The Effects of Platelet Rich Plasma Adjuvant to Type I/III Collagen Ratio, Matrix Metalloproteinase-2 and Matrix Metalloproteinase-9 in Pelvic Organ Prolapse Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Type I/III collagen ratio
研究概览
简要总结
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.
详细描述
- Prepare tools and materials for the research.
- Align perceptions with the research team to conduct well-guided interviews.
- 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.
- 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.
- Randomization of study subjects will be performed.
- Participants are unaware of whether they would receive PRP therapy or a placebo.
- The study subjects were hospitalized in preparation for surgery, in accordance with the regulations of the hospital where the study subjects were located.
- 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.
- Participant undergo pelvic organ prolapse surgery as a medically indicated treatment for pelvic organ prolapse.
- 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.
- 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.
- The PRP preparation was placed in a 5 cc syringe.
- The placebo preparation, containing NaCl solution, was placed in a 5 cc syringe.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with second-degree or higher pelvic organ prolapse
- •Postmenopausal pelvic organ prolapse patients
- •Patients with pelvic organ prolapse who will undergo surgery
- •Willingness to participate in the study
排除标准
- •Patients with gynecological malignancies
- •Patients with a history of collagen disease
- •Patients with blood disorders
研究组 & 干预措施
Group B
patient who receive POP surgery and placebo injection
干预措施: POP surgery and placebo injection (Procedure)
Group A
patient who receive POP surgery and PRP injection
干预措施: POP surgery and PRP injection (Procedure)
结局指标
主要结局
Type I/III collagen ratio
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Pelvic floor muscle strength(From enrollment to the end of treatment at 8 weeks")
- Pelvic organ prolapse recurrency(From enrollment to the end of treatment at 8 weeks")
研究者
Yulia Margaretta Sari
MD
Andalas University