UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of pelvic drain after rectal resection for rectal cancer
Title of the study (Brief title)	Is pelvic drain useful after rectal resection?
Region	Japan

Condition
Condition	rectal tumor
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the importance of pelvic drain after rectal resection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of pelvic sepsis
Key secondary outcomes	Asseeement of pain vy using VAS scale

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients after rectal resection with anastomosis
Key exclusion criteria	Patients without anastomosis
Target sample size	100

Research contact person
Name of lead principal investigator	Kenji Matsuda
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera Wakayama
TEL	073-441-0613
Email	kmatsuda@wakayama-med.ac.jp

Public contact
Name of contact person	Kenji Matsuda
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera Wakayama
TEL	073-441-0613
Homepage URL
Email	kmatsuda@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 02 Month 09 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 07 Month 20 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	None

Management information
Registered date	2017 Year 02 Month 09 Day
Last modified on	2017 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029960