UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

This study was self-funded and not sponsored.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京大学医学部附属病院(東京都)

Date of disclosure of the study information

2017

Year

12

Month

22

Day

URL releasing protocol

http://dx.doi.org/10.21037/atm.2020.04.04

Publication of results

Published

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

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 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.

Registered date

2017

Year

12

Month

22

Day

Last modified on

2020

Year

06

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034839