UMIN-CTR Clinical Trial

Public title

Multicenter Prospective Randomized Trial about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection in Digestive Surgery

Acronym

RCT about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection

Scientific Title

Multicenter Prospective Randomized Trial about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection in Digestive Surgery

Scientific Title:Acronym

RCT about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection

Region

Japan

Condition

Gastric cancer, Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

1) Compare rate of surgical site infection occurrence between use of absorbable sutures and silk sutures in peritoneal cavity in digestive surgery.
2) In cases with surgical site infection, compare duration of surgical site infection and hospital stay between use of absorbable sutures and silk sutures.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Rate of surgical site infection occurrence

Key secondary outcomes

1) Rate of surgical site infection occurrence by sites (superficial incision wound, deep incision wound, organ/cavity)
2) 1. Duration until healing of surgical site infection
2. Hospital stay after surgery

Study type

Interventional

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 considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Use of silk sutures in peritoneal cavity

Interventions/Control_2

Use of absorbable sutures in peritoneal cavity

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

1) Group 1: Open gastrectomy
Curative distal gastrectomy or total gastrectomy for patients with gastric cancer
Group 2: Open colectomy or rectal resection
Curative resection with D2 lymph nodes dissection for patients with colorectal cancer
2) Age ranged from 20 to 80 years old
3) Performance status 0-1
4) Preserved general condition;
1. WBC:3,000<=WBC<10,000 /microlitre
2. Neu:Neu>=1,500 /microlitre
3. Hb:Hb>=9.0 g/dL
4. Plt:Plt>=70,000 /microlitre
5. TB:TB<=1.5 mg/dL
6. AST:AST<=100 IU/L
7. ALT:ALT<=100 IU/L
8. Cr:Cr<=1.2 mg/dL
9. Alb:Alb>=2.8 g/dL
5) Provision of written informed consent

Key exclusion criteria

1) Emergency cases
2) Group 1: Laparoscopic surgery, partial resection, combined resection of other organ for gastric cancer
Group 2: Laparoscopic surgery, partial resection, resection with D0,1 lymph nodes dissection, Miles operation, Pelvic exenteration, Hartmann operation for colorectal cancer
3) Active infection
4) Pregnancy
5) ASA physical status 3<
6) Preoperative chemotherapy, radiotherapy, use of antibiotics within 2 weeks, use of immunosuppressive agent
7) Uncontrolled diabetes mellitus
8) Severe organ failure
9) Present stoma
10) Not eligible judged by doctor

Target sample size

540

Name of lead principal investigator

1st name
Middle name
Last name	Yoshihiko Maehara

Organization

Kyushu University,Graduate School of Medical Sciences

Division name

Department of Surgery and Science

Zip code

Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582

TEL

092-642-5466

Email

Name of contact person

1st name
Middle name
Last name	Yoshihiro Kakeji

Organization

Kyushu University,Graduate School of Medical Sciences

Division name

Department of Surgery and Science

Zip code

Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582

TEL

092-642-5466

Homepage URL

Email

kakeji@surg2.med.kyushu-u.ac.jp

Institute

Department of Surgery and Science,
Graduate School of Medical Sciences,
Kyushu University

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2008

Year

11

Month

06

Day

Date of IRB

Anticipated trial start date

2009

Year

01

Month

01

Day

Last follow-up date

2011

Year

02

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

12

Month

02

Day

Last modified on

2009

Year

10

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001858