Post-operative Residual Voiding Volume Following Bulking and Vaginal Prolapse Surgery and Impact on In-hospital Stay
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Residual urine
研究概览
简要总结
Post operative urinary retention is a commonly observed complication following women undergoing urogynecology surgery.
The trial includes patients undergoing bulking and vaginal prolapse surgery, who are randomized in two postoperative groups prior to surgery in order to test two void regimes. One group includes a strict voiding regime, where patients are discharged when voiding volume is minimum 150 ml and residual volume is maximum 200 ml. Comparatively, the minimalistic voiding group discharge patients after one spontaneous voiding, independent of voiding volume and residual volume.
The primary aim of this study is to evaluate time to discharge in two different voiding trials techniques (strict vs minimalistic) after anterior, posterior or vaginal vault prolapse surgery as well as bulking surgery. Secondly, to register the development of postoperative urinary tract infection, urine retention, gynecological pain and patients' calls to the gynecological ward after discharge.
详细描述
Project description Aim The primary aim of this study is to evaluate time to discharge in two different voiding trials techniques (strict vs minimalistic) after anterior, posterior or vaginal vault prolapse surgery as well as bulking surgery.
Secondly, to evaluate the frequency of postoperative urinary tract infection, urine retention and pain as well as patients' calls to the gynecological ward after discharge.
Hypothesis The hypothesis is that the intervention group (minimalistic trial) will have an earlier discharge and fewer complications compared to the other group (strict trial).
Materials and methods The study will be performed as a two-armed parallel randomized controlled trial. Relevant patients at Odense University Hospital will be informed about the study at the preoperative consultation.
Prior to inclusion all patients are provided with verbal and written information regarding the study protocol and they give their informed consent. All patients will be randomized by a computer-generated list in a ratio of 1:1 to either strict or minimalistic regime. Randomization is done using Redcap. An independent statistician generates the random allocation sequence. The study will be blinded for the operating doctor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •• Women who undergo anterior, posterior or vaginal vault prolapse surgery or bulking surgery at the departments of obstetric and gynecology, OUH.
- •Women who have the catheter removed at the operating room.
- •Women >18 years old.
排除标准
- •Any surgery performed by due to malignancy
- •Previous cancer in the pelvic area
- •Previous radiation therapy in the pelvic area
- •Previous surgery in the pelvic area
- •Patients not understanding Danish
- •Patients with mental or similar illness
- •Patients with multiple sclerosis or diabetes type 1
- •Patients with late KAD removal based on per operative assessment
结局指标
主要结局
Residual urine
时间窗: 12 hours postoperatively
Residual urine after surgery
次要结局
未报告次要终点
研究者
Martin Rudnicki
Professor
Odense University Hospital