Natural Course of Pain Following Surgery Through an Abdominal Incision (NCT04088838) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Natural Course of Pain Following Surgery Through an Abdominal Incision
Netherlands650 participantsStarted 2020-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Adult patients, aged above 18 years
* Planned for elective abdominal surgery, e.g. laparotomy or laparoscopy
For phase two of this study we will recruit patients from the group that participated in phase 1. Additional inclusion criteria for phase two:
* Patients who developed chronic post-operative abdominal pain according to IASP criteria:
* Daily pain in the past three months
* Pain is continues or intermittent
* Pain scores for the worst pain are 4 or higher
* Or patients without chronic pain (n=100) who are propensity matched for type of surgery and risk factors for developing chronic pain.
Exclusion Criteria:
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Risk factors for development of chronic pain
Timeframe: 12 months
2
Incidence of adhesions on cineMRI in patients with chronic abdominal pain.