Chronic Pain Clinical Trial
Official title:
Benefit of Laparoscopic Adhesiolysis
Verified date | July 2016 |
Source | Groene Hart Ziekenhuis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Medical Ethics Review Committee (METC) |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Groene Hart Ziekenhuis | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Catharina Ziekenhuis Eindhoven, Erasmus Medical Center, Isala, Maasstad Hospital, Maxima Medical Center, Rijnstate Hospital |
Swank DJ, Swank-Bordewijk SC, Hop WC, van Erp WF, Janssen IM, Bonjer HJ, Jeekel J. Laparoscopic adhesiolysis in patients with chronic abdominal pain: a blinded randomised controlled multi-centre trial. Lancet. 2003 Apr 12;361(9365):1247-51. Erratum in: La — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short term pain relief | Pain relief was assessed using a verbal rating pain change score (VRCS) | 12 months | No |
Primary | Long term pain relief | Pain relief was assessed using a verbal rating pain change score (VRCS) | 12 year | No |
Secondary | Quality of life | QOL was assessed using the Short Form 36 | 12 months and 12 year | No |
Secondary | Complications of treatment | 12 year | Yes | |
Secondary | Analgesic intake | 12 months and 12 year | No | |
Secondary | additional surgery because of persisting abdominal pain | patient questionnaire, patients medical record | 12 months and 12 year | No |
Secondary | rate of consulting medical doctors | 12 months and 12 year | No |
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