Chronic Pain Clinical Trial
Official title:
Laparoscopic Adhesiolysis for Chronic Abdominal Pain Revisited
Chronic abdominal and pelvic pain is a common complaint following peritoneal surgery,
affecting 20-40% of patients. Adhesions account for 60% of chronic postoperative pain cases,
suggesting that adhesiolysis can play an important role in the management of such pain.
Despite initial promising results regarding the effect of adhesiolysis on post-operative
pain, implementation of the procedure has been challenging. The major problems associated
with adhesiolysis for pain are recurrence of pain, need for invasive diagnosis with high
rates of 'negative' laparoscopies, and inadvertent bowel injury during surgery. However,
diagnosis and treatment of adhesions may be improved through the use of novel cine-MRI
techniques, and with application of anti-adhesion barriers following adhesiolysis.
In this study the investigators evaluate a new practice-based approach to the problem of
chronic post-operative pain caused by adhesions. This practice-based approach includes use of
a novel imaging technique for adhesions (cine-MRI) and shared decision making. Cine-MRI holds
promise to diagnose and map adhesions. Thus patients with no adhesions, or high risk for
bowel injury, can be waived from surgical treatment. By using anti-adhesion barriers the
investigators attempt to prevent adhesion reformation and improve long-term outcomes of
adhesiolysis.
Laparoscopic adhesiolysis for chronic abdominal pain revisited.
Background Prevalence of chronic pain following abdominal surgery may be as high as 40%.
Postoperative chronic pain can be caused by various reasons, but adhesions are identified as
the most likely cause in more 60% of cases. Early studies of adhesiolysis reported high
success rates, up to 80%, in patients with no other cause of pain. Nonetheless, adhesiolysis
is now seldom used in the treatment of chronic abdominal pain. Controversy over laparoscopic
adhesiolysis as treatment for abdominal pain was raised by the landmark trial of Swank et al.
In this trial 100 patients were randomized after the diagnosis of adhesions was confirmed
laparoscopy between adhesiolysis or diagnostic laparoscopy alone. In the adhesiolysis group
57% of patients reported long-term pain relief vs. 42% in the diagnostic group; this
difference was not statistically significant. The authors concluded that adhesiolysis was not
effective, and thereafter many surgeons discarded adhesiolysis as treatment for chronic
abdominal pain.
However, there are some important critiques on this trial. First, a type II error by too low
sample size cannot be excluded. Second, some experimental studies indicate that filmy
adhesions, which may be disrupted by pneumoperitoneum in the control patient group, cause
most pain. Third, adhesions might have reformed after adhesiolysis, diminishing long term
effects in the adhesiolysis group. Adhesion formation and reformation can effectively be
reduced by application of an anti-adhesion barrier. Apart from these critiques, there is no
evidence for effective alternative treatments.
Patients with chronic postoperative pain are frequently referred to the outpatient clinical
of the surgery department of the RadboudUMC for expert opinion. Since 2012 the investigators
started a 'patient participation in care' project for this patient group, in which
laparoscopic adhesiolysis was reintroduced as treatment for chronic abdominal in selected
cases. Cine- MRI was used as a novel non-invasive tool to diagnose adhesions, waiving the
need for a negative laparoscopy in patient with other causes for chronic abdominal pain.
Cine- MRI was recently developed as a non-invasive diagnostic tool to detect symptomatic
adhesions, with reported sensitivity between 85%- 89% and specificity between 93%-95%.
Decision for operative treatment was made based on individualized assessment of benefits and
risks based on cine-MRI results in a shared-decision approach. Further, all patients
undergoing adhesiolysis were treated with an anti-adhesion barrier.
Purpose & Research question The aim of this study is to evaluate the results of this novel
shared decision approach using cine-MRI in a cohort of patients referred to the outpatient
clinical of the department of surgery with chronic postoperative pain. Comparison is made
between patients undergoing laparoscopic adhesiolysis, patients conservatively treated with
adhesions on cine-MRI, and patients with no adhesions on cine-MRI.
Patients: Patients with chronic postoperative pain (>6 months) caused by adhesions as proven
by cine-MRI Intervention: Laparoscopic adhesiolysis with adhesion barrier Controls: - control
group 1: Patients with chronic postoperative pain and cine-MRI proven adhesions who had
conservative treatment - Control group 2 patients with alternative diagnosis who had
conservative treatment Outcome: • Change in symptoms (measured by Patients' Global Impression
of Change scale), current pain (measured by numeric rate scale), Healthcare utilization
(hospital visits, paramedic visits, medication)
Plan of investigation We will perform an analysis in a cohort of approximately 100 patients
who underwent Cine-MRI in the work-up for chronic abdominal pain. Adhesions were identified
in approximately 80 of the patients, 40 of them were operated and underwent laparoscopic
adhesiolysis (group 1). The other 40 patients waived operation for various reasons and
received conservative treatment (group 2). Patients with negative cine-MRI are analyzed as
group 3. In a few cases a diagnostic laparoscopy was performed in case history, physical
examination and cine-MRI were inconclusive. These patients will be analyzed as part of group
1.
Patients will be asked to participate in this study by telephone or letter. If agreed, a
questionnaire will be sent comparing pain, improvement of pain since treatment, use of
analgesics and other healthcare utilization between the operated and non-operated groups.
Further data on the operation and peri-operative complications are gathered from the case
records. Primary outcome is reduction or alleviation of pain. Secondary outcomes are current
pain score (measured by VAS), analgesics use and healthcare utilization. Additional secondary
outcomes for the operatively treated group are the incidence of conversion to open surgery,
and peri-operative complications.
Patients admitted to the outpatient clinic of the department of surgery for chronic
postoperative pain who underwent a cine-MRI are screened for eligibility.
Inclusion criteria are :
- Age ≥ 18 years
- Pain exists for at least 6 months postoperatively
Exclusion criteria are:
- Cine-MRI not performed for chronic pain (e.g. recurrent pain with episodes of bowel
obstructions)
;
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