Natural Course of Pain Following Surgery Through an Abdominal Incision

NCT04088838 | Active Not Recruiting DMC

• 2 other identifiers: 2019-5241NL68853.091.19
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 7

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 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.

Conditions

Adhesions Abdominal; Adhesions Pelvic; Surgery Induced Tissue Adhesions; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Risk factors for development of chronic pain

  Prediction model for development of chronic post-operative abdominal pain, assessed using a dynamic prediction model. Potential factors are taken from baseline measurements, and the repeated measurements of the course of pain.

  12 months

• Incidence of adhesions on cineMRI in patients with chronic abdominal pain.

  Primary outcome of the second phase of study in which patients with chronic pain will undergo clinical investigations determining the cause of their pain,

  2 months

Secondary Outcomes (6)

• incidence of chronic pain

  12 months

• Duration of moderate to severe pain

  60 days post surgery

• Health-related quality of life

  12 months

• Return to daily activity/ work

  12 months

• Healthcare utilization

  12 months

Study Arms (1)

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.

Other: Pain tracking app

Interventions

Pain tracking app OTHER

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.

Patients undergoing abdominal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with undergoing different types of abdominal surgery (laparotomy and laparoscopy). Included are all patients undergoing elective surgery. Patients undergoing laparoscopic cholecystectomy and caesarean section are excluded because both are very frequent procedures with a low risk of chronic post-operative pain and low risk of adhesions. These procedure could therefore significantly impact the power of the study. Although patients after laparoscopic cholecystectomy frequently report pain, these pain symptoms are often attributable to persistence of pre-existing pain. There are known difficulties in differential diagnosis of symptomatic cholelithiasis and dyspepsia, that might interfere with indication for cholecystectomy

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (7)

Maasziekenhuis Pantein

Boxmeer, Gelderland, 5830 AB, Netherlands

Location

Radboud University Medical Center

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Maastricht Universitair Medisch Centrum+

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Slingeland Hospital

Doetinchem, Netherlands

Location

Gelderse Vallei Hospital

Ede, Netherlands

Location

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 29946174 BACKGROUND

• 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.

  PMID: 30107242 BACKGROUND

• 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.

  PMID: 28707532 BACKGROUND

• 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.

  PMID: 28333221 BACKGROUND

MeSH Terms

Conditions

Tissue Adhesions; Chronic Pain

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 13, 2019
• Study Start: January 1, 2020
• Primary Completion: July 18, 2024
• Study Completion: July 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 2 years after completion of the study. No time limit is associated with storage of data in the aforementoined archive.
• Access Criteria: Data will be made available upon reasonable request. Request will be evaluated by the steering group of the study. Request will be granted when meeting the following criteria: * Analysis plan meeting requirements as set by Dutch law and regulations for medical research and privacy. * Data is made available for the research question as proposed in the analysis plan. * The research question has not posed previously by the steering groups or in another request. * A timeframe during which analysis will be performed will be areed upon. If analysis is not completed within this time frame, the steering group might make the data available again to other researcher for this research question. * depending on the research question the steering group might propose to be involved as co-authors * In case of data request from researchers of a commercial party additional criteria might apply

Locations

NL (7)