UMIN-CTR Clinical Trial

Public title

Randomized controlled trial about the impact of oral antimicrobial prophylaxis on surgical site infection in laparoscopic colorectal surgery

Acronym

RCT of oral antimicrobial prophylaxis in laparoscopic colorectal surgery

Scientific Title

Randomized controlled trial about the impact of oral antimicrobial prophylaxis on surgical site infection in laparoscopic colorectal surgery

Scientific Title:Acronym

RCT of oral antimicrobial prophylaxis in laparoscopic colorectal surgery

Region

Japan

Condition

Patients undergoing elective laparoscopic colorectal surgery

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

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.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

The primary endpoint is the incidence of overall surgical site infection.

Key secondary outcomes

The secondary endpoints are the incidence of incisional site infections, organ/space infections, and enterocolitis.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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.

Interventions/Control_2

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.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing elective laparoscopic colorectal surgery
Patients who inderstand the study and agre with written informed consent.

Key exclusion criteria

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

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Atsushi Ikeda

Organization

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Division name

Department of Gastroenterological surgery

Zip code

Address

3-8-3, Ariake, Koto-ku, Tokyo,Japan

TEL

03-3520-0111

Email

atsushi1120@gmail.com

Name of contact person

1st name
Middle name
Last name	Konishi Tsuyoshi

Organization

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Division name

Department of Gastroenterological surgery

Zip code

Address

3-8-3, Ariake, Koto-ku, Tokyo,Japan

TEL

03-3520-0111

Homepage URL

Email

tsuyoshi.konishi@jfcr.or.jp

Institute

Cancer Institute Hospital of Japanese Foundation for Cancer Research,
Department of Gastroenterological surgery

Institute

Department

Personal name

Organization

Cancer Institute Hospital of Japanese Foundation for Cancer Research,
Department of Gastroenterological surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

がん研有明病院（東京都）

Date of disclosure of the study information

2015

Year

10

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

05

Month

08

Day

Date of IRB

Anticipated trial start date

2013

Year

06

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

14

Day

Last modified on

2015

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022360