<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/NCT03786159</url>
  </required_header>
  <id_info>
    <org_study_id>SnapshotASBO</org_study_id>
    <nct_id>NCT03786159</nct_id>
  </id_info>
  <brief_title>National Snapshot Study Adhesive Small Bowel Obstruction (ASBO)</brief_title>
  <official_title>Prospective Nationwide Audit of the Management of Adhesive Small Bowel Obstruction: a Snapshot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over 63-90% of patients develop peritoneal adhesions after abdominal or pelvic surgery. Which&#xD;
      makes it the most common complication after abdominal or pelvic surgery. Adhesions comprise a&#xD;
      lifelong risk of adhesion related complications.The most frequent emergency complication of&#xD;
      adhesion is an episode of adhesive small bowel obstruction (ASBO). Over 1 in 5 patients&#xD;
      experiences at least 1 episode of ASBO in the 10 years following initial abdominal surgery.&#xD;
      Despite the high incidence of ASBO, diagnosis and treatment of an episode of ASBO varies&#xD;
      greatly between hospitals and even between doctors. Until now, optimal treatment patterns are&#xD;
      unknown. The aim of this study is mapping of care for patients with a suspected episode of&#xD;
      ASBO. With the collected data new hypothesis will be generated for the ideal diagnostic and&#xD;
      therapeutic workflow for patients with a suspicion of an episode of ASBO.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>CT treatment ASBO</measure>
    <time_frame>February 2021</time_frame>
    <description>In how many patients does CT-scan impact initial management of ASBO (i.e. different cause of SBO found, or conservative trial vs. direct surgery)?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostics ASBO</measure>
    <time_frame>February 2021</time_frame>
    <description>How many patients in the Netherlands presenting with adhesive small bowel obstruction have a CT-scan in their diagnostic work-up?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timeframe conservative trial ASBO</measure>
    <time_frame>February 2021</time_frame>
    <description>How long do Dutch surgeons continue a conservative trial in patients with persistent obstruction who are not clinically deteriorating? Outcome measures will be based on data from the online Case Report Form (CRF).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Conservative trial &gt; 72 hours ASBO</measure>
    <time_frame>February 2021</time_frame>
    <description>Does continuing a conservative trial for more than 72 hours adverse impact final outcomes? Complications as measured by Clavien-Dindo will be registered and compared between groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laparoscopic surgery for ASBO</measure>
    <time_frame>February 2021</time_frame>
    <description>How many patients that are surgically treated for ASBO in the Netherlands have laparoscopic surgery?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Outcome laparoscopic surgery for ASBO</measure>
    <time_frame>February 2021</time_frame>
    <description>What are the outcomes of laparoscopic surgery for ASBO? Days of in hospital stay, postoperative complications (Clavien-Dindo) and 90-day readmissions rates will be compared between patients who underwent open or laparoscopic surgery for ASBO.</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Surgery-Induced Tissue Adhesion</condition>
  <condition>Surgical Adhesions</condition>
  <condition>Adhesion, Tissue</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with a suspicion of ASBO, older than 17 years, can be included in the present&#xD;
        snapshot study. Patients with an episode of small bowel obstruction that is certainly not&#xD;
        caused by adhesions fall outside of the scope of this study (eg. tumor as cause of SBO).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspicion ASBO&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clear other cause of small bowel obstruction (e.g. tumor, hernia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Richard PG ten Broek, PhD, MD</last_name>
    <role>Study Director</role>
    <affiliation>Radboudumc, departement of surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pepijn Krielen, MD</last_name>
    <phone>0243613808</phone>
    <email>pepijn.krielen@radboudumc.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6500HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pepijn Krielen</last_name>
      <email>pepijn.krielen@radboudumc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Ellis H, Moran BJ, Thompson JN, Parker MC, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Brien F, Buchan S, Crowe AM. Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet. 1999 May 1;353(9163):1476-80. doi: 10.1016/S0140-6736(98)09337-4.</citation>
    <PMID>10232313</PMID>
  </reference>
  <reference>
    <citation>Parker MC, Ellis H, Moran BJ, Thompson JN, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Briena F, Buchan S, Crowe AM. Postoperative adhesions: ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum. 2001 Jun;44(6):822-29; discussion 829-30. doi: 10.1007/BF02234701.</citation>
    <PMID>11391142</PMID>
  </reference>
  <reference>
    <citation>Luijendijk RW, de Lange DC, Wauters CC, Hop WC, Duron JJ, Pailler JL, Camprodon BR, Holmdahl L, van Geldorp HJ, Jeekel J. Foreign material in postoperative adhesions. Ann Surg. 1996 Mar;223(3):242-8. doi: 10.1097/00000658-199603000-00003.</citation>
    <PMID>8604903</PMID>
  </reference>
  <reference>
    <citation>Menzies D, Ellis H. Intestinal obstruction from adhesions--how big is the problem? Ann R Coll Surg Engl. 1990 Jan;72(1):60-3.</citation>
    <PMID>2301905</PMID>
  </reference>
  <reference>
    <citation>Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update. 2001 Nov-Dec;7(6):567-76. doi: 10.1093/humupd/7.6.567.</citation>
    <PMID>11727865</PMID>
  </reference>
  <reference>
    <citation>Hershlag A, Diamond MP, DeCherney AH. Adhesiolysis. Clin Obstet Gynecol. 1991 Jun;34(2):395-402. doi: 10.1097/00003081-199106000-00023.</citation>
    <PMID>1831077</PMID>
  </reference>
  <reference>
    <citation>Beck DE, Opelka FG, Bailey HR, Rauh SM, Pashos CL. Incidence of small-bowel obstruction and adhesiolysis after open colorectal and general surgery. Dis Colon Rectum. 1999 Feb;42(2):241-8. doi: 10.1007/BF02237135. Erratum In: Dis Colon Rectum 1999 May;42(5):578.</citation>
    <PMID>10211502</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>October 24, 2019</last_update_submitted>
  <last_update_submitted_qc>October 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Obstruction</mesh_term>
    <mesh_term>Tissue Adhesions</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03786159/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03786159
org study id: SnapshotASBO
nct id: NCT03786159
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Over 63-90% of patients develop peritoneal adhesions after abdominal or pelvic surgery. Which
      makes it the most common complication after abdominal or pelvic surgery. Adhesions comprise a
      lifelong risk of adhesion related complications.The most frequent emergency complication of
      adhesion is an episode of adhesive small bowel obstruction (ASBO). Over 1 in 5 patients
      experiences at least 1 episode of ASBO in the 10 years following initial abdominal surgery.
