UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics
Title of the study (Brief title)	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	Hiroaki Hata
Organization	National Hospital Organization, Kyoto Medical Center
Division name	Surgery Division
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	Hiroaki Hata
Organization	National Hospital Organization, Kyoto Medical Center
Division name	Surgery Division
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2007 Year 05 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/26756752
Results
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/icdr_e/ctr_view.cgi?recptno=R000000935