Single Port Laparoscopy Versus Conventional Laparoscopy for Benign Adnexal Disease - A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
Keyhole surgery for adnexal disease has traditionally been performed using three or four small incisions. The last years a new operating method has been introduced. This method makes use of only one incision of 2 cm in the umbilicus. This method is less invasive, and it might benefit the patient through less postoperative pain and a higher satisfaction with the cosmetic result. So far, many studies have shown that this new method is feasible for adnexal disease, but its superiority compared to conventional laparoscopy is to be proven. This study aims to show this difference.
The investigators aim to compare experienced postoperative pain and use of analgesics in patients undergoing single port laparoscopy for benign adnexal disease with conventional laparoscopy. The investigators hypothesize that the patients will experience less postoperative pain and use less analgesic in the single port laparoscopy group.
Further, the investigators aim to compare the satisfaction with the cosmetic results in the two groups. In addition, blood loss, operating time, complications and conversion to conventional laparoscopy will be registered in the two groups.
详细描述
Although there are many reports indicating that single port laparoscopy for benign adnexal disease is feasible, there have to date not been published any randomized studies proving a superior outcome compared to conventional laparoscopy.
Theoretically, there are several advantages with a single port access. Because only one incision is made in place of several, less postoperative pain could be expected. The incision made is slightly larger (2 cm) than the ones used in conventional laparoscopy. It could therefore be easier to evacuate carbon dioxide gas (CO2) out of the abdomen after the operation, resulting in less shoulder tip pain, which is a common discomfort postoperatively. Carbon dioxide gas is considered to be responsible for postoperative shoulder tip pain due to peritoneal stretching and diaphragmatic irritation (Alexander et al. 1987, Sarli et al. 2000). The better cosmetic result due to only one incision is apparent. If this improvement makes a different for the patients, is yet to be proven.
There might be fewer complications with single-port laparoscopy compared to conventional laparoscopy. As mentioned above, serious complications like bowel and vessel injury, mostly occurring when Verres needle or a trocar is introduced through the abdominal wall. By reducing the number of trocars introduced, these complications might occur less commonly.
Performing a randomized controlled trial will bring more knowledge to whether single port laparoscopy for benign adnexal disease will truly benefit the patients compared to the established operating method for this condition.
Surgical technique:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ≥ 18 years.
- •ASA score 1 or
- •Presumed benign ovarian disease or a hereditary cancer risk.
- •Ovarian cyst ≤ 6 cm.
排除标准
- •Ovarian cyst > 6 cm.
- •Endometrioma.
- •Endometriosis.
- •History of chronic pelvic pain.
- •Known severe intra abdominal adhesions.
- •Daily use of analgesics.
- •Inability to understand Norwegian or English.
结局指标
主要结局
Postoperative pain
时间窗: 6 hours
Experienced pain over the last six hours measured on a VAS scale.
次要结局
- Satisfaction with cosmetic result(2 months postoperatively)
- Operation time(0 hours after the operation)
- Blood loss(0 hours after the operation)
- Complications(Two months)
- Shoulder tip pain(24 hours)
- Postoperative pain(24 hours)