<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02983916</url>
  </required_header>
  <id_info>
    <org_study_id>RU-RTB-0005</org_study_id>
    <nct_id>NCT02983916</nct_id>
  </id_info>
  <brief_title>Laparoscopic Adhesiolysis for Chronic Abdominal Pain Revisited</brief_title>
  <official_title>Laparoscopic Adhesiolysis for Chronic Abdominal Pain Revisited</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rijnstate Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic abdominal and pelvic pain is a common complaint following peritoneal surgery,&#xD;
      affecting 20-40% of patients. Adhesions account for 60% of chronic postoperative pain cases,&#xD;
      suggesting that adhesiolysis can play an important role in the management of such pain.&#xD;
      Despite initial promising results regarding the effect of adhesiolysis on post-operative&#xD;
      pain, implementation of the procedure has been challenging. The major problems associated&#xD;
      with adhesiolysis for pain are recurrence of pain, need for invasive diagnosis with high&#xD;
      rates of 'negative' laparoscopies, and inadvertent bowel injury during surgery. However,&#xD;
      diagnosis and treatment of adhesions may be improved through the use of novel cine-MRI&#xD;
      techniques, and with application of anti-adhesion barriers following adhesiolysis.&#xD;
&#xD;
      In this study the investigators evaluate a new practice-based approach to the problem of&#xD;
      chronic post-operative pain caused by adhesions. This practice-based approach includes use of&#xD;
      a novel imaging technique for adhesions (cine-MRI) and shared decision making. Cine-MRI holds&#xD;
      promise to diagnose and map adhesions. Thus patients with no adhesions, or high risk for&#xD;
      bowel injury, can be waived from surgical treatment. By using anti-adhesion barriers the&#xD;
      investigators attempt to prevent adhesion reformation and improve long-term outcomes of&#xD;
      adhesiolysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic adhesiolysis for chronic abdominal pain revisited.&#xD;
&#xD;
      Background Prevalence of chronic pain following abdominal surgery may be as high as 40%.&#xD;
      Postoperative chronic pain can be caused by various reasons, but adhesions are identified as&#xD;
      the most likely cause in more 60% of cases. Early studies of adhesiolysis reported high&#xD;
      success rates, up to 80%, in patients with no other cause of pain. Nonetheless, adhesiolysis&#xD;
      is now seldom used in the treatment of chronic abdominal pain. Controversy over laparoscopic&#xD;
      adhesiolysis as treatment for abdominal pain was raised by the landmark trial of Swank et al.&#xD;
      In this trial 100 patients were randomized after the diagnosis of adhesions was confirmed&#xD;
      laparoscopy between adhesiolysis or diagnostic laparoscopy alone. In the adhesiolysis group&#xD;
      57% of patients reported long-term pain relief vs. 42% in the diagnostic group; this&#xD;
      difference was not statistically significant. The authors concluded that adhesiolysis was not&#xD;
      effective, and thereafter many surgeons discarded adhesiolysis as treatment for chronic&#xD;
      abdominal pain.&#xD;
&#xD;
      However, there are some important critiques on this trial. First, a type II error by too low&#xD;
      sample size cannot be excluded. Second, some experimental studies indicate that filmy&#xD;
      adhesions, which may be disrupted by pneumoperitoneum in the control patient group, cause&#xD;
      most pain. Third, adhesions might have reformed after adhesiolysis, diminishing long term&#xD;
      effects in the adhesiolysis group. Adhesion formation and reformation can effectively be&#xD;
      reduced by application of an anti-adhesion barrier. Apart from these critiques, there is no&#xD;
      evidence for effective alternative treatments.&#xD;
&#xD;
      Patients with chronic postoperative pain are frequently referred to the outpatient clinical&#xD;
      of the surgery department of the RadboudUMC for expert opinion. Since 2012 the investigators&#xD;
      started a 'patient participation in care' project for this patient group, in which&#xD;
      laparoscopic adhesiolysis was reintroduced as treatment for chronic abdominal in selected&#xD;
      cases. Cine- MRI was used as a novel non-invasive tool to diagnose adhesions, waiving the&#xD;
      need for a negative laparoscopy in patient with other causes for chronic abdominal pain.&#xD;
      Cine- MRI was recently developed as a non-invasive diagnostic tool to detect symptomatic&#xD;
      adhesions, with reported sensitivity between 85%- 89% and specificity between 93%-95%.&#xD;
      Decision for operative treatment was made based on individualized assessment of benefits and&#xD;
      risks based on cine-MRI results in a shared-decision approach. Further, all patients&#xD;
      undergoing adhesiolysis were treated with an anti-adhesion barrier.&#xD;
&#xD;
