Natural Course of Pain Following Surgery Through an Abdominal Incision
Active, not recruitingNCT04088838
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Natural Course of Pain Following Surgery Through an Abdominal Incision: The Role of Adhesions and Other Factors in Chronification of Abdominal Pain
- Conditions
- Adhesions Abdominal
- Adhesions Pelvic
- Surgery Induced Tissue Adhesions
- Chronic Pain
- Interventions
- Other: Pain tracking app
- Sponsor
- Radboud University Medical Center
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Start date
- 2020-01-01
- Primary completion
- 2024-07-18
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 7
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04088838