UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective randomized controlled trial comparing continuous suture with interrupted suture for primary dermis closure methods after colorectal cancer surgery.
Title of the study (Brief title)	Prospective randomized controlled trial comparing continuous suture with interrupted suture for primary dermis closure methods after colorectal cancer surgery.
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate cosmetic value of primary dermis closure method comparing continuous suture with interrupted suture after colorectal cancer surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	After six months of operation, we take a picture of wound scar and measure the size of wound scar blindly. This picture evaluated visual scale by three surgeons and three nurses.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	This study aimed to evaluate cosmetic value of primary dermis closure method comparing continuous suture with interrupted suture after colorectal cancer surgery.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Primary colorectal cancer patients over twenty years old. No evidence of metastasis patients. Procedure of operation is unnecessary. Patients that agree this study on document of informed consent.
Key exclusion criteria	Severe controlled diabetes patient and patients taken steroids. Patients that required emergency operation for perforation or bleeding of intestine.
Target sample size	210

Research contact person
Name of lead principal investigator	Katsuji Tokuhara
Organization	Kansai Medical University Hirakata Hospital
Division name	Department of Surgery
Address	2-3-1 Shinmachi, Hirakata
TEL	072-804-0101
Email

Public contact
Name of contact person	Katsuji Tokuhara
Organization	Kansai Medical University Hirakata Hospital
Division name	Department of Surgery
Address	2-3-1 Shinmachi, Hirakata
TEL	072-804-0101
Homepage URL
Email	tokuhark@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2009 Year 06 Month 23 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 06 Month 23 Day
Anticipated trial start date	2009 Year 06 Month 01 Day
Last follow-up date	2013 Year 03 Month 01 Day
Date of closure to data entry	2013 Year 11 Month 01 Day
Date trial data considered complete	2013 Year 12 Month 01 Day
Date analysis concluded	2014 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 06 Month 23 Day
Last modified on	2016 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002572