UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term QOL after laparoscopic intersphincteric resection for rectal malignany
Title of the study (Brief title)	Long-term QOL after Lap-ISR
Region	Japan

Condition
Condition	Rectal malignancies
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We investigate long-term quality of life (QOL) after laparoscopic intersphincteric resection (Lap-ISR) for rectal malignancies.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Long-term QOL after Lap-ISR
Key secondary outcomes	1. Long-term anal function after Lap-ISR 2. Long-term sexual function after Lap-ISR

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with rectal malignancies having undergone or will undergo an laparoscopic intersphincteric resection (Lap-ISR) at Shiga University of Medical Science hospital. Patients with rectal malignancies having undergone or will undergo an another operation such as open ISR, Lap-low anterior resection (LAR), open LAR, Lap-abdominoperineal resection (APR), and open APR are also included.
Key exclusion criteria	1. Patients who have difficulty in mutual understanding 2. Patients who cannot obtain a written informed consent.
Target sample size	100

Research contact person
Name of lead principal investigator	Hiromichi Sonoda
Organization	Shia University of Medical Science hospital
Division name	Digestive surgery
Address	Seta-tsukinowa-cho, Otsu, Shiga, Japan
TEL	+81-77-548-2238
Email	hirosono@belle.shiga-med.ac.jp

Public contact
Name of contact person	Hiromichi Sonoda
Organization	Shia University of Medical Science hospital
Division name	Digestive surgery
Address	Seta-tsukinowa-cho, Otsu, Shiga, Japan
TEL	+81-77-548-2238
Homepage URL
Email	hirosono@belle.shiga-med.ac.jp

Sponsor
Institute	Digestive surgery, Shia University of Medical Science
Institute
Department

Funding Source
Organization	None
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	2015 Year 06 Month 11 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 01 Month 14 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date
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	We investigate patient's QOL, anal function, and sexual function 6 months, 1 year, 3year, and 5year after surgery. Preoperative patient's QOL, anal function, and sexual function are also investigated.

Management information
Registered date	2015 Year 06 Month 11 Day
Last modified on	2017 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019673