Nationwide Multicenter Randomized Prospective Study to Compare Laparoscopic Sacral Colpopexy and Modified Total Pelvic Floor Reconstructive Surgery With Mesh for Apical Prolapse Stage III-IV
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- anatomical improvement according to POP-Q score
研究概览
简要总结
Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. The primary treatment is surgery. Sacral Colpopexy is the gold standard procedure. Now it could be done laparoscopically. Modified total pelvic floor reconstructive surgery with mesh is developed in China for Asian Women.
This study is designed to determine the effectiveness and safety of Modified total pelvic floor reconstructive surgery with mesh compared with laparoscopic Sacral Colpopexy for the treatment of uterine or vault prolapse Stage III-IV.
Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.
详细描述
Pelvic organ prolapse is a common problem. The high rate of failure has led to an increasing use of synthetic grafts to augment vaginal repair procedures to obtain more durable results. In 2005, the investigators began to perform modified pelvic floor reconstruction surgery with mesh. The nation-wide multicenter prospective clinical trial data showed that it was safe, efficient and cost-effective. No severe intraoperative complications were recorded and the recurrence rate after 1 year follow-up was 8.1%. Quality of life improved significantly from the baseline, while the sexual function did not change.
Sacral colpopexy has long been regarded as the gold standard. Laparoscopic sacral colpopexy could offer durable result and low morbidity compared with open procedure.
In clinical practice, many women have symptomatic POP-Q Stage III-IV uterine or vault prolapse, which requires surgical correction. The aim of this multicenter, prospective and randomized study is to evaluate the effectiveness and safety of these two procedures in the treatment of symptomatic apical prolapse Stage III-IV in China.
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
- None
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Candidates with symptomatic uterine or vault prolapse of Stage III-IV, suitable for surgical repair.
- •Age from 55-65 years old.
- •Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.
排除标准
- •Patients who could not tolerate laparoscopic surgery.
- •Previous repair of pelvic organ prolapse involving insertion of mesh.
- •Experimental drug or experimental medical device within 3 months prior to the planned procedure.
- •Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
- •Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
- •History of chemotherapy or pelvic radiation therapy. Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spinal cord injury or trauma).
- •Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
- •Nursing or pregnant or intends future pregnancy.
- •Chronic cough not well-controlled.
- •In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
结局指标
主要结局
anatomical improvement according to POP-Q score
时间窗: 6 months
Anatomical improvement according to POP-Q Score
时间窗: 3 years
次要结局
- Hospital data:operative time(At discharge, an expected average of 5 days after operation.)
- Change from baseline in PFIQ-7 scores.(6 months, 1 year, 2 year, 3 year)
- Presence/absence of complications (composite score).(up to 6 weeks)
- Change from baseline in PFDI-21 scores.(6 months, 1 year, 2 year, 3 year)
- Subject global impression assessed on a 5 point Likert scale(6 months, 1 year, 2 year, 3 year)
- Presence/absence of complications (composite score)(up to 3 years)
- hospital data: postoperative morbidity(At discharge, an expected average of 5 days after operation.)
- In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)(6 months, 1 year, 2 year, 3 year)
- hospital data: estimated blood loss(At discharge, an expected average of 5 days after operation.)
- hospital data: time to recovery(At discharge, an expected average of 5 days after operation.)
- hospital data:length of stay(At discharge, an expected average of 5 days after operation.)