UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of subcutaneous drainage for hepatectomy: a randomized controlled trial
Acronym	Subcutaneous drainage for hepatectomy
Scientific Title	Efficacy of subcutaneous drainage for hepatectomy: a randomized controlled trial
Scientific Title:Acronym	Subcutaneous drainage for hepatectomy
Region	Japan

Condition
Condition	Primary liver cancer, metastatic liver cancer, biliary tract cancer, benign liver disease
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the preventive efficacy of subcutaneous drainage for surgical site infection on hepatectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Occurrence rate of surgical site wound infection and postoperative complication.
Key secondary outcomes	Hospital stay.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Suturing of wound with subcutaneous suction drainage.
Interventions/Control_2	Suturing of wound with no drainage.
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1) patients who will be planned hepatectomy. 2) Child-Pugh score of 7 or less 3) performance status 0-2 4) bone marrow function and hepatic/renal functions are well maintained a)White blood cell count: 2000-20000/mm3 b)Platelet count of 50000/mm3 or more c)Hemoglobin of 7.0g/dL or more d)Serum total bilirubin of 2.0mg/dL or less e)Prothronbin time of 50% or more f)Serum creatinine of 1.5mg/dL or less g)Blood urea nitrogen of 35mg/dL or less
Key exclusion criteria	1) Other chest-abdominal operation within 1 month on hepatectomy 2) History of myocardial infarction or unstable angina within 6 months prior to registration 3) Patient with interstitial pneumonia, pneumofibrosis, or severe lung emphysema 4) Patient who have allergy for material of drain. 5) Patient with psychiatric disorder or symptom 6) Pregnant patient or patient with possibility to be pregnant 7) Emargent hepatectomy 8) Patient with internal-organs resection of those other than liver.
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hisashi Nakayama
Organization	Nihon University Itabashi Hospital
Division name	Department of Digestive Surgery
Zip code
Address	30-1, Oyaguchikami-machi, Itabashi-ku, Tokyo
TEL	03-3972-8111(8214)
Email	nakayama.hisashi@nihon-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hisashi Nakayama
Organization	Nihon University Itabashi Hospital
Division name	Department of Digestive Surgery
Zip code
Address	30-1, Oyaguchikami-machi, Itabashi-ku, Tokyo
TEL	03-3972-8111(8214)
Homepage URL
Email	nakayama.hisashi@nihon-u.ac.jp

Sponsor
Institute	Department of Digestive Surgery, Nihon University School of Medicine
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
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Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	日本大学医学部附属板橋病院

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	J Hepatobiliary Pancreat Sci. 2014 Jul;21(7):509-17. doi: 10.1002/jhbp.93. Epub 2014 Feb 12. Subcutaneous drainage to prevent wound infection in liver resection: a randomized controlled trial. Nakayama H1, Takayama T, Okubo T, Higaki T, Midorikawa Y, Moriguchi M, Aramaki O, Yamazaki S.
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	Completed
Date of protocol fixation	2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date	2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2013 Year 12 Month 31 Day

Other

Other related information

RESULTS: We performed liver resections in 260 patients with hepatobiliary malignancies. Between the subcutaneous-drainage group (n = 131) and non-drainage group (n = 129), there were no significant differences in the operative variables. Wound infection occurred in 10 drainage group patients (8%) and 12 patients (9%) in the non-drainage group (P = 0.629); there was no significant difference in the probability of wound infection (P = 0.624). No significant differences were found between the groups for the hospital stay duration (P = 0.363), postoperative complications (P = 0.725) or medical expenses (P = 0.360). CONCLUSIONS: Subcutaneous drainage does not prevent wound infections in patients undergoing liver resection; therefore, its routine use is not justified.

Management information
Registered date	2010 Year 10 Month 25 Day
Last modified on	2014 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005300

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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