NCT04434066已完成不适用
A Comparison of Perioperative and Patient-Centered Outcomes with Abdominal Versus Vaginal Morcellation: a Randomized-Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Mean difference in total operating room time
研究概览
简要总结
The purpose of the study is to investigate differences in perioperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in participants undergoing laparoscopic total hysterectomies in a randomized controlled trial.
详细描述
The purpose of the proposed study is to investigate differences in intraoperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in subjects undergoing laparoscopic total hysterectomies in a randomized surgical trial.
Objectives:
- To evaluate differences in total operating time between subjects undergoing AM compared to VM.
- To evaluate differences in morcellation time between AM and VM.
- To evaluate differences in the amount of total narcotic use during hospital admission between AM and VM through morphine milligram equivalents (MME).
- To evaluate differences in the patient's subjective pain assessment via Visual Analogue Scale (VAS) before surgery, at 2-weeks, and at 6 week post-operative visits in both AM and VM groups.
- To evaluate differences in the patient's pain medication usage as reported by the patient verbally at 24-hours post-operatively and 2-weeks post surgery between AM and VM groups.
- To evaluate differences in body image survey (BIS) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
- To evaluate differences in overall Quality of Life (QoL) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
- To evaluate differences in Quality of Recovery (QoR) scores at enrollment and at 24-hours post-operatively, and then 2-weeks post surgery between AM and VM group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All benign total laparoscopic hysterectomy and/or robotic-assisted hysterectomy, +/- unilateral salpingo-oophorectomy or bilateral salpingo-oophorectomy
- •Adnexectomy, cystectomy, tubal procedures at time of hysterectomy
- •Age >18 years old
- •Uterus >12 weeks, or >250 grams (based on imaging), or requiring morcellation based on clinical judgment at time of pre-operative enrollment
- •English and Spanish speaking
排除标准
- •Pre-malignant conditions (i.e. endometrial intraepithelial neoplasia, high-grade cervical intraepithelial neoplasia), known gynecologic malignancy, and any contraindications to abdominal or vaginal morcellation
- •Planned concurrent procedures (i.e. hernia repair, bowel resections, anti-incontinence procedures, prolapse repair, and mastectomy)
- •Appendectomy for endometriosis is not excluded
- •No chronic pain disorders requiring medical management (endometriosis can be included)
- •Planned abdominal hysterectomy or vaginal hysterectomy candidates
- •Conversion to laparotomy or inability to complete morcellation
- •Contraindications to laparoscopy
结局指标
主要结局
Mean difference in total operating room time
时间窗: intraoperative
Total operating room time is defined as skin incision to skin closure
次要结局
- Mean difference from baseline in Body Image Scale Score to 6-weeks post-operatively(through study completion up to 6-weeks post-operatively)
- Rates of Post-Operative Complications(through study completion up to 6-weeks post-operatively)
- Mean difference from baseline in Pain Visual Analogue Scale to 6-weeks post-operatively(through study completion up to 6-weeks post-operatively)
- Mean difference from baseline in Quality of Life Score to 6-weeks post-operatively(through study completion up to 6-weeks post-operatively)
- Morcellation Time(intraoperative)
- Mean difference from baseline in Quality of Recovery Score to 2-weeks post-operatively(through study completion up to 6-weeks post-operatively)
- Mean difference in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation(after surgery to 2-weeks post-operatively)
研究者
Kimberly Kho
Associate Professor
University of Texas Southwestern Medical Center
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Postoperative Pain Control Results Using Periarticular Versus Intra-capsular Injection of Bupivacaine Liposome Injectable Suspension in Total Knee ArthroplastyOsteoarthritis, KneeNCT02166632Broward Health50
终止
4 期
The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Patients Undergoing Elective Major Abdominal and/or Pelvic SurgeryHemostasis, SurgicalNCT00350519Johnson & Johnson Pharmaceutical Research & Development, L.L.C.37
撤回
不适用
Operative Versus Nonoperative Treatment for Scapula FracturesScapula FractureClavicle FractureNCT00849771Vanderbilt University
招募中
不适用
Comparison of the effects of adding drug fentanyl via two different routes in patients undergoing cataract surgeries.CTRI/2018/04/013177Bhagat Phool Singh Government Medical College for Women
已完成
不适用
Comparing the peri-procedural events and effect of two techniques ( using microscope vs using endoscope) for removing pituitary tumor.CTRI/2015/08/006134ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI350