The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery After Robot Assisted Radical Prostatectomy: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Recovery rate of urinary incontinence
研究概览
简要总结
This study is a single center, single blind, prospective randomized controlled trial. Patients undergoing robot assisted laparoscopic radical prostatectomy for prostate cancer were randomly divided into 1:1:1 groups, using lateral reconstruction, posterior reconstruction, or no reconstruction. Patients were followed up regularly after surgery and clinical data were collected, including daily use of urine pads, ICIQ-SF score, 24-hour urine leakage, I-QoL score, etc., to evaluate the improvement effect of lateral reconstruction on urinary control and the difference in effect between lateral reconstruction and posterior reconstruction, thereby improving the quality of life of prostate cancer patients after surgery.
详细描述
This study is a single center, single blind, prospective randomized controlled trial. Collect baseline data from enrolled patients Materials were randomly divided into experimental group A (lateral reconstruction group), experimental group B (posterior reconstruction group), and control group (non reconstruction group) in a 1:1:1 ratio using a computer-generated random number sequence.
In the control group (non reconstruction group), no lateral or posterior reconstruction was performed after RARP surgery.
In experimental group A (lateral reconstruction group), lateral reconstruction was performed after RARP surgery, in which the levator ani muscle was sutured to the prostatic collateral ligament and fascia to strengthen the lateral posterior support structure.
In experimental group B (post reconstruction group), post reconstruction was performed after RARP surgery.
This study used blinding on patients to avoid subjective factors affecting the results of whether reconstruction was performed or not.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with prostate cancer and preoperative clinical stage of cT2~T3aN0M0
- •Complies with the indications for RARP surgery
排除标准
- •History of urinary incontinence or urethral stricture
- •Previous prostate related surgical treatment
- •Contraindications for RARP surgery
- •The patient or their family members refuse to participate
结局指标
主要结局
Recovery rate of urinary incontinence
时间窗: 1,3,6,9,12 months after operation
Urinary incontinence recovery is defined as using 0 urinary pads per day
次要结局
- Perioperative and postoperative complications(1,3,6,9,12 months after operation)
- The International Consultation on Incontinence Questionnaire Short-form(ICIQ-SF) Score(1,3,6,9,12 months after operation)
- Incontinence Quality of Life Questionnaire(I-QOL) Score(1,3,6,9,12 months after operation)
- Duration of operation(immediately after operation)
- Prostate-specific antigen(1,3,6,9,12 months after operation)
研究者
GONG Kan
Chief physician
Peking University First Hospital