Benefit of Laparoscopic Adhesiolysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Short term pain relief
研究概览
简要总结
Laparoscopic adhesiolysis as a therapy for chronic pain is still controversial and long term effects are not known. The objective was to to evaluate long term effects of laparoscopic adhesiolysis for treating chronic abdominal pain.
Therefore one hundred patients with abdominal pain attributed to adhesions were randomized to laparoscopic adhesiolysis or a placebo group with laparoscopy alone. Pain relief was assessed after 3, 6 and 12 months and 12-year follow-up.
详细描述
This multi-center randomized controlled trial, included patients with chronic abdominal pain likely to be caused by adhesions from previous abdominal surgery. Chronic abdominal pain was defined as continues or intermittent abdominal pain of at least six months' duration. After excluding other pathology (see exclusion criteria) included patients underwent a diagnostic laparoscopy to confirm the adhesions and to exclude serious morbidity not visible with other diagnostics. If during laparoscopy adhesions were the only pathology present, patients were randomly assigned either to laparoscopic adhesiolysis or no treatment. For the randomization and surgical procedures the investigators refer to the original article. Patients were unaware of their treatment assignment and the outcome assessment was blinded. Abdominal pain and quality of life (QOL) were assessed pre-operatively and at 3, 6 and 12 months of follow-using a visual analog scale (VAS), verbal rating pain change score (VRCS) and the short form 36 (SF-36). After twelve months randomization was disclosed and placebo group patients with persisting abdominal pain could request laparoscopic adhesiolysis. After twelve year follow-up pain, QOL, medical history and analgesic intake were analyzed to assess the long term effects of laparoscopic adhesiolysis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients aged 18 years and above with chronic abdominal pain that was likely to be caused by adhesions due to previous abdominal surgery were recruited. Before attributing abdominal pain to the existence of adhesions all patients had an extensional diagnostic work-up to exclude other pathology.
排除标准
- •Current treatment by psychologist or psychiatrist
- •Use of laxatives, sedatives, morphine, antipsychotics, antidepressants, or drugs that stimulate the central nervous system
- •Abnormal outcome of standardized non-invasive diagnostics:
- •Biochemical investigation
- •Lactose tolerance tests or H2 respiration test
- •Feces analysis of worms and worm eggs
- •Ultrasound or CT scan of the abdomen
- •Radiographic studies of small and large bowel (or colonoscopy)
结局指标
主要结局
Short term pain relief
时间窗: 12 months
Pain relief was assessed using a verbal rating pain change score (VRCS)
Long term pain relief
时间窗: 12 year
Pain relief was assessed using a verbal rating pain change score (VRCS)
次要结局
- Complications of treatment(12 year)
- Quality of life(12 months and 12 year)
- Analgesic intake(12 months and 12 year)
- additional surgery because of persisting abdominal pain(12 months and 12 year)
- rate of consulting medical doctors(12 months and 12 year)
研究者
Marijke Molegraaf
Drs
Groene Hart Ziekenhuis