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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004437
Receipt No. R000005300
Scientific Title Efficacy of subcutaneous drainage for hepatectomy: a randomized controlled trial
Date of disclosure of the study information 2010/10/25
Last modified on 2014/12/01

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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
Last 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
1st 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
Tel
Email

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
Registered date File name

Research case data
Registered date File name

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