Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain
Primary Purpose
Chronic Pain, Adhesions
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Laparoscopic adhesiolysis
Diagnostic laparoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring chronic abdominal pain, laparoscopic adhesiolysis, placebo
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Adhesiolysis group
Placebo group
Arm Description
Patients underwent laparoscopic adhesiolysis
Patients underwent diagnostic laparoscopy alone
Outcomes
Primary Outcome Measures
Short term pain relief
Pain relief was assessed using a verbal rating pain change score (VRCS)
Long term pain relief
Pain relief was assessed using a verbal rating pain change score (VRCS)
Secondary Outcome Measures
Quality of life
QOL was assessed using the Short Form 36
Complications of treatment
Analgesic intake
additional surgery because of persisting abdominal pain
patient questionnaire, patients medical record
rate of consulting medical doctors
Full Information
NCT ID
NCT02839564
First Posted
July 14, 2016
Last Updated
July 18, 2016
Sponsor
Groene Hart Ziekenhuis
Collaborators
Erasmus Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Rijnstate Hospital, Maxima Medical Center, Catharina Ziekenhuis Eindhoven, Maasstad Hospital, Isala
1. Study Identification
Unique Protocol Identification Number
NCT02839564
Brief Title
Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain
Official Title
Benefit of Laparoscopic Adhesiolysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 1997 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groene Hart Ziekenhuis
Collaborators
Erasmus Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Rijnstate Hospital, Maxima Medical Center, Catharina Ziekenhuis Eindhoven, Maasstad Hospital, Isala
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Adhesions
Keywords
chronic abdominal pain, laparoscopic adhesiolysis, placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adhesiolysis group
Arm Type
Experimental
Arm Description
Patients underwent laparoscopic adhesiolysis
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients underwent diagnostic laparoscopy alone
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic adhesiolysis
Intervention Description
After diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed
Intervention Type
Procedure
Intervention Name(s)
Diagnostic laparoscopy
Intervention Description
After diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped.
Primary Outcome Measure Information:
Title
Short term pain relief
Description
Pain relief was assessed using a verbal rating pain change score (VRCS)
Time Frame
12 months
Title
Long term pain relief
Description
Pain relief was assessed using a verbal rating pain change score (VRCS)
Time Frame
12 year
Secondary Outcome Measure Information:
Title
Quality of life
Description
QOL was assessed using the Short Form 36
Time Frame
12 months and 12 year
Title
Complications of treatment
Time Frame
12 year
Title
Analgesic intake
Time Frame
12 months and 12 year
Title
additional surgery because of persisting abdominal pain
Description
patient questionnaire, patients medical record
Time Frame
12 months and 12 year
Title
rate of consulting medical doctors
Time Frame
12 months and 12 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dingeman Swank, Dr
Organizational Affiliation
Groene Hart Ziekenhuis
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12699951
Citation
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. Erratum In: Lancet. 2003 Jun;361(9376):2250.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://gmail.com
Available IPD/Information Comments
Study data can be requested by mailing to mjmolegraaf@gmail.com
Learn more about this trial
Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain
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