      Purpose &amp; Research question The aim of this study is to evaluate the results of this novel&#xD;
      shared decision approach using cine-MRI in a cohort of patients referred to the outpatient&#xD;
      clinical of the department of surgery with chronic postoperative pain. Comparison is made&#xD;
      between patients undergoing laparoscopic adhesiolysis, patients conservatively treated with&#xD;
      adhesions on cine-MRI, and patients with no adhesions on cine-MRI.&#xD;
&#xD;
      Patients: Patients with chronic postoperative pain (&gt;6 months) caused by adhesions as proven&#xD;
      by cine-MRI Intervention: Laparoscopic adhesiolysis with adhesion barrier Controls: - control&#xD;
      group 1: Patients with chronic postoperative pain and cine-MRI proven adhesions who had&#xD;
      conservative treatment - Control group 2 patients with alternative diagnosis who had&#xD;
      conservative treatment Outcome: • Change in symptoms (measured by Patients' Global Impression&#xD;
      of Change scale), current pain (measured by numeric rate scale), Healthcare utilization&#xD;
      (hospital visits, paramedic visits, medication)&#xD;
&#xD;
      Plan of investigation We will perform an analysis in a cohort of approximately 100 patients&#xD;
      who underwent Cine-MRI in the work-up for chronic abdominal pain. Adhesions were identified&#xD;
      in approximately 80 of the patients, 40 of them were operated and underwent laparoscopic&#xD;
      adhesiolysis (group 1). The other 40 patients waived operation for various reasons and&#xD;
      received conservative treatment (group 2). Patients with negative cine-MRI are analyzed as&#xD;
      group 3. In a few cases a diagnostic laparoscopy was performed in case history, physical&#xD;
      examination and cine-MRI were inconclusive. These patients will be analyzed as part of group&#xD;
      1.&#xD;
&#xD;
      Patients will be asked to participate in this study by telephone or letter. If agreed, a&#xD;
      questionnaire will be sent comparing pain, improvement of pain since treatment, use of&#xD;
      analgesics and other healthcare utilization between the operated and non-operated groups.&#xD;
      Further data on the operation and peri-operative complications are gathered from the case&#xD;
      records. Primary outcome is reduction or alleviation of pain. Secondary outcomes are current&#xD;
      pain score (measured by VAS), analgesics use and healthcare utilization. Additional secondary&#xD;
      outcomes for the operatively treated group are the incidence of conversion to open surgery,&#xD;
      and peri-operative complications.&#xD;
&#xD;
      Patients admitted to the outpatient clinic of the department of surgery for chronic&#xD;
      postoperative pain who underwent a cine-MRI are screened for eligibility.&#xD;
&#xD;
      Inclusion criteria are :&#xD;
&#xD;
        -  Age ≥ 18 years&#xD;
&#xD;
        -  Pain exists for at least 6 months postoperatively&#xD;
&#xD;
      Exclusion criteria are:&#xD;
&#xD;
      - Cine-MRI not performed for chronic pain (e.g. recurrent pain with episodes of bowel&#xD;
      obstructions)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain</measure>
    <time_frame>long-term &gt;6 months to 3 years following surgery or cineMRI</time_frame>
    <description>measured by a verbal rating pain change scale (VRCS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Current pain</measure>
    <time_frame>long-term &gt;6 months to 3 years following surgery or cineMRI</time_frame>
    <description>measured by visual analogue scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of pain</measure>
    <time_frame>long-term &gt;6 months to 3 years following surgery or cineMRI</time_frame>
    <description>measured by a questionnaire using a seven-point Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily discomfort</measure>
    <time_frame>long-term &gt;6 months to 3 years following surgery or cineMRI</time_frame>
    <description>measured by a questionnaire using a seven-point Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization</measure>
    <time_frame>long-term &gt;6 months to 3 years following surgery or cineMRI</time_frame>
    <description>measured by the number of visits to the general practitioner, medical specialist, paramedics and complementary practitioners</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of surgery/ adhesiolysis</measure>
    <time_frame>Peri-operative (up to 30 days after adhesiolysis)</time_frame>
    <description>registered and graded according to the Clavien-Dindo classification. Complications scored as Clavien-Dindo grade 3 or higher were considered severe complications.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">106</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Tissue Adhesion</condition>
  <arm_group>
    <arm_group_label>Group 1: adhesiolysis</arm_group_label>
