Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Benefit of Laparoscopic Adhesiolysis

Conditions
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Chronic Pain, Adhesions

Intervention / Treatment
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* Procedure: Laparoscopic adhesiolysis
* Procedure: Diagnostic laparoscopy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adhesiolysis group<br>Patients underwent laparoscopic adhesiolysis | Procedure: Laparoscopic adhesiolysis<br>* After diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed<br>|
| Placebo Comparator: Placebo group<br>Patients underwent diagnostic laparoscopy alone | Procedure: Diagnostic laparoscopy<br>* After diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term pain relief | Pain relief was assessed using a verbal rating pain change score (VRCS) | 12 months | 
| Long term pain relief | Pain relief was assessed using a verbal rating pain change score (VRCS) | 12 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | QOL was assessed using the Short Form 36 | 12 months and 12 year | 
| Complications of treatment |  | 12 year | 
| Analgesic intake |  | 12 months and 12 year | 
| additional surgery because of persisting abdominal pain | patient questionnaire, patients medical record | 12 months and 12 year | 
| rate of consulting medical doctors |  | 12 months and 12 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic abdominal pain, laparoscopic adhesiolysis, placebo