UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037371 |
|---|---|
| Receipt number | R000042610 |
| Scientific Title | A multicenter study of efficacy and safety of Japanese-style laparoscopic sacrocolpopexy |
| Date of disclosure of the study information | 2019/07/16 |
| Last modified on | 2024/07/17 14:16:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multicenter study of efficacy and safety of Japanese-style laparoscopic sacrocolpopexy
Acronym
A multicenter study of efficacy and safety of Japanese-style laparoscopic sacrocolpopexy
Scientific Title
A multicenter study of efficacy and safety of Japanese-style laparoscopic sacrocolpopexy
Scientific Title:Acronym
A multicenter study of efficacy and safety of Japanese-style laparoscopic sacrocolpopexy
Region
| Japan |
Condition
Condition
Pelvic Organ Prolapse
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In a multicenter study, we will investigate the efficacy and safety of the Japanese-style LSC, which is an advanced version of the French LSC by the double mesh method in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Anatomical effectiveness with the POP-Q system.
2 Safety evaluation using Clavien-Dindo classification, Prosthesis / Graft Complication Classification Code.
3 Subjective effectiveness using P-QOL
Key secondary outcomes
1 Effects on lower urinary tract symptoms using IPSS
2 Effects on urinary incontinence using ICIQ-SF
3 Effects on OABSS overactive bladder
4 Effects on defecation function using PFDI
5 Effects on sexual function using PISQ-IR
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
Female
Key inclusion criteria
Among patients scheduled to receive treatment according to the Japanese-style LSC for pelvic organ prolapse, those who could obtain consent for the survey.
Key exclusion criteria
Patients who did not obtain consent for this study, patients who underwent concurrent surgery for co-morbidities.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Takeyama |
Organization
Daiichi Towakai Hospital
Division name
Femaleurology, urogynecologycenter
Zip code
569-0081
Address
2-17, Miyano-cho, Takatsuk city
TEL
072-671-1008
m-takeyama@me-medical.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kuwata |
Organization
Daiichi Towakai Hospital
Division name
Femaleurology, urogynecologycenter
Zip code
569-0081
Address
2-17, Miyano-cho, Takatsuk city
TEL
072-671-1008
Homepage URL
kuwatomo1108@gmail.com
Sponsor or person
Institute
Daiichi Towakai Hospital
Institute
Department
Personal name
Funding Source
Organization
Daiichi Towakai Hospital
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
Daiichi Towakai Hospital
Address
2-17, Miyano-cho, Takatsuk city
Tel
072-671-1008
kuwatomo1108@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
| 2019 | Year | 07 | Month | 16 | 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
262
Results
In anatomic recurrence, 24 patients (9.2%) were more than stage2 in the Pelvic Organ Prolapse Quantification (POP-Q) system at 3 years postoperatively, of which 4 (1.5%) and 20 (7.7%) were stage 3 and 2 respectively. No mesh-related complications were observed, and each questionnaire showed predominant improvement except for sexual and evacuation functions.
The Japanese-style LSC demonstrated superior anatomic and functional results, which we propose as a safe and effective procedure.
Results date posted
| 2024 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
We included 329 patients who were scheduled for LSC at each institution between November 2018 and May 2020 and who provided written consent after receiving a full explanation for their participation in the study. Of these, we evaluated 262 patients who were available for follow-up until the third postoperative year.
Adverse events
No mesh-related complications were observed. Adverse events included only two postoperative complications, a mild abdominal wall scar hernia, 0.4 percent, ClavienDindo classification V2.0, 1, and bowel obstruction 0.4 percent, ClavienDindo classification V2.0, 2, that resolved with conservative treatment.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 05 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 05 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 05 | Day |
Other
Other related information
We will monitor postoperative recurrence and complications, quality of life, etc.
Management information
Registered date
| 2019 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042610
