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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
Groene Hart Ziekenhuis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic abdominal pain, laparoscopic adhesiolysis, placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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

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    Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain

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