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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030518
Receipt No. R000034839
Scientific Title When and how to remove prophylactic abdominal drains after elective liver resection: a retrospective observational study evaluating drain removal on the third and first postoperative day
Date of disclosure of the study information 2017/12/22
Last modified on 2020/06/23

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Basic information
Public title When and how to remove prophylactic abdominal drains after elective liver resection: a retrospective observational study evaluating drain removal on the third and first postoperative day
Acronym a retrospective observational study about early removal of drains after liver resection
Scientific Title When and how to remove prophylactic abdominal drains after elective liver resection: a retrospective observational study evaluating drain removal on the third and first postoperative day
Scientific Title:Acronym a retrospective observational study about early removal of drains after liver resection
Region
Japan

Condition
Condition Patients who underwent open liver resection at the University of Tokyo Hospital
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We have shortened the duration of drain placement in a step-by-step manner, from more than 7 days to 3 days, and 1 day. The objective of the present study is to evaluate whether we could reduce the length of the postoperative hospital stay and the incidence of drain infection without impairing safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The length of postoperative hospital stay
Key secondary outcomes Incidences of major complications such as drain infection, bile leakage, and percutaneous puncture for fluid collection. The proportion of patients with complications classified as grade III or above according to the Clavien-Dindo classification was also evaluated.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who underwent open liver resection at the University of Tokyo Hospital
Key exclusion criteria Patients with any of the following were excluded: a need for bilioenteric reconstruction; required resection of another organ (except cholecystectomy); other malignant disease outside the liver; an indocyanine green retention rate at 15 minutes 20% or more; and severe co-morbidity, such as renal dysfunction (estimated glomerular filtration rate of 20 mL per min per 1.73 m2 or less), cardiovascular disease (necessitating intervention or an ejection fraction of no more than 50 percent), or a respiratory disorder (vital capacity below 60 percent or forced expiratory volume in 1 s of less than 50 percent).
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Hasegawa
Organization The University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
TEL +81-3-3815-5411
Email kihase-tky@umin.ac.jp

Public contact
Name of contact person
1st name Akihiko
Middle name
Last name Ichida
Organization The University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
TEL +81-3-3815-5411
Homepage URL
Email ichida-tky@umin.ac.jp

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization This study was self-funded and not sponsored.
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 the Graduate School of Medicine and Faculty of Medicine, the University of Tokyo Research Ethics Committee
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel +81-3-3815-5411
Email ethics@m.u-tokyo.ac.jp

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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 22 Day

Related information
URL releasing protocol http://dx.doi.org/10.21037/atm.2020.04.04
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.21037/atm.2020.04.04
Number of participants that the trial has enrolled 323
Results
The median duration of the postoperative hospital stay was shorter in the POD 3 group than in the control group (P<0.0001). The incidence of drain infection was lower in the POD 3 group (1.2%) than in the control group (5.7%). Meanwhile, the incidences of bile leakage and complications were higher in the POD 1 group than in the POD 3 group. However, the incidences were almost the same when patients whose drains were actually removed on the predefined POD were compared.
Results date posted
2020 Year 06 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent open liver resection at the
University of Tokyo Hospital were included. Patients with
any of the following were excluded
a need for bilioenteric reconstruction
required resection of another organ except cholecystectomy
other malignant disease outside the liver
an age of less than 20 years or over 80 years
an indocyanine green retention rate at 15 min 20% or larger
severe co-morbidity
As we had just started laparoscopic liver resection when the present study was conducted, we decided to exclude these patients considering for safety.
Participant flow
Patients eligible for the present study were retrospectively analyzed.
Adverse events
None.
Outcome measures
Duration of drainage, Postoperative hospital stay, Infection of drains, Bile leakage defined by the ISGLS,Puncture of fluid collection, and Clavien-Dindo classification.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 11 Month 24 Day
Date of IRB
2017 Year 11 Month 24 Day
Anticipated trial start date
2017 Year 11 Month 24 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Conventionally, drains are removed from POD 7 to POD 14 at our institute (control group). Recently, we defined the criteria for the early removal of drains: (i) a drain-fluid bilirubin level of below 3 mg/dL; (ii) a drain discharge volume of less than 500 mL/day; and (iii) no macroscopic signs of blood or infection. In patients meeting the criteria, the drains were removed on POD 3 between January 2012 and February 2013 (POD 3 group) and on POD 1 between February and December 2013 (POD 1 group). The outcomes of these groups were retrospectively compared.

Management information
Registered date
2017 Year 12 Month 22 Day
Last modified on
2020 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034839

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/01/01 Upload_data.xlsx


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