UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058270 |
|---|---|
| Receipt number | R000065902 |
| Scientific Title | Influence of mesh modification and timing of imaging on 3D-CT visualization after laparoscopic sacrocolpopexy |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/06/25 11:40:08 |
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Basic information
Public title
Influence of mesh modification on 3D-CT visualization after laparoscopic sacrocolpopexy
Acronym
Influence of mesh modification on 3D-CT visualization after laparoscopic sacrocolpopexy
Scientific Title
Influence of mesh modification and timing of imaging on 3D-CT visualization after laparoscopic sacrocolpopexy
Scientific Title:Acronym
Influence of mesh modification and timing of imaging on 3D-CT visualization after laparoscopic sacrocolpopexy
Region
| Japan |
Condition
Condition
pelvic organ prolapse
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether processing of polytetrafluoroethylene (PTFE) mesh used in laparoscopic sacrocolpopexy for pelvic organ prolapse improves its visualization on CT scans and whether the timing of imaging affects the visibility.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CT scores for mesh visualization at 3 days and 6 weeks after laparoscopic sacrocolpopexy
Key secondary outcomes
Assessment of safety, including the presence of mesh-related complications, up to 3 years after laparoscopic sacrocolpopexy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
A modified PTFE mesh was used, in which the edges of the body portion were folded approximately 5 mm and double-layered by suturing with PTFE thread, for use in standard laparoscopic sacrocolpopexy.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1. Patients with pelvic organ prolapse who wish to undergo surgical treatment using mesh.
2. Patients who have received a full explanation of the study and provided written informed consent.
3. Patients with an ECOG Performance Status of 0.
4. Patients who are eligible for general anesthesia and laparoscopic surgery.
Key exclusion criteria
1. Patients aged under 50 or over 80 at the time of consent.
2. Patients with suspected malignancy based on preoperative evaluation.
3. Patients judged to have impaired decision-making capacity.
4. Patients in whom mesh fixation is considered difficult based on pelvic examination or imaging findings.
5. Patients with a history of severe intra-abdominal adhesions or other conditions making laparoscopic surgery difficult.
6. Patients with severe glaucoma.
7. Patients with poorly controlled diabetes mellitus.
8. Any other patients deemed unsuitable for participation in this study or for undergoing the surgical procedure, as judged by the investigators.
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Miwa |
Organization
Japanese Red Cross Gifu Hospital
Division name
Urogynecology Center
Zip code
5008175
Address
3-36, Iwakura-cho, Gifu-shi, Gifu 500-8175, Japan
TEL
058-231-2266
shokkadelica@hotmail.com
Public contact
Name of contact person
| 1st name | Akane |
| Middle name | |
| Last name | Yamaguchi |
Organization
University of Tsukuba hospital
Division name
Urology
Zip code
3058576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
+81-29-853-3900
Homepage URL
ayamaguchi-aic@umin.ac.jp
Sponsor or person
Institute
Japanese Red Cross Gifu Hospital
Institute
Department
Personal name
Funding Source
Organization
no cost
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
Japanese Red Cross Gifu Hospital
Address
3-36, Iwakura-cho, Gifu-shi, Gifu 500-8175, Japan
Tel
058-231-2266
ayamaguchi-aic@umin.ac.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
日本赤十字社 岐阜赤十字病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 25 | 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
19
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was prospectively designed and received ethical approval prior to initiation. However, registration in the UMIN system was performed retrospectively, after the completion of the primary outcome. The secondary outcome (safety assessment at 3 years postoperatively) is still ongoing.
Management information
Registered date
| 2025 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065902
