UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized clinical trial of temporary ostomy reversal comparing purse-string approximation and primary closure with a drain
Title of the study (Brief title)	Randomized clinical trial of temporary ostomy reversal comparing purse-string approximation and primary closure with a drain
Region	Japan

Condition
Condition	Patients with colostomy or ileostomy
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Influence of skin closure techniques on their advantages, defects and complications after stoma reversal surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The healing rate of the wound
Key secondary outcomes	Infection rate of the wound

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Closed wound
Interventions/Control_2	Open wound
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with colostomy or ileostomy
Key exclusion criteria	None
Target sample size	126

Research contact person
Name of lead principal investigator	Hideyuki Ishida
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Digestive Tract and General Surgery
Address	1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL	049-228-3619
Email	05hishi@saitama-med.ac.jp

Public contact
Name of contact person	Keiichiro Ishibashi
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Digestive Tract and General Surgery
Address	1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL	049-228-3619
Homepage URL
Email	k_ishi@saitama-med.ac.jp

Sponsor
Institute	Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	2018 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 03 Month 09 Day
Anticipated trial start date	2007 Year 04 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 01 Month 15 Day
Date analysis concluded	2018 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 11 Day
Last modified on	2018 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035138