The feasibility of pre-surgery self-voiding without intraoperative urinary catheterization in laparoscopic procedures for benign adnexal pathologies: A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. To evaluate the incidence of urinary tract symptoms and postoperative urinary tract infections (UTIs) in women with and without perioperative urinary catheterization.
研究概览
简要总结
Urinary catheterization is commonly performed during benign laparoscopic gynaecological surgeries to prevent urinary retention and facilitate surgical access. However, routine catheter use may increase the risk of catheter-associated urinary tract infections (CAUTIs), delay mobilization, and reduce patient comfort—especially when the surgery is short and minimally invasive. Current evidence on the necessity of catheterization in such cases is limited and inconsistent. This study seeks to determine whether avoiding routine catheterization can reduce postoperative UTIs without increasing urinary retention, thereby supporting safer, more patient-centred perioperative care.
This study will be a prospective randomized controlled trial (RCT) conducted in the Department of Obstetrics and Gynaecology at AIIMS, New Delhi. The trial will be conducted over a period of 2 years, beginning from the date of ethical clearance. The study population will consist of women aged between 15- and 45-years undergoing emergency or elective laparoscopic gynaecologic surgeries for benign conditions, including ovarian cystectomy, laparoscopic myomectomy, diagnostic laparoscopy, and other non-hysterectomy procedures.
Group A shall consist of non-catheterised patients while Group B will include catheterised patients. The non-catheterization, self-voiding group (Group A) will not be catheterized unless intraoperative conditions necessitate it (e.g., prolonged surgery, bladder injury). While the catheterization group (Group A) will receive an indwelling Foley catheter immediately after induction of anaesthesia, which will be removed at the end of surgery or retained postoperatively as per the operating surgeon’s discretion. Allocation concealment will be ensured through unique identification numbers. Both the groups shall be required to void preoperatively. All surgeries will be performed by experienced gynaecologic laparoscopic surgeons under appropriate anaesthesia using standard laparoscopic techniques. Both groups will receive perioperative care as per institutional protocols. The type of surgery and the treatment received shall be unaffected by the allocation group in either case.
Data will be collected using a structured case record form designed for this study. Preoperative information including patient demographics, medical history, surgical indication, and baseline urine microscopy and culture will be recorded. Intraoperative variables such as type and duration of surgery and anesthesia, estimated blood loss, and need for intraoperative catheterization (if any) will also be documented. Postoperative assessments will include time to first spontaneous void, incidence of urinary retention (defined as inability to void within 6 hours post-surgery or post-void residual volume >150 mL measured by ultrasound), need for re-catheterization and the presence of any signs and symptoms of UTI. Postoperative urine samples will be collected for repeat urine microscopy and culture before discharge or within 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Scheduled for emergency or elective laparoscopic procedures for benign gynecological conditions (infertility, ectopic pregnancy, ovarian cystectomy, myomectomy, ectopic pregnancies) ASA physical status I–II Those willing to give informed written consent.
排除标准
- 未提供
结局指标
主要结局
1. To evaluate the incidence of urinary tract symptoms and postoperative urinary tract infections (UTIs) in women with and without perioperative urinary catheterization.
时间窗: 1. Baseline (preoperatively) | 2. Within 48 hours postoperatively | 3. Within 7 days postoperatively.
2. To evaluate the incidence of microscopic hematuria in women with and without perioperative urinary catheterization.
时间窗: 1. Baseline (preoperatively) | 2. Within 48 hours postoperatively | 3. Within 7 days postoperatively.
次要结局
- 1. To assess the rate of postoperative urinary retention and need of urinary re-catheterisation in both groups.(2. To compare the length of hospital stay among two groups.)