    <description>Group 1 (the operative group) consisted of all patients who underwent laparoscopy and/or laparotomy. Typically patients had positive cine-MRI. A few patients with inconclusive cine-MRI who underwent diagnostic laparoscopy are also included in this group. Patients with no adhesions found during operation remain in group 1, because analysis is performed on intention-to-treat basis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Adhesions, conservative</arm_group_label>
    <description>Patients with evidence of adhesions based on cine-MRI who did not undergo laparoscopy or laparotomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: No adhesions</arm_group_label>
    <description>Patients in whom no evidence of adhesions was found on cine-MRI, and who did not undergo laparoscopy or laparotomy .</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adhesiolysis</intervention_name>
    <description>Diagnostic laparoscopy or laparotomy with lysis of adhesions.</description>
    <arm_group_label>Group 1: adhesiolysis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the outpatient clinic of the department of surgery for chronic&#xD;
        postoperative pain who underwent a cine-MRI are screened for eligibility.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria are :&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Pain exists for at least 6 months postoperatively&#xD;
&#xD;
        Exclusion criteria are:&#xD;
&#xD;
        - Cine-MRI not performed for chronic pain (e.g. recurrent pain with episodes of bowel&#xD;
        obstructions)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harry van Goor, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <state>Gelderland</state>
        <zip>6800TA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>ten Broek RP, Bakkum EA, Laarhoven CJ, van Goor H. Epidemiology and Prevention of Postsurgical Adhesions Revisited. Ann Surg. 2016 Jan;263(1):12-9. doi: 10.1097/SLA.0000000000001286.</citation>
    <PMID>26135678</PMID>
  </reference>
  <reference>
    <citation>Ten Broek RPG, Stommel MWJ, Strik C, van Laarhoven CJHM, Keus F, van Goor H. Benefits and harms of adhesion barriers for abdominal surgery: a systematic review and meta-analysis. Lancet. 2014 Jan 4;383(9911):48-59. doi: 10.1016/S0140-6736(13)61687-6. Epub 2013 Sep 27.</citation>
    <PMID>24075279</PMID>
  </reference>
  <reference>
    <citation>Gerner-Rasmussen J, Burcharth J, Gogenur I. The efficacy of adhesiolysis on chronic abdominal pain: a systematic review. Langenbecks Arch Surg. 2015 Jul;400(5):567-76. doi: 10.1007/s00423-015-1316-9. Epub 2015 Jun 20.</citation>
    <PMID>26088873</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>12699951</PMID>
  </reference>
  <reference>
    <citation>Cheong YC, Reading I, Bailey S, Sadek K, Ledger W, Li TC. Should women with chronic pelvic pain have adhesiolysis? BMC Womens Health. 2014 Mar 4;14(1):36. doi: 10.1186/1472-6874-14-36.</citation>
    <PMID>24588989</PMID>
  </reference>
  <results_reference>
    <citation>van den Beukel BAW, Stommel MWJ, van Leuven S, Strik C, IJsseldijk MA, Joosten F, van Goor H, Ten Broek RPG. A Shared Decision Approach to Chronic Abdominal Pain Based on Cine-MRI: A Prospective Cohort Study. Am J Gastroenterol. 2018 Aug;113(8):1229-1237. doi: 10.1038/s41395-018-0158-9. Epub 2018 Jun 27.</citation>
    <PMID>29946174</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>May 1, 2019</last_update_submitted>
  <last_update_submitted_qc>May 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adhesions</keyword>
  <keyword>Adhesiolysis</keyword>
  <keyword>chronic pain</keyword>
  <keyword>post-operative complications</keyword>
  <keyword>anti-adhesion barrier</keyword>
  <keyword>cine-MRI</keyword>
  <keyword>shared decision making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Tissue Adhesions</mesh_term>
    <mesh_term>Abdominal Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Individual patient data will be made available for future research upon reasonable request</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://doi.org/10.1038/s41395-018-0158-9</doc_url>
    </study_doc>
  </study_docs>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02983916
org study id: RU-RTB-0005
nct id: NCT02983916
lead sponsor: 
collaborator: 
has dmc: No
Chronic abdominal and pelvic pain is a common complaint following peritoneal surgery,
      affecting 20-40% of patients. Adhesions account for 60% of chronic postoperative pain cases,
      suggesting that adhesiolysis can play an important role in the management of such pain.
      Despite initial promising results regarding the effect of adhesiolysis on post-operative
      pain, implementation of the procedure has been challenging. The major problems associated
      with adhesiolysis for pain are recurrence of pain, need for invasive diagnosis with high
      rates of 'negative' laparoscopies, and inadvertent bowel injury during surgery. However,
      diagnosis and treatment of adhesions may be improved through the use of novel cine-MRI
      techniques, and with application of anti-adhesion barriers following adhesiolysis.

