Sub vs Trans-umbilical Incision: A Patient's Satisfaction-centered Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in postoperative patient's aesthetic satisfaction
研究概览
简要总结
While some studies have suggested that subumbilical and transumbilical incisions have a similar clinical efficiency and safety, no study has yet evaluated their respective impact on patient's postoperative aesthetic satisfaction.
The objective of this randomised trial is to compare patient's postoperative aesthetic satisfaction depending on the type of incision which is performed during surgeries.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18-70 years old having a planned laparoscopic surgery with an umbilical first trocar at CHUS were included.
排除标准
- •Patients with a BMI > 40 or that had previous abdominal surgeries involving the umbilicus were excluded.
研究组 & 干预措施
Subumbilical incision
The subumbilical incision was standardised. A curvilinear horizontal incision was performed to be able to reach the base of the umbilicus. The aponeurosis was incised with a scalpel and the peritoneal layer was open with a Kelly clamp. The incision was completed with the Hasson technique and a X-stitch was used for closure.
干预措施: Subumbilical incision (Procedure)
Transumbilical incision
The transumbilical incision was also standardised, inverting the umbilicus with graspers, then incising vertically the skin to reach the umbilical physiological hernia to enlarge it. The incision was also completed with the Hasson technique and a X-stitch was used for closure.
干预措施: Transumbilical incision (Procedure)
结局指标
主要结局
Change in postoperative patient's aesthetic satisfaction
时间窗: 6 months
An inverted 10 points Wong-Baker facial grimace-type scale was used to assess patient's satisfaction. Although the french version of our questionnaire was not validated, the concept behind Wong-Baker facial scale have been in various studies. In the case of this study, a 10 point score was associated with the highest possible satisfaction regarding the aesthetic appearance of the umbilicus. Patient's aesthetic satisfaction regarding the umbilicus was recorded preoperatively (right before the surgery), 1 month post-op and 6 months post-op. The change in postoperative patient's aesthetic satisfaction was assessed between pre-op vs 1 month post-op, pre-op vs 6 months post-op and 1 month vs 6 months post-op.
次要结局
- Level of patient's awareness regarding the aesthetic appearance of the umbilicus(Pre-operative)