      Despite the high incidence of ASBO, diagnosis and treatment of an episode of ASBO varies
      greatly between hospitals and even between doctors. Until now, optimal treatment patterns are
      unknown. The aim of this study is mapping of care for patients with a suspected episode of
      ASBO. With the collected data new hypothesis will be generated for the ideal diagnostic and
      therapeutic workflow for patients with a suspicion of an episode of ASBO.
observational model: Cohort
time perspective: Prospective
measure: CT treatment ASBO
time frame: February 2021
description: In how many patients does CT-scan impact initial management of ASBO (i.e. different cause of SBO found, or conservative trial vs. direct surgery)?
measure: Diagnostics ASBO
time frame: February 2021
description: How many patients in the Netherlands presenting with adhesive small bowel obstruction have a CT-scan in their diagnostic work-up?
measure: Timeframe conservative trial ASBO
time frame: February 2021
description: How long do Dutch surgeons continue a conservative trial in patients with persistent obstruction who are not clinically deteriorating? Outcome measures will be based on data from the online Case Report Form (CRF).
measure: Conservative trial > 72 hours ASBO
time frame: February 2021
description: Does continuing a conservative trial for more than 72 hours adverse impact final outcomes? Complications as measured by Clavien-Dindo will be registered and compared between groups.
measure: Laparoscopic surgery for ASBO
time frame: February 2021
description: How many patients that are surgically treated for ASBO in the Netherlands have laparoscopic surgery?
measure: Outcome laparoscopic surgery for ASBO
time frame: February 2021
description: What are the outcomes of laparoscopic surgery for ASBO? Days of in hospital stay, postoperative complications (Clavien-Dindo) and 90-day readmissions rates will be compared between patients who underwent open or laparoscopic surgery for ASBO.
intervention type: Other
intervention name: No intervention
description: No intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Richard PG ten Broek, PhD, MD
role: Study Director
affiliation: Radboudumc, departement of surgery
last name: Pepijn Krielen, MD
phone: 0243613808
email: pepijn.krielen@radboudumc.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
citation: Ellis H, Moran BJ, Thompson JN, Parker MC, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Brien F, Buchan S, Crowe AM. Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet. 1999 May 1;353(9163):1476-80. doi: 10.1016/S0140-6736(98)09337-4.
PMID: 10232313
citation: Parker MC, Ellis H, Moran BJ, Thompson JN, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Briena F, Buchan S, Crowe AM. Postoperative adhesions: ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum. 2001 Jun;44(6):822-29; discussion 829-30. doi: 10.1007/BF02234701.
PMID: 11391142
citation: Luijendijk RW, de Lange DC, Wauters CC, Hop WC, Duron JJ, Pailler JL, Camprodon BR, Holmdahl L, van Geldorp HJ, Jeekel J. Foreign material in postoperative adhesions. Ann Surg. 1996 Mar;223(3):242-8. doi: 10.1097/00000658-199603000-00003.
PMID: 8604903
citation: Menzies D, Ellis H. Intestinal obstruction from adhesions--how big is the problem? Ann R Coll Surg Engl. 1990 Jan;72(1):60-3.
PMID: 2301905
citation: Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update. 2001 Nov-Dec;7(6):567-76. doi: 10.1093/humupd/7.6.567.
PMID: 11727865
citation: Hershlag A, Diamond MP, DeCherney AH. Adhesiolysis. Clin Obstet Gynecol. 1991 Jun;34(2):395-402. doi: 10.1097/00003081-199106000-00023.
PMID: 1831077
citation: Beck DE, Opelka FG, Bailey HR, Rauh SM, Pashos CL. Incidence of small-bowel obstruction and adhesiolysis after open colorectal and general surgery. Dis Colon Rectum. 1999 Feb;42(2):241-8. doi: 10.1007/BF02237135. Erratum In: Dis Colon Rectum 1999 May;42(5):578.
PMID: 10211502
responsible party type: Sponsor
mesh term: Intestinal Obstruction
mesh term: Tissue Adhesions
sharing ipd: Undecided
provided document: 