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| ID | Type | Description | Link |
|---|---|---|---|
| DP.04.03/D.XIV.10.1/301/2025 | Other Identifier | Health Research Ethic Committee M Djamil Hospital Padang Indonesia |
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| Name | Class |
|---|---|
| Dr. M Djamil Hospital, Padang | UNKNOWN |
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The goal of this clinical trial is to analyze the effect of Platelet Rich Plasma (PRP) Adjuvant To Type I/III Colagen Ratio, MMP-2 and MMP-9 in Pelvic Organ Prolapse Repair.
The main questions it aims to answer are:
Does the PRP Adjuvant affect type I/III Colagen Ratio, MMP-2 and MMP-9 in Pelvic Organ Prolapse Repair? Researchers will compare patient who undergo prolapse surgery with PRP adjuvant versus patient who undergo prolapse surgery without PRP adjuvant (placeebo)
Participants will:
Patient will undergo pelvic organ prolapse reconstrucion surgery and punch biopsy and injection of PRP will perform in anterior vaginal mucosa at Pubocervical area. The second biopsy will attempt in 8 weeks post operative. imunohistochemistry examination will be done to compare the type I/III Colagen Ratio, MMP-2 and MMP-9 before and after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | patient who receive POP surgery and PRP injection |
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| Group B | Experimental | patient who receive POP surgery and placebo injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POP surgery and PRP injection | Procedure | Patient who undergo POP surgery will receive PRP injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Type I/III collagen ratio | The evaluation of Type I/III collagen ratio are based on imunohistochemistry from punch biopsy in anterior vaginal mucosa that taken durung surgery and at 8 weeks post operative | From enrollment to the end of treatment at 8 weeks" |
| MMP-2 | MMP-2 was evaluate based on immunohistochemistry by using punch biopsy of anterior vaginal mucosa during and post surgery | From enrollment to the end of treatment at 8 weeks" |
| MMP-9 | MMP-9 are evaluate based on immunohistochemistry from anterior vaginal wall biopsy during and post operative | From enrollment to the end of treatment at 8 weeks" |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic floor muscle strength | Pelvic floor muscle strength was analyse using biofeedback | From enrollment to the end of treatment at 8 weeks" |
| Pelvic organ prolapse recurrency | Pelvic organ prolapse recurrency are evaluate based on POP Q system |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yulia Margaretta Sari Yulia Margaretta, Sari, MD | Contact | +6281363462158 | yulia_kino@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Yulia Margaretta Sari Yulia Margaretta, Sari, MD, MD | Biomedical Science Doctoral Programme Faculty of Medicine Andalas University/ Urogynecology Division Obstetrics and Gynecology Department M Djamil Hospital Padang Indonesia | Principal Investigator |
| Aisyah Elliyanti, Prof, PhD, MD | Biomedical Science Doctoral Programme Faculty of Medicine Andalas University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomedical Science Doctoral Programme Faculty of Medicine Andalas University/ Urogynecology Division Obstetrics and Gynecology Department M Djamil Hospital Padang | Recruiting | Padang | West Sumatera | Indonesia |
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| Label | URL |
|---|---|
| Research protocol | View source |
| Research Informed consent | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
informed consent should be taken from the patient to share the data
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Two group will receive different intervention One group will receive pelvic organ prolapse surgery and Platelet Rich Plasma injection One group will receive pelvic organ prolapse surgery and Placebo injection
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Only participants are masked in this study. Care provider can not be blind because the operator it self inject PRP , meanwhile PRP have different colour to placebo
| POP surgery and placebo injection | Procedure | patient who receive POP surgery and placebo injection |
|
| From enrollment to the end of treatment at 8 weeks" |
| Study Director |
| Bobby Indra, Utama, MD, PhD | Biomedical Science Doctoral Programme Faculty of Medicine Andalas University | Study Chair |
| Zelly Dia, Rofinda, MD, PhD | Biomedical Science Doctoral Programme Faculty of Medicine Andalas University | Study Chair |
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