UMIN-CTR Clinical Trial

Basic information
Public title	Colonoscopy -assisted percutaneous sigmoidopexy for the treatment of complete rectal prolapse
Acronym	CAPS for the treatment of complete rectal prolapse
Scientific Title	Colonoscopy -assisted percutaneous sigmoidopexy for the treatment of complete rectal prolapse
Scientific Title:Acronym	CAPS for the treatment of complete rectal prolapse
Region	Japan

Condition
Condition	complete rectal prolapse
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The efficacy and safety of colonoscopy -assisted percutaneous sigmoidopexy for the treatment of complete rectal prolapse
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	operative time
Key secondary outcomes	blood loss, complications, recurrence rate, and symptom improvement

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Colonoscopy-assisted percutaneous sigmoidopexy
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	consecutive participants diagnosed with complete rectal prolapse at the outpatient department of the International University of Health and Welfare Hospital.
Key exclusion criteria	Patients who do not undergo the treatment procedure after receiving an explanation of the details of the study are not included.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Junji Middle name Last name Takahashi
Organization	International University of Health and Welfare Hospital
Division name	Department of surgery
Zip code	3292763
Address	537-3, Iguchi, Nasushiobara City, Tochigi
TEL	+81287372221
Email	jtakahashi1127@gmail.com

Public contact
Name of contact person	1st name Junji Middle name Last name Takahashi
Organization	International University of Health and Welfare Hospital
Division name	Department of surgery
Zip code	3292763
Address	537-3, Iguchi, Nasushiobara City, Tochigi
TEL	+81287372221
Homepage URL
Email	jtakahashi1127@gmail.com

Sponsor
Institute	International University of Health and Welfare 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)

IRB Contact (For public release)
Organization	International University of Health and Welfare Hospital
Address	537-3, Iguchi, Nasushiobara City, Tochigi
Tel	+81287372221
Email	jtakahashi1127@gmail.com

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	2022 Year 10 Month 17 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	2016 Year 06 Month 01 Day
Date of IRB	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2036 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 10 Month 17 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056074