Status:
ACTIVE_NOT_RECRUITING
Natural Course of Pain Following Surgery Through an Abdominal Incision
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Adhesions Abdominal
Adhesions Pelvic
Eligibility:
All Genders
18+ years
Brief 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 epidemiol...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT04088838
Start Date
January 1 2020
End Date
July 1 2025
Last Update
December 31 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Maasziekenhuis Pantein
Boxmeer, Gelderland, Netherlands, 5830 AB
2
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6500HB
3
Maastricht Universitair Medisch Centrum+
Maastricht, Limburg, Netherlands, 6202 AZ
4
Rijnstate Hospital
Arnhem, Netherlands