Laparoscopic Adhesiolysis for Chronic Abdominal Pain Revisited
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Change in pain
研究概览
简要总结
Chronic abdominal and pelvic pain is a common complaint following peritoneal surgery, affecting 20-40% of patients. Adhesions account for 60% of chronic postoperative pain cases, suggesting that adhesiolysis can play an important role in the management of such pain. Despite initial promising results regarding the effect of adhesiolysis on post-operative pain, implementation of the procedure has been challenging. The major problems associated with adhesiolysis for pain are recurrence of pain, need for invasive diagnosis with high rates of 'negative' laparoscopies, and inadvertent bowel injury during surgery. However, diagnosis and treatment of adhesions may be improved through the use of novel cine-MRI techniques, and with application of anti-adhesion barriers following adhesiolysis.
In this study the investigators evaluate a new practice-based approach to the problem of chronic post-operative pain caused by adhesions. This practice-based approach includes use of a novel imaging technique for adhesions (cine-MRI) and shared decision making. Cine-MRI holds promise to diagnose and map adhesions. Thus patients with no adhesions, or high risk for bowel injury, can be waived from surgical treatment. By using anti-adhesion barriers the investigators attempt to prevent adhesion reformation and improve long-term outcomes of adhesiolysis.
详细描述
Laparoscopic adhesiolysis for chronic abdominal pain revisited.
Background Prevalence of chronic pain following abdominal surgery may be as high as 40%. Postoperative chronic pain can be caused by various reasons, but adhesions are identified as the most likely cause in more 60% of cases. Early studies of adhesiolysis reported high success rates, up to 80%, in patients with no other cause of pain. Nonetheless, adhesiolysis is now seldom used in the treatment of chronic abdominal pain. Controversy over laparoscopic adhesiolysis as treatment for abdominal pain was raised by the landmark trial of Swank et al. In this trial 100 patients were randomized after the diagnosis of adhesions was confirmed laparoscopy between adhesiolysis or diagnostic laparoscopy alone. In the adhesiolysis group 57% of patients reported long-term pain relief vs. 42% in the diagnostic group; this difference was not statistically significant. The authors concluded that adhesiolysis was not effective, and thereafter many surgeons discarded adhesiolysis as treatment for chronic abdominal pain.
However, there are some important critiques on this trial. First, a type II error by too low sample size cannot be excluded. Second, some experimental studies indicate that filmy adhesions, which may be disrupted by pneumoperitoneum in the control patient group, cause most pain. Third, adhesions might have reformed after adhesiolysis, diminishing long term effects in the adhesiolysis group. Adhesion formation and reformation can effectively be reduced by application of an anti-adhesion barrier. Apart from these critiques, there is no evidence for effective alternative treatments.
Patients with chronic postoperative pain are frequently referred to the outpatient clinical of the surgery department of the RadboudUMC for expert opinion. Since 2012 the investigators started a 'patient participation in care' project for this patient group, in which laparoscopic adhesiolysis was reintroduced as treatment for chronic abdominal in selected cases. Cine- MRI was used as a novel non-invasive tool to diagnose adhesions, waiving the need for a negative laparoscopy in patient with other causes for chronic abdominal pain. Cine- MRI was recently developed as a non-invasive diagnostic tool to detect symptomatic adhesions, with reported sensitivity between 85%- 89% and specificity between 93%-95%. Decision for operative treatment was made based on individualized assessment of benefits and risks based on cine-MRI results in a shared-decision approach. Further, all patients undergoing adhesiolysis were treated with an anti-adhesion barrier.
Purpose & Research question The aim of this study is to evaluate the results of this novel shared decision approach using cine-MRI in a cohort of patients referred to the outpatient clinical of the department of surgery with chronic postoperative pain. Comparison is made between patients undergoing laparoscopic adhesiolysis, patients conservatively treated with adhesions on cine-MRI, and patients with no adhesions on cine-MRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in pain
时间窗: long-term >6 months to 3 years following surgery or cineMRI
measured by a verbal rating pain change scale (VRCS)
次要结局
- Frequency of pain(long-term >6 months to 3 years following surgery or cineMRI)
- Current pain(long-term >6 months to 3 years following surgery or cineMRI)
- Daily discomfort(long-term >6 months to 3 years following surgery or cineMRI)
- Healthcare utilization(long-term >6 months to 3 years following surgery or cineMRI)
- Complications of surgery/ adhesiolysis(Peri-operative (up to 30 days after adhesiolysis))
