Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy, a Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- The use of analgesics for postoperative pain
研究概览
简要总结
In cases of benign adnexal mass laparoscopic surgery, women were randomized to two groups: transumbilical vs. transabdominal removal. Need for pain medication, postoperative pain and patients´ satisfaction were assessed between the groups, as well as surgeons´ opinions and costs.
详细描述
Women assigned to laparoscopic surgery for removal of a benign adnexal mass were randomly divided into two groups as regards surgery: a transumbilical (TU) group (n=21) and a transabdominal (TA) group (n=21). General anesthesia and use of local anesthetics were standardized. Visual analog scale (VAS) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours. Investigators also investigated the expenses related to endobags and trocars. Further, peri- and postoperative complications were recorded. Investigators inquired about patient satisfaction as well as the surgeons' opinions of the alternative methods available.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The criteria for inclusion were scheduled laparoscopy for oophorectomy, salpingo-oophorectomy or cyst enucleation.
排除标准
- •The exclusion criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol),
- •language difficulties (inability to understand and speak Finnish or Swedish)
- •and suspicion of malignancy.
结局指标
主要结局
The use of analgesics for postoperative pain
时间窗: Change in 24 hours after surgery
The total amount of analgesics used measured by use of Oxycodone (mg)
次要结局
- Complications(The first six months after the surgical intervention)
- Surgeon perception of both techniques(After one month after the operation)
- Cosmetic outcome(At baseline and 6 months after the surgery)
- Postoperative pain scores(Change in 24 hours after surgery)
- Nausea(Change in 24 hours after surgery)
- Vomiting(Change in 24 hours after surgery)
- Length of hospital stay in hours(Up to one week)
- Quality of life(At baseline and 6 months after the surgery)
- Costs(During the surgery)
- Length of need of postoperative pain medication(Change in one month after surgery)
研究者
Päivi Päkarinen
MD PhD
Helsinki University Central Hospital