Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery (BELT): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- postoperative pain
研究概览
简要总结
There have been no studies exploring the efficacy of incision support using an elastic abdominal binder after laparoscopy to date. The investigators performed therefore a randomized controlled trial to determine the effect of post-laparoscopic abdominal binder use on enhanced recovery after surgery (ERAS) in patients with gynecologic disease.
详细描述
An abdominal elastic binder (girdles, trusses, abdominal belts, longuette, etc.) is a wide belt that surrounds the abdomen and supports the incision . Abdominal binder is routinely used after open surgery and Cesarean section, because it has been reported, according to a recent systematic review, to facilitate enhanced recovery after surgery (ERAS) such as pain relief, reduced risk of seroma formation, improved respiratory function, and assisted physical function using additional support to the lower abdominal musculature.
However, the routine use of abdominal binder after laparoscopy has been challenged due to a potential risk of postoperative pulmonary complications and deep venous thrombosis due to increased intra-abdominal pressure. Also, abdominal binders after laparoscopy have been criticized for being uncomfortable and hot to wear and for impinging the breast line in females. Therefore, some laparoscopists prefer the use of abdominal binder in patients undergoing laparoscopy, while other laparoscopists did not. However, there have been no studies exploring the efficacy of incision support using an elastic abdominal binder after laparoscopy to date. The investigators performed therefore a randomized controlled trial to determine the effect of post-laparoscopic abdominal binder use on ERAS in patients with gynecologic disease.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 65 years
- •American Society of Anesthesiologists physical status (ASAPS) classification I-II
- •absence of pregnancy at the time of surgery
排除标准
- •body mass index (BMI) ≥30 kg/m2
- •history of abdominal surgery within 6 months
- •history of ventral or incisional hernia
- •walking disabilities (or walking with the assistance of crutches or a walker)
- •chronic obstructive respiratory disease
- •stage IV cancer,
- •chronic pain syndrome (defined as daily intake of opioids for chronic back pain, chronic headache, or fibromyalgia)
- •inability to fill out the questionnaire
研究组 & 干预措施
Experimental group
In subjects allocated to the abdominal binder group, the abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea) was applied before leaving the operating room. The binder was placed on the abdomen across the laparoscopic incision, with the upper border not higher than the lower margin of the rib cage, ensuring minimal restriction of lateral costal expansion and diaphragmatic excursion. Subjects were carefully instructed to use the abdominal binder during at least the first 2 consecutive days and night, and to reposition the abdominal binder correctly when needed.
干预措施: Experimental group (Device)
Control group
In subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder.
干预措施: Control group (Device)
结局指标
主要结局
postoperative pain
时间窗: at 48 hours after surgery
Subjects rated postoperative pain intensity using a visual analog scale (VAS) at 12, 24, and 48 hours after surgery. The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".
次要结局
- Incentive spirometry performance(at 24 hours after surgery)
- limitation of walking ability(at 48 hours after surgery)
研究者
Taejong Song
Professor
Kangbuk Samsung Hospital