      In this study the investigators evaluate a new practice-based approach to the problem of
      chronic post-operative pain caused by adhesions. This practice-based approach includes use of
      a novel imaging technique for adhesions (cine-MRI) and shared decision making. Cine-MRI holds
      promise to diagnose and map adhesions. Thus patients with no adhesions, or high risk for
      bowel injury, can be waived from surgical treatment. By using anti-adhesion barriers the
      investigators attempt to prevent adhesion reformation and improve long-term outcomes of
      adhesiolysis.
Laparoscopic adhesiolysis for chronic abdominal pain revisited.

      Background Prevalence of chronic pain following abdominal surgery may be as high as 40%.
      Postoperative chronic pain can be caused by various reasons, but adhesions are identified as
      the most likely cause in more 60% of cases. Early studies of adhesiolysis reported high
      success rates, up to 80%, in patients with no other cause of pain. Nonetheless, adhesiolysis
      is now seldom used in the treatment of chronic abdominal pain. Controversy over laparoscopic
      adhesiolysis as treatment for abdominal pain was raised by the landmark trial of Swank et al.
      In this trial 100 patients were randomized after the diagnosis of adhesions was confirmed
      laparoscopy between adhesiolysis or diagnostic laparoscopy alone. In the adhesiolysis group
      57% of patients reported long-term pain relief vs. 42% in the diagnostic group; this
      difference was not statistically significant. The authors concluded that adhesiolysis was not
      effective, and thereafter many surgeons discarded adhesiolysis as treatment for chronic
      abdominal pain.

