Vaginal Packing After Laparoscopic Sacrocolpopexy; Patient Pain and Satisfaction in Short Follow-up and Surgery Outcome and Complications in One Year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 253
- 试验地点
- 2
- 主要终点
- Prolapse recurrence
研究概览
简要总结
Vaginal packing is used routinely following vaginal reconstructive surgery, however, no recommendation regarding vaginal packing after laparoscopic sacrocolpopexy exists. Despite little data to support the practice, purported benefits better positioning and fixation of the mesh, improving incorporation of the mesh by its fixation and reduced blood loss. Patients often complain of discomfort associated with the packing or its removal. The aim of this randomized controlled is to compare the subjective impressions of pain and bother in women undergoing laparoscopic sacrocolpopexy treated with and without packing. The investigators also aim to assess differences in postoperative bacteriuria, urine retention and hemoglobin levels on day 5 after the surgery and surgery outcome and complications at one year after the surgery in those with and without packing.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Laparoscopic sacrocolpopexy without a suburethral sling
- •Pelvic organ prolapse stage > 2
- •Speak and read Czech
- •Can to understand the informed consent
排除标准
- •Any other surgery than sacrocolpopexy
- •Concurrent hysterectomy or opening of the vagina during the surgery.
- •Vaginal, uterine, cervical or ovarian malignancy
- •Clotting disorder, taking anticoagulation
- •Having intraoperative blood loss greater than 500 ml
结局指标
主要结局
Prolapse recurrence
时间窗: 1 year after the surgery
Pelvic Organ Prolapse Quantification System (POP-Q) classification - the most descending compartment \>-1cm from hymen
Satisfaction with the overall postoperative course assessed using VAS
时间窗: Postoperative day 5
VAS
Surgery related complications
时间窗: From the surgery until 1 year after the surgery
According to the International Continence Society / International UroGynecology Association Joint Terminology and Classification Report of the complications related directly to the insertion of prostheses (meshes, implants, tapes) \& grafts in female pelvic floor surgery
Postoperative pain assessed using VAS
时间窗: The first post-operative day before extraction of the packing
Visual analog scale (VAS)
Postoperative pain assessed using the McGill Questionnaire
时间窗: The first post-operative day before extraction of the packing
McGill Questionnaire
次要结局
- Positive urine culture(Postoperative day 5)
- Number of analgesics used(From the end of the surgery until the first postoperative day)
- Satisfaction with surgery assessed using VAS(Postoperative day 1 before packing extraction)
研究者
Zdenek Rusavy
M.D., Ph.D.
Charles University, Czech Republic