UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004437
Receipt number 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 08:25:06

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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

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 or person

Institute

Department of Digestive Surgery, Nihon University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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