,Japan
03-3520-0111
atsushi1120@gmail.com
1st name | |
Middle name | |
Last name | Konishi Tsuyoshi |
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Department of Gastroenterological surgery
3-8-3, Ariake, Koto-ku, Tokyo,Japan
03-3520-0111
tsuyoshi.konishi@jfcr.or.jp
Cancer Institute Hospital of Japanese Foundation for Cancer Research,
Department of Gastroenterological surgery
Cancer Institute Hospital of Japanese Foundation for Cancer Research,
Department of Gastroenterological surgery
Self funding
JAPAN
NO
がん研有明病院(東京都)
2015 | Year | 10 | Month | 14 | Day |
Unpublished
Completed
2013 | Year | 05 | Month | 08 | Day |
2013 | Year | 06 | Month | 07 | Day |
2015 | Year | 10 | Month | 14 | Day |
2015 | Year | 12 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022360