Natural Course of Pain Following Surgery Through an Abdominal Incision
Natural Course of Pain Following Surgery Through an Abdominal Incision
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.
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 surgery will develop chronic abdominal pain. Adhesions (a form of internal
 scar tissue) are the most common pathology found in patients undergoing diagnostic
 laparoscopy for pain. Other factors that might be associated with chronic post-operative pain
 are anxiety, depression, and female sex. Little is known about the natural course of pain
 after abdominal surgery, risk factors for developing chronic pain, and the mechanisms causing
 pain in patients with adhesions. In this longitudinal study the investigators will
 prospectively study the natural course of pain through repeated measurements, and predictive
 factors for chronification of pain after different types of abdominal surgery.

 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.
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