Chronic Pain, Adhesions
Conditions
Keywords
chronic abdominal pain, laparoscopic adhesiolysis, placebo
Brief summary
Laparoscopic adhesiolysis as a therapy for chronic pain is still controversial and long term effects are not known. The objective was to to evaluate long term effects of laparoscopic adhesiolysis for treating chronic abdominal pain. Therefore one hundred patients with abdominal pain attributed to adhesions were randomized to laparoscopic adhesiolysis or a placebo group with laparoscopy alone. Pain relief was assessed after 3, 6 and 12 months and 12-year follow-up.
Detailed description
This multi-center randomized controlled trial, included patients with chronic abdominal pain likely to be caused by adhesions from previous abdominal surgery. Chronic abdominal pain was defined as continues or intermittent abdominal pain of at least six months' duration. After excluding other pathology (see exclusion criteria) included patients underwent a diagnostic laparoscopy to confirm the adhesions and to exclude serious morbidity not visible with other diagnostics. If during laparoscopy adhesions were the only pathology present, patients were randomly assigned either to laparoscopic adhesiolysis or no treatment. For the randomization and surgical procedures the investigators refer to the original article. Patients were unaware of their treatment assignment and the outcome assessment was blinded. Abdominal pain and quality of life (QOL) were assessed pre-operatively and at 3, 6 and 12 months of follow-using a visual analog scale (VAS), verbal rating pain change score (VRCS) and the short form 36 (SF-36). After twelve months randomization was disclosed and placebo group patients with persisting abdominal pain could request laparoscopic adhesiolysis. After twelve year follow-up pain, QOL, medical history and analgesic intake were analyzed to assess the long term effects of laparoscopic adhesiolysis.
Interventions
PROCEDURELaparoscopic adhesiolysis
After diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed
PROCEDUREDiagnostic laparoscopy
After diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped.
Sponsors
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rijnstate Hospital
Maxima Medical Center
Catharina Ziekenhuis Eindhoven
Maasstad Hospital
Isala
Groene Hart Ziekenhuis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years and above with chronic abdominal pain that was likely to be caused by adhesions due to previous abdominal surgery were recruited. Before attributing abdominal pain to the existence of adhesions all patients had an extensional diagnostic work-up to exclude other pathology.
Exclusion criteria
* Current treatment by psychologist or psychiatrist * Use of laxatives, sedatives, morphine, antipsychotics, antidepressants, or drugs that stimulate the central nervous system * Abnormal outcome of standardized non-invasive diagnostics: * Biochemical investigation * Lactose tolerance tests or H2 respiration test * Feces analysis of worms and worm eggs * Ultrasound or CT scan of the abdomen * Radiographic studies of small and large bowel (or colonoscopy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short term pain relief | 12 months | Pain relief was assessed using a verbal rating pain change score (VRCS) |
| Long term pain relief | 12 year | Pain relief was assessed using a verbal rating pain change score (VRCS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic intake | 12 months and 12 year | — |
| Quality of life | 12 months and 12 year | QOL was assessed using the Short Form 36 |
| rate of consulting medical doctors | 12 months and 12 year | — |
| additional surgery because of persisting abdominal pain | 12 months and 12 year | patient questionnaire, patients medical record |
| Complications of treatment | 12 year | — |
Outcome results
None listed