      However, there are some important critiques on this trial. First, a type II error by too low
      sample size cannot be excluded. Second, some experimental studies indicate that filmy
      adhesions, which may be disrupted by pneumoperitoneum in the control patient group, cause
      most pain. Third, adhesions might have reformed after adhesiolysis, diminishing long term
      effects in the adhesiolysis group. Adhesion formation and reformation can effectively be
      reduced by application of an anti-adhesion barrier. Apart from these critiques, there is no
      evidence for effective alternative treatments.

      Patients with chronic postoperative pain are frequently referred to the outpatient clinical
      of the surgery department of the RadboudUMC for expert opinion. Since 2012 the investigators
      started a 'patient participation in care' project for this patient group, in which
      laparoscopic adhesiolysis was reintroduced as treatment for chronic abdominal in selected
      cases. Cine- MRI was used as a novel non-invasive tool to diagnose adhesions, waiving the
      need for a negative laparoscopy in patient with other causes for chronic abdominal pain.
      Cine- MRI was recently developed as a non-invasive diagnostic tool to detect symptomatic
      adhesions, with reported sensitivity between 85%- 89% and specificity between 93%-95%.
      Decision for operative treatment was made based on individualized assessment of benefits and
      risks based on cine-MRI results in a shared-decision approach. Further, all patients
      undergoing adhesiolysis were treated with an anti-adhesion barrier.

      Purpose & Research question The aim of this study is to evaluate the results of this novel
      shared decision approach using cine-MRI in a cohort of patients referred to the outpatient
      clinical of the department of surgery with chronic postoperative pain. Comparison is made
      between patients undergoing laparoscopic adhesiolysis, patients conservatively treated with
      adhesions on cine-MRI, and patients with no adhesions on cine-MRI.

      Patients: Patients with chronic postoperative pain (>6 months) caused by adhesions as proven
      by cine-MRI Intervention: Laparoscopic adhesiolysis with adhesion barrier Controls: - control
      group 1: Patients with chronic postoperative pain and cine-MRI proven adhesions who had
      conservative treatment - Control group 2 patients with alternative diagnosis who had
      conservative treatment Outcome: • Change in symptoms (measured by Patients' Global Impression
      of Change scale), current pain (measured by numeric rate scale), Healthcare utilization
      (hospital visits, paramedic visits, medication)

      Plan of investigation We will perform an analysis in a cohort of approximately 100 patients
      who underwent Cine-MRI in the work-up for chronic abdominal pain. Adhesions were identified
      in approximately 80 of the patients, 40 of them were operated and underwent laparoscopic
      adhesiolysis (group 1). The other 40 patients waived operation for various reasons and
      received conservative treatment (group 2). Patients with negative cine-MRI are analyzed as
      group 3. In a few cases a diagnostic laparoscopy was performed in case history, physical
      examination and cine-MRI were inconclusive. These patients will be analyzed as part of group
      1.

      Patients will be asked to participate in this study by telephone or letter. If agreed, a
      questionnaire will be sent comparing pain, improvement of pain since treatment, use of
      analgesics and other healthcare utilization between the operated and non-operated groups.
      Further data on the operation and peri-operative complications are gathered from the case
      records. Primary outcome is reduction or alleviation of pain. Secondary outcomes are current
      pain score (measured by VAS), analgesics use and healthcare utilization. Additional secondary
      outcomes for the operatively treated group are the incidence of conversion to open surgery,
      and peri-operative complications.

      Patients admitted to the outpatient clinic of the department of surgery for chronic
      postoperative pain who underwent a cine-MRI are screened for eligibility.

