Natural Course of Pain Following Surgery Through an Abdominal Incision: The Role of Adhesions and Other Factors in Chronification of Abdominal Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 650
- 试验地点
- 7
- 主要终点
- Risk factors for development of chronic pain
研究概览
简要总结
Chronic abdominal pain is highly prevalent in patients undergoing abdominal surgery. Adhesions are reported to be one of the most common causes of chronic pain after surgery. There is little epidemiological data on the natural course and risk factors of pain. In this study the investigators will assess risk factors for chronic pain and natural course by tracking pain scores through an app in a cohort of 1,500 patients undergoing abdominal surgery. In part two of the study patients with persistent abdominal pain at 12 months, that meet IASP criteria for chronic pain will have clinical investigations to determine the cause of their pain. This investigation includes cineMRI for diagnosis and mapping of adhesions.
详细描述
Rationale: Chronic abdominal and pelvic pain are highly prevalent in among patients who had abdominal surgery in history. An estimate of 11-20% of all patients undergoing different kinds of abdominal surgery will develop chronic abdominal pain. Adhesions (a form of internal scar tissue) are the most common pathology found in patients undergoing diagnostic laparoscopy for pain. Other factors that might be associated with chronic post-operative pain are anxiety, depression, and female sex. Little is known about the natural course of pain after abdominal surgery, risk factors for developing chronic pain, and the mechanisms causing pain in patients with adhesions. In this longitudinal study the investigators will prospectively study the natural course of pain through repeated measurements, and predictive factors for chronification of pain after different types of abdominal surgery.
Objective: In Phase 1 the investigators will study the natural course of pain following abdominal surgery. Primary objective for phase 1 is to assess risk factors for chronic pain at 12 months after surgery; where chronic pain is defined as daily continues or intermittent pain with maximal pain scores of 4 or higher during more than 3 months in accordance to IASP criteria. As a pivotal secondary outcome we will describe and model the duration (days) of moderate (worst pain score 4 to 6) to severe pain (worst pain score 7 or higher), and assess factors that impact the chance in painscore using mixed models. In phase two the investigators will assess the impact of adhesions on chronic pain. Primary objective for phase two is to compare incidence and extent of adhesions on cineMRI between patients who developed chronic pain and patients who did not develop chronic pain at 12 months after surgery.
Study design: This is prospective cohort study, including 1,500 patients scheduled for elective abdominal surgery. In phase one, patients are asked to fill a comprehensive questionnaire, including quality of life assessment and a comprehensive assessment of potential predictive factors for chronic pain prior to surgery. Post-operatively pain symptoms will be monitored using short daily and weekly questionnaires taken by m-health and e-health techniques to study natural course of pain. A comprehensive assessment of pain, quality of life, and medical consumption will be taken at 3,6, and 12 months post-operatively.
In phase two of the study patients who developed chronic pain will be invited for mapping of adhesions using cineMRI. Results of mapping of adhesions using cineMRI in patients with chronic abdominal pain will be compared to mapping of adhesions in 100 patients matched for type of surgery and risk factors who did not develop chronic pain.
Study population: 1,500 patients undergoing elective abdominal surgery from different surgical subspecialties (e.g. colorectal, upper-GI, and gynaecological surgery), aged 18 years or older.
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
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Mental incompetence
- •Planned for laparoscopic cholecystectomy
- •Planned for Caesarean section
- •Additional exclusion criteria for phase two are:
- •Contra-indications for MRI (without contrast) including:
- •Severe claustrophobia
- •Metal splinters in eyes
- •Cerebral vascular clips
- •Electronic medical implants
- •Patients who do not want to be informed about potential incidental findings of MRI-scan
结局指标
主要结局
Risk factors for development of chronic pain
时间窗: 12 months
Prediction model for development of chronic post-operative abdominal pain, assessed using a dynamic prediction model. Potential factors are taken from baseline measurements, and the repeated measurements of the course of pain.
Incidence of adhesions on cineMRI in patients with chronic abdominal pain.
时间窗: 2 months
Primary outcome of the second phase of study in which patients with chronic pain will undergo clinical investigations determining the cause of their pain,
次要结局
- Health-related quality of life(12 months)
- Healthcare utilization(12 months)
- characteristics of adhesions on cineMRI(2 months)
- Return to daily activity/ work(12 months)
- incidence of chronic pain(12 months)
- Duration of moderate to severe pain(60 days post surgery)