Natural Course of Pain Following Surgery Through an Abdominal Incision
NCT ID: NCT04088838
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
650 participants
OBSERVATIONAL
2020-01-01
2025-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Main study parameters/endpoints: Main study outcome for phase one are risk factors for development of chronic pain at 12 months post-operative. Pivotal secondary outcomes include description of the median duration (days) of moderate to severe abdominal pain following abdominal surgery, and modelling of factors that impact change in abdominal pain after surgery. Other secondary outcomes include health-related quality of life, healthcare utilization, and return to daily activity or work.
Main outcomes for phase two is the percentage of patients with adhesions on cineMRI as compared between patients with and without chronic pain. Secondary outcomes relate to the appearance of adhesions on cineMRI, and included extent and the loss of shear.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In phase one of this cohort study patients will be asked to fill repeated questionnaires on pain and potential risk factors for chronic pain. The intake questionnaire prior to surgery will take approximately 60 minutes to fill. Post-operatively we will send short questionnaires that take 2-5 minutes to fill. These questionnaires will be send daily during the first 60 days after surgery and weekly afterwards. A more comprehensive questionnaire on abdominal pain and complaints that takes 45 minutes to complete will be send at 3,6, and 12 months post-operative. There are no risks related to participation in this study, nor are there direct benefits.
Patients participating in part two of this cohort will undergo cineMRI to evaluate if pain symptoms might relate to adhesions form previous surgery. The MRI will take approximately 20 minutes to perform. MRI is a non-invasive imaging technique without health risks. However, there is a risk of incidental findings that do not relate to the subject of this study (adhesion formation). Patients who do not want to be informed about incidental findings will be excluded from phase two. In a subset female patients who had pelvic surgery and resection of the uterus an additional transvaginal ultrasound will be made. Like MRI, this is a non-invasive diagnostic test without health risks. There is some additional inconvenience by the use of a transvaginal ultrasound prove. The test will take approximately 15 min.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients undergoing abdominal surgery
All adult patients undergoing elective abdominal surgery are eligible. Abdominal surgery includes each operation in which the peritoneal cavity is openen, i.e. laparotomy or laparoscopy.
Pain tracking app
In this study no clinical interventions are made. Patients scheduled for surgery will be treated according to the standard of care. All patients enrolled will have an application installed to track their pain symptoms through short daily and weekly questionnaires.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pain tracking app
In this study no clinical interventions are made. Patients scheduled for surgery will be treated according to the standard of care. All patients enrolled will have an application installed to track their pain symptoms through short daily and weekly questionnaires.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Planned for elective abdominal surgery, e.g. laparotomy or laparoscopy
* 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
* Mental incompetence
* Planned for laparoscopic cholecystectomy
* Planned for Caesarean section
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Radboud University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Maasziekenhuis Pantein
Boxmeer, Gelderland, Netherlands
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Maastricht Universitair Medisch Centrum+
Maastricht, Limburg, Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Slingeland Hospital
Doetinchem, , Netherlands
Gelderse Vallei Hospital
Ede, , Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
van den Beukel BAW, Stommel MWJ, van Leuven S, Strik C, IJsseldijk MA, Joosten F, van Goor H, Ten Broek RPG. A Shared Decision Approach to Chronic Abdominal Pain Based on Cine-MRI: A Prospective Cohort Study. Am J Gastroenterol. 2018 Aug;113(8):1229-1237. doi: 10.1038/s41395-018-0158-9. Epub 2018 Jun 27.
Strik C, van den Beukel B, van Rijckevorsel D, Stommel MWJ, Ten Broek RPG, van Goor H. Risk of Pain and Gastrointestinal Complaints at 6Months After Elective Abdominal Surgery. J Pain. 2019 Jan;20(1):38-46. doi: 10.1016/j.jpain.2018.07.010. Epub 2018 Aug 11.
Randall D, Joosten F, Ten Broek RP, Gillott R, Bardhan KD, Strik C, Prins W, van Goor H, Fenner JW. A novel diagnostic aid for intra-abdominal adhesion detection in cine-MRI: pilot study and initial diagnostic impressions. Br J Radiol. 2017 Aug;90(1077):20170158. doi: 10.1259/bjr.20170158. Epub 2017 Jul 14.
van den Beukel BA, de Ree R, van Leuven S, Bakkum EA, Strik C, van Goor H, Ten Broek RPG. Surgical treatment of adhesion-related chronic abdominal and pelvic pain after gynaecological and general surgery: a systematic review and meta-analysis. Hum Reprod Update. 2017 May 1;23(3):276-288. doi: 10.1093/humupd/dmx004.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL68853.091.19
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-5241
Identifier Type: -
Identifier Source: org_study_id