Unique ID issued by UMIN | UMIN000004437 |
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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 |
Efficacy of subcutaneous drainage for hepatectomy: a randomized controlled
trial
Subcutaneous drainage for hepatectomy
Efficacy of subcutaneous drainage for hepatectomy: a randomized controlled
trial
Subcutaneous drainage for hepatectomy
Japan |
Primary liver cancer, metastatic liver cancer, biliary tract cancer, benign liver disease
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the preventive efficacy of subcutaneous drainage for surgical
site infection on hepatectomy.
Efficacy
Confirmatory
Pragmatic
Phase III
Occurrence rate of surgical site wound infection and postoperative complication.
Hospital stay.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Maneuver |
Suturing of wound with subcutaneous suction drainage.
Suturing of wound with no drainage.
20 | years-old | <= |
79 | years-old | >= |
Male and Female
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
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.
250
1st name | |
Middle name | |
Last name | Hisashi Nakayama |
Nihon University Itabashi Hospital
Department of Digestive Surgery
30-1, Oyaguchikami-machi, Itabashi-ku, Tokyo
03-3972-8111(8214)
nakayama.hisashi@nihon-u.ac.jp
1st name | |
Middle name | |
Last name | Hisashi Nakayama |
Nihon University Itabashi Hospital
Department of Digestive Surgery
30-1, Oyaguchikami-machi, Itabashi-ku, Tokyo
03-3972-8111(8214)
nakayama.hisashi@nihon-u.ac.jp
Department of Digestive Surgery, Nihon University School of Medicine
None
Self funding
NO
日本大学医学部附属板橋病院
2010 | Year | 10 | Month | 25 | Day |
Published
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.
Completed
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 04 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2013 | Year | 12 | Month | 31 | Day |
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.
2010 | Year | 10 | Month | 25 | Day |
2014 | Year | 12 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005300
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