UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010281
Receipt number R000011963
Scientific Title A randomised controlled trial about clinical effect of closed subcutaneous drain against incisional surgical site infection in colorectal surgery
Date of disclosure of the study information 2013/03/19
Last modified on 2013/03/19 16:43:20

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Basic information

Public title

A randomised controlled trial about clinical effect of closed subcutaneous drain against incisional surgical site infection in colorectal surgery

Acronym

A RCT about clinical effect of closed subcutaneous drain against incisional surgical site infection

Scientific Title

A randomised controlled trial about clinical effect of closed subcutaneous drain against incisional surgical site infection in colorectal surgery

Scientific Title:Acronym

A RCT about clinical effect of closed subcutaneous drain against incisional surgical site infection

Region

Japan


Condition

Condition

Colorectal disorder

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To analyze whether closed subcutaneous drain reduce the incidence of incisional SSI in colorectal surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Incidence of incisional SSI

Key secondary outcomes

Hospital stay after surgery
cost effectiveness
the number of days of wound healing after infection
Incidence of seroma
Incidence of wound maceration
Incidence of wound dehiscence
Incidence of reoperation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Control group
Abdominal incision were closed with 1-Vicryl for the fascia and 4-0PDS subcuticular sutures for the skin

Interventions/Control_2

Trial group
Abdominal incision were closed with 1-Vicryl for the fascia and 4-0PDS subcuticular sutures for the skin.In traial group,the 15 Fr Blake drain was inserted between fascia and skin

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


Not applicable

Gender

Male and Female

Key inclusion criteria

colorectal surgery
Written informed consent

Key exclusion criteria

Appendectomy
Hernia repair
Laparoscopic operation without additional skin incision
Re-do operations before the end of wound healing of the primary operation
History of radiotherapy in lower abdomen Emergency operation

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Watanabe

Organization

Yokosuka Kyosai Hospital

Division name

Department of Surgery

Zip code


Address

1-16 Yonegahama street

TEL

046-822-2710

Email



Public contact

Name of contact person

1st name
Middle name
Last name Makoto Kawamoto

Organization

Yokosuka Kyosai Hospital

Division name

1-16 Yonegahama street

Zip code


Address


TEL

046-822-2710(ext.7718)

Homepage URL


Email



Sponsor or person

Institute

Yokosuka Kyosai Hospital

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

None

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

横須賀共済病院(神奈川県)/Yokosuka kyosai Hospital(Kanagawa)


Other administrative information

Date of disclosure of the study information

2013 Year 03 Month 19 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Open public recruiting

Date of protocol fixation

2012 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 03 Month 19 Day

Last modified on

2013 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011963


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name