Chronic PainPhase 4NCT02839564
Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain
A Phase 4 study testing Laparoscopic adhesiolysis and Diagnostic laparoscopy in people with Chronic Pain and Adhesions, run by Groene Hart Ziekenhuis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Adhesions
- What is being tested?
- Laparoscopic adhesiolysis and Diagnostic laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 1997to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
About this study
Official title: Benefit of Laparoscopic Adhesiolysis
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.
Read the 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.
- Conditions
- Chronic Pain, Adhesions
- Being tested
- Laparoscopic adhesiolysis, Diagnostic laparoscopy
- Keywords
- chronic abdominal pain, laparoscopic adhesiolysis, placebo
- Medical subject headings
- Chronic Pain, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic adhesiolysisProcedure or surgery
After diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed
Diagnostic laparoscopyProcedure or surgery
After diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped.
| Study group | Role | What they receive |
|---|---|---|
| Adhesiolysis group | Experimental | Patients underwent laparoscopic adhesiolysis Receives: Procedure: Laparoscopic adhesiolysis |
| Placebo group | Placebo comparator | Patients underwent diagnostic laparoscopy alone Receives: Procedure: Diagnostic laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term pain relief
Pain relief was assessed using a verbal rating pain change score (VRCS)
Measured: 12 months
Long term pain relief
Pain relief was assessed using a verbal rating pain change score (VRCS)
Measured: 12 year
Secondary outcomes (5)
Quality of life
QOL was assessed using the Short Form 36
Measured: 12 months and 12 year
Complications of treatment
Measured: 12 year
Analgesic intake
Measured: 12 months and 12 year
additional surgery because of persisting abdominal pain
patient questionnaire, patients medical record
Measured: 12 months and 12 year
rate of consulting medical doctors
Measured: 12 months and 12 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startAug 1997
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groene Hart Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Rijnstate Hospital, Maxima Medical Center, Catharina Ziekenhuis Eindhoven, Maasstad Hospital, Isala
- Responsible party
- Principal investigator, Marijke Molegraaf, Groene Hart Ziekenhuis
- Investigators
- Dingeman Swank, Dr, Principal investigator, Groene Hart Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839564
- Sponsor's protocol ID
- 160.613/1997/70
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12699951
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Laparoscopic Adhesiolysis
- ClinicalTrials.gov ID
- NCT02839564
- Acronym / sponsor ID
- 160.613/1997/70
- Conditions
- Chronic Pain, Adhesions
- Keywords
- chronic abdominal pain, laparoscopic adhesiolysis, placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Groene Hart ZiekenhuisUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Rijnstate Hospital, Maxima Medical Center, Catharina Ziekenhuis Eindhoven, Maasstad Hospital, Isala
- Study start
- Aug 1997
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adhesiolysis group | Experimental | Procedure: Laparoscopic adhesiolysisPatients underwent laparoscopic adhesiolysis |
| Placebo group | Placebo comparator | Procedure: Diagnostic laparoscopyPatients underwent diagnostic laparoscopy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic adhesiolysisAfter diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed | Procedure or surgery | Adhesiolysis group |
| Diagnostic laparoscopyAfter diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped. | Procedure or surgery | Placebo group |
Primary outcome
Short term pain relief
Time frame: 12 months
Pain relief was assessed using a verbal rating pain change score (VRCS)
Long term pain relief
Time frame: 12 year
Pain relief was assessed using a verbal rating pain change score (VRCS)
5 secondary outcomes
Quality of life
Time frame: 12 months and 12 year
Complications of treatment
Time frame: 12 year
Analgesic intake
Time frame: 12 months and 12 year
additional surgery because of persisting abdominal pain
Time frame: 12 months and 12 year
rate of consulting medical doctors
Time frame: 12 months and 12 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Results publication: PubMed 12699951Swank 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dingeman Swank, Dr principal investigator
Groene Hart Ziekenhuis
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic adhesiolysis and Diagnostic laparoscopy in people with Chronic Pain and Adhesions, run by Groene Hart Ziekenhuis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term pain relief (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02839564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.