UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053250 |
|---|---|
| Receipt number | R000060769 |
| Scientific Title | Comparison of absorbable or permanent sutures for laparoscopic sacrocolpopexy: A randomized, prospective study |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/12/28 12:49:14 |
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Basic information
Public title
Comparison of absorbable or permanent sutures for laparoscopic sacrocolpopexy: A randomized, prospective study
Acronym
Comparison of absorbable or permanent sutures for laparoscopic sacrocolpopexy: A randomized, prospective study
Scientific Title
Comparison of absorbable or permanent sutures for laparoscopic sacrocolpopexy: A randomized, prospective study
Scientific Title:Acronym
Comparison of absorbable or permanent sutures for laparoscopic sacrocolpopexy: A randomized, prospective study
Region
| Japan |
Condition
Condition
pelvic organ prolapse
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to compare absorbable and non-absorbable sutures employed for mesh fixation in laparoscopic sacrocolpopexy (LSC) with concomitant supracervical hysterectomy (SCH) and investigate the composite failure rates.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Assessing composite failure within one year after using absorbable or permanent sutures during laparoscopic sacrocolpopexy combined with supracervical hysterectomy.
Key secondary outcomes
Mesh-related complications: suture or mesh exposure
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
delayed absorbable suture: polydioxanone
Interventions/Control_2
permanent suture: Tefdesser II
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients with pelvic organ prolapse who have surgical indications for laparoscopic sacrocolpopexy at the time of obtaining consent.
Key exclusion criteria
Patients who have not agreed to the consent form for surgery.
Switching from laparoscopic sacrocolpopexy to another surgical intervention.
Target sample size
184
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Sato |
Organization
Hokusuikai-Kinen Hospital
Division name
Department of urology
Zip code
310035
Address
3-2-1, Higashihara, Mito-city, Ibaraki-ken
TEL
0293033003
hirotakasato911@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Sato |
Organization
Hokusuikai-Kinen Hospital
Division name
Department of urology
Zip code
3100852
Address
3-2-1, Higashihara, Mito-city, Ibaraki-ken
TEL
0293033003
Homepage URL
hirotakasato911@yahoo.co.jp
Sponsor or person
Institute
Hokusuikai-Kinen hospital
Institute
Department
Personal name
Funding Source
Organization
Hokusuikai-Kinen hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokusuikai-Kinen Hospital
Address
3-2-1, Higashihara, Mito-city, Ibaraki-ken
Tel
0293033003
hirotakasato911@yahoo.co.jp
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
| 2024 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060769
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