      Inclusion criteria are :

        -  Age ≥ 18 years

        -  Pain exists for at least 6 months postoperatively

      Exclusion criteria are:

      - Cine-MRI not performed for chronic pain (e.g. recurrent pain with episodes of bowel
      obstructions)
observational model: Cohort
time perspective: Prospective
measure: Change in pain
time frame: long-term >6 months to 3 years following surgery or cineMRI
description: measured by a verbal rating pain change scale (VRCS)
measure: Current pain
time frame: long-term >6 months to 3 years following surgery or cineMRI
description: measured by visual analogue scale (VAS)
measure: Frequency of pain
time frame: long-term >6 months to 3 years following surgery or cineMRI
description: measured by a questionnaire using a seven-point Likert scale
measure: Daily discomfort
time frame: long-term >6 months to 3 years following surgery or cineMRI
description: measured by a questionnaire using a seven-point Likert scale
measure: Healthcare utilization
time frame: long-term >6 months to 3 years following surgery or cineMRI
description: measured by the number of visits to the general practitioner, medical specialist, paramedics and complementary practitioners
measure: Complications of surgery/ adhesiolysis
time frame: Peri-operative (up to 30 days after adhesiolysis)
description: registered and graded according to the Clavien-Dindo classification. Complications scored as Clavien-Dindo grade 3 or higher were considered severe complications.
arm group label: Group 1: adhesiolysis
description: Group 1 (the operative group) consisted of all patients who underwent laparoscopy and/or laparotomy. Typically patients had positive cine-MRI. A few patients with inconclusive cine-MRI who underwent diagnostic laparoscopy are also included in this group. Patients with no adhesions found during operation remain in group 1, because analysis is performed on intention-to-treat basis.
arm group label: Group 2: Adhesions, conservative
description: Patients with evidence of adhesions based on cine-MRI who did not undergo laparoscopy or laparotomy.
arm group label: Group 3: No adhesions
description: Patients in whom no evidence of adhesions was found on cine-MRI, and who did not undergo laparoscopy or laparotomy .
intervention type: Procedure
intervention name: Adhesiolysis
description: Diagnostic laparoscopy or laparotomy with lysis of adhesions.
arm group label: Group 1: adhesiolysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harry van Goor, MD, PhD
role: Principal Investigator
affiliation: Radboud University Medical Center
facility: 
country: Netherlands
citation: ten Broek RP, Bakkum EA, Laarhoven CJ, van Goor H. Epidemiology and Prevention of Postsurgical Adhesions Revisited. Ann Surg. 2016 Jan;263(1):12-9. doi: 10.1097/SLA.0000000000001286.
PMID: 26135678
citation: Ten Broek RPG, Stommel MWJ, Strik C, van Laarhoven CJHM, Keus F, van Goor H. Benefits and harms of adhesion barriers for abdominal surgery: a systematic review and meta-analysis. Lancet. 2014 Jan 4;383(9911):48-59. doi: 10.1016/S0140-6736(13)61687-6. Epub 2013 Sep 27.
PMID: 24075279
citation: Gerner-Rasmussen J, Burcharth J, Gogenur I. The efficacy of adhesiolysis on chronic abdominal pain: a systematic review. Langenbecks Arch Surg. 2015 Jul;400(5):567-76. doi: 10.1007/s00423-015-1316-9. Epub 2015 Jun 20.
PMID: 26088873
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.
PMID: 12699951
citation: Cheong YC, Reading I, Bailey S, Sadek K, Ledger W, Li TC. Should women with chronic pelvic pain have adhesiolysis? BMC Womens Health. 2014 Mar 4;14(1):36. doi: 10.1186/1472-6874-14-36.
PMID: 24588989
citation: van den Beukel BAW, Stommel MWJ, van Leuven S, Strik C, IJsseldijk MA, Joosten F, van Goor H, Ten Broek RPG. A Shared Decision Approach to Chronic Abdominal Pain Based on Cine-MRI: A Prospective Cohort Study. Am J Gastroenterol. 2018 Aug;113(8):1229-1237. doi: 10.1038/s41395-018-0158-9. Epub 2018 Jun 27.
PMID: 29946174
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Tissue Adhesions
mesh term: Abdominal Pain
sharing ipd: Undecided
ipd description: Individual patient data will be made available for future research upon reasonable request
study doc: 