chronic pain peritoneal adhesions
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Phase 1, initial inclusion: - Adult patients, 18 years - scheduled for elective abdominal surgery (e.g. laparotomy or laparoscopy), In phase 2 of the study (cineMRI) we will select a subgroup of the original cohort meeting these additional criteria: - Chronic pain at 12 months post-operative as defined by International Association for Study of Pain (IASP) criteria: - Daily pain in the past three months - Pain is continues or intermittent - Pain scores for the worst pain are 4 or higher - patient has developed abdominal pain related to the surgical procedure OR - patients without chronic pain who are matched for type of surgery and risk factors for developing chronic pain.
Exclusion criteria
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 - Patient who does not want to be informed about potential incidental findings of MRI-scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study outcome for phase one is the median and range of duration (days) of abdominal pain during rest and during daily activities following abdominal surgery. Main outcomes for phase two is the percentage of patients with adhesions on cineMRI as compared between patients with and without chronic pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are predictive factors for development of pain, health-related quality of life, healthcare utilization, and return to daily activity or work. Predictors will be used to model a prediction model using regression techniques. Secondary outcomes for phase 2 relate to the appearance of adhesions on cineMRI, and included extent and the loss of shear. | — |
Countries
Netherlands
Outcome results
None listed