Natural course of Pain following surgery through an Abdominal INcision: The Role of Adhesions and other factors in Chronification of abdominal pain

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
we will prospectively study the natural course of pain through repeated
measurements, and predictive factors for chronification of pain after different
types of abdominal surgery.

Primary objective is to elucidate the natural course of pain after abdominal
surgery. Secondary objectives are assessment of risk factors for development of
chronic pain after surgery, and comparison of adhesion formation between
patient with and without development of chronic pain by mapping using cineMRI.

This is longitudinal 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.

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
no 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.