The Comparison of Surgical Outcomes to Conventional Hysterectomy and Manipulator-assisted Abdominal Hysterectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Duration of the surgical procedure
研究概览
简要总结
Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomy
Study design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Sequentially numbered, opaque envelopes were prepared according to randomization. The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure. The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope.
Study population: Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications.
Primary outcomes: (1) Operation Time.
Secondary outcomes: (1) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery) (2) intraoperative complications, (3) postoperative complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications
排除标准
- •Exclusion criteria were patients with additional procedures such as urogynecologic procedures, history of abdominal surgery with midline incision, patients with suspected gynecologic malignancy, endometriosis, tubo-ovarian abscess, pelvic organ prolapse, or those who refused to participate in the study and whose medical records could not be obtained.
结局指标
主要结局
Duration of the surgical procedure
时间窗: intraoperative
The surgical operative time was defined as the time from incision to completion of wound closure, also known as 'cut-to-close' time. In the manipulator-assisted abdominal hysterectomy group, the time of uterine manipulator placement was added to the operation time
次要结局
- Postoperative pain at 6th hours(At the 6th hours after the surgical procedure)
- intraoperative complications(Intraoperative)
- Postoperative pain at 24th hours(At the 24th hours after the surgical procedure)
- Postoperative complications(Postoperative, in the first month of the surgery)
研究者
pınar birol ilter
Specialist of obstetrics and gynecology
Dr. Lutfi Kirdar Kartal Training and Research Hospital