Pelvic Organ Prolapse Vaginal Surgery, Platelet Rich Plasma Injection
Conditions
Keywords
Pelvic organ prolapse surgery, Platelet rich plasma injection, Type I/III collagen ratio, MMP-2, MMP-9, Randomized controlled trial
Brief summary
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.
Detailed description
1. Prepare tools and materials for the research. 2. Align perceptions with the research team to conduct well-guided interviews. 3. Patients who meet the inclusion and exclusion criteria will be given an explanation and a research information sheet and asked for consent to participate in the study. 4. Subjects who agree to participate in the study will then undergo a urogynecological medical record and gynecological physical examination, pelvic floor muscle strength, and POP Q. 5. Randomization of study subjects will be performed. 6. Participants are unaware of whether they would receive PRP therapy or a placebo. 7. The study subjects were hospitalized in preparation for surgery, in accordance with the regulations of the hospital where the study subjects were located. 8. PRP was prepared from the patient's own blood on the day of surgery. Blood was drawn no later than one hour before surgery. Twenty milliliters of blood was collected for processing into PRP. 9. Participant undergo pelvic organ prolapse surgery as a medically indicated treatment for pelvic organ prolapse. 10. Punch biopsies were performed on the anterior vaginal mucosa located in the Fascia Pubocervicalis area, 6 mm deep. The tissue was sent in a special medium to the Anatomical Pathology Laboratory of Dr. M. Djamil General Hospital. 11. PRP or placebo injections were administered based on a random number sequence determined by block randomization among subjects undergoing POP surgery in the Surgical Unit of the hospital where the study subjects were located. 12. The PRP preparation was placed in a 5 cc syringe. 13. The placebo preparation, containing NaCl solution, was placed in a 5 cc syringe. 14. The injection was performed by the POP surgery operator into the anterior vaginal wall to a depth of approximately 1-1.5 cm, estimating the location of the Fascia Pubocervicalis. 15. Further observation was conducted 8 weeks after surgery, involving punch biopsies of the anterior vaginal mucosa from three sites. These were then sent on special media to the Anatomical Pathology Laboratory of Dr. M. Djamil General Hospital for examination of the type I/III collagen ratio, MMP-2, and MMP-9.
Interventions
PROCEDUREPOP surgery and PRP injection
Patient who undergo POP surgery will receive PRP injection
PROCEDUREPOP surgery and placebo injection
patient who receive POP surgery and placebo injection
Sponsors
Andalas University
Dr. M Djamil Hospital, Padang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with second-degree or higher pelvic organ prolapse 2. Postmenopausal pelvic organ prolapse patients 3. Patients with pelvic organ prolapse who will undergo surgery 4. Willingness to participate in the study
Exclusion criteria
1. Patients with gynecological malignancies 2. Patients with a history of collagen disease 3. Patients with blood disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type I/III collagen ratio | From enrollment to the end of treatment at 8 weeks" | 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 |
| MMP-2 | From enrollment to the end of treatment at 8 weeks" | MMP-2 was evaluate based on immunohistochemistry by using punch biopsy of anterior vaginal mucosa during and post surgery |
| MMP-9 | From enrollment to the end of treatment at 8 weeks" | MMP-9 are evaluate based on immunohistochemistry from anterior vaginal wall biopsy during and post operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic floor muscle strength | From enrollment to the end of treatment at 8 weeks" | Pelvic floor muscle strength was analyse using biofeedback |
| Pelvic organ prolapse recurrency | From enrollment to the end of treatment at 8 weeks" | Pelvic organ prolapse recurrency are evaluate based on POP Q system |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORYulia 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
STUDY_DIRECTORAisyah Elliyanti, Prof, PhD, MD
Biomedical Science Doctoral Programme Faculty of Medicine Andalas University
STUDY_CHAIRBobby Indra, Utama, MD, PhD
Biomedical Science Doctoral Programme Faculty of Medicine Andalas University
STUDY_CHAIRZelly Dia, Rofinda, MD, PhD
Biomedical Science Doctoral Programme Faculty of Medicine Andalas University
Outcome results
None listed