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UMIN-CTR Clinical Trial |
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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 |
Basic information | ||
Public title | Efficacy of subcutaneous drainage for hepatectomy: a randomized controlled
trial |
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Acronym | Subcutaneous drainage for hepatectomy | |
Scientific Title | Efficacy of subcutaneous drainage for hepatectomy: a randomized controlled
trial |
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Scientific Title:Acronym | Subcutaneous drainage for hepatectomy | |
Region |
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Condition | ||
Condition | Primary liver cancer, metastatic liver cancer, biliary tract cancer, benign liver disease | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Suturing of wound with subcutaneous suction drainage. | |
Interventions/Control_2 | Suturing of wound with no drainage. | |
Interventions/Control_3 | ||
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Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 250 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nihon University Itabashi Hospital
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Division name | Department of Digestive Surgery | ||||||
Zip code | |||||||
Address | 30-1, Oyaguchikami-machi, Itabashi-ku, Tokyo | ||||||
TEL | 03-3972-8111(8214) | ||||||
nakayama.hisashi@nihon-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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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 |
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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 |
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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 |
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Last modified on |
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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 |