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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Rijnstate Hospital | OTHER |
| Maxima Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adhesiolysis group | Experimental | Patients underwent laparoscopic adhesiolysis |
|
| Placebo group | Placebo Comparator | Patients underwent diagnostic laparoscopy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic adhesiolysis | Procedure | After diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed |
|
| 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 |
| 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 | |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dingeman Swank, Dr | Groene Hart Ziekenhuis | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12699951 | Result | 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. doi: 10.1016/s0140-6736(03)12979-0. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Maasstad Hospital | OTHER |
| Isala | OTHER |
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| Diagnostic laparoscopy | Procedure | After diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped. |
|
| 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 |
Study data can be requested by mailing to mjmolegraaf@gmail.com |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |