UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000776
Receipt No. R000000935
Scientific Title Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics
Date of disclosure of the study information 2007/08/01
Last modified on 2017/08/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics
Acronym Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics
Scientific Title Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics
Scientific Title:Acronym Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics
Region
Japan

Condition
Condition Colorectal tumor with planned elective laparoscopic resection
Classification by specialty
Infectious disease Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine optimal prophylactic antibiotic administration method in elective laparoscopic colorectal surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Incidence and classification of surgical site infection (SSI)
Key secondary outcomes Incidence of colitis, other infectious diseases and other postoperative complications.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
Interventions/Control_2 2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection
Key exclusion criteria 1) ECOG Performance Status >=2
2) Age<20
3) Any organ dysfunction
4) Ileus
5) Preoperative infectious disease
6) Antibiotic administration before surgery
7) Steroid administration before surgery
8) Neo-adjuvant radiation and/or chemo therapy
9) Diabetes mellitus
10) Pregnancy/lactational woman
11) Severe allergy
Target sample size 580

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Hata
Organization National Hospital Organization, Kyoto Medical Center
Division name Surgery Division
Zip code
Address 1-1, Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL 075-641-9161
Email hhata-kyt@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Hata
Organization National Hospital Organization, Kyoto Medical Center
Division name Surgery Division
Zip code
Address 1-1, Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL 075-641-9161
Homepage URL
Email hhata@kyotolan.hosp.go.jp

Sponsor
Institute The Japan-Multinational Trial Organization(JMTO)
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00508690
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/26756752
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

Progress
Recruitment status Main results already published
Date of protocol fixation
2007 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
2011 Year 12 Month 31 Day
Date of closure to data entry
2012 Year 04 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded
2013 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2007 Year 07 Month 26 Day
Last modified on
2017 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000935

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.