UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017872 |
|---|---|
| Receipt number | R000019673 |
| Scientific Title | Long-term QOL after laparoscopic intersphincteric resection for rectal malignany |
| Date of disclosure of the study information | 2015/06/11 |
| Last modified on | 2017/06/12 21:19:21 |
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Basic information
Public title
Long-term QOL after laparoscopic intersphincteric resection for rectal malignany
Acronym
Long-term QOL after Lap-ISR
Scientific Title
Long-term QOL after laparoscopic intersphincteric resection for rectal malignany
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiromichi Sonoda |
Organization
Shia University of Medical Science hospital
Division name
Digestive surgery
Zip code
Address
Seta-tsukinowa-cho, Otsu, Shiga, Japan
TEL
+81-77-548-2238
hirosono@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Sonoda |
Organization
Shia University of Medical Science hospital
Division name
Digestive surgery
Zip code
Address
Seta-tsukinowa-cho, Otsu, Shiga, Japan
TEL
+81-77-548-2238
Homepage URL
hirosono@belle.shiga-med.ac.jp
Sponsor or person
Institute
Digestive surgery, Shia University of Medical Science
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 14 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019673
