NCT06867614招募中不适用
Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy - a Single Blinded Randomized Comparative Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Vaginal Vault hematoma
研究概览
简要总结
The goal of this clinical trial is to compare the laparoscopic and transvaginal closure techniques of the vaginal vault in patients who perform TLH, regarding the risk of vaginal vault hematoma and other complications as vaginal cuff infection and sexual dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females consenting to do TLH all age groups with diagnoses of benign uterine conditions.
- •Women who are non-obese (normal or overweight women with BMI range 18-29.9).
- •Sexually active female.
排除标准
- •Diagnosed cases of pelvic malignancy
- •Diagnosed patients with Cervical intraepithelial neoplasia (CIN) or bacterial vaginosis (any infection should be treated)
- •Obese patients.
- •Patients currently undergoing treatment for any type of cancer
- •Patients with coagulopathy, bleeding/clotting disorders
- •Patients with any condition can impair wound healing: diabetes mellites, anemia, steroids
- •Patients with a previous history of radiation and allergy to sutures
- •Patients with clinically evident prolapse
研究组 & 干预措施
Vaginal approach
Active Comparator
Closure of vaginal vault after delivery of the specimen by vaginal suturing
干预措施: Total laparoscopic hysterectomy (Procedure)
Laparoscopic approach
Active Comparator
Closure of vaginal vault after delivery of the specimen by laparoscopic suturing
干预措施: Total laparoscopic hysterectomy (Procedure)
结局指标
主要结局
Vaginal Vault hematoma
时间窗: From 10 days postoperative to 30 days postoperative
It will be assessed by examination and ultrasound
次要结局
- Bleeding/spotting(From 10 days postoperative to 30 days postoperative)
- Vaginal infection:(From 10 days postoperative to 30 days postoperative)
- Vaginal prolapse(From 10 days postoperative to 30 days postoperative)
- Vaginal cuff granulation(From 10 days postoperative to 30 days postoperative)
- Sexual dysfunction(From 3 to 4 months post operative)
研究者
Rowan Ashraf AbdelHady Sakr
Resident
Ain Shams University
研究点 (1)
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