<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/NCT02991287</url>
  </required_header>
  <id_info>
    <org_study_id>PI16/00279</org_study_id>
    <nct_id>NCT02991287</nct_id>
  </id_info>
  <brief_title>Validation of Predictive Scale of Chronic Postsurgical Pain</brief_title>
  <official_title>Prospective External Validation of a Predictive Scale of Chronic Postsurgical Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parc de Salut Mar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Parc de Salut Mar</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To asses the precision of a score to predict chronic post surgical pain in patients&#xD;
      undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and&#xD;
      thoracotomy. Prospective multicenter cohort study in 21 hospital in spain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</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>GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12).</measure>
    <time_frame>After evaluation of chronic postsurgical pain 4th month after the end of surgery</time_frame>
    <description>GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12) to identify patients that could develop chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Verbal rating scale</measure>
    <time_frame>After evaluation of chronic postsurgical pain 4th month after the end of surgery</time_frame>
    <description>Prevalence of chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy will be assessed by verbal rating scale.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1040</enrollment>
  <condition>Chronic Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Chronic post-surgical pain patients</arm_group_label>
    <description>Patients scheduled for differents types of surgery (inguinal, hernia repair, abdominal hysterectomy, vaginal hysterectomy, and thoracotomy).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Inguinal hernia repair</intervention_name>
    <arm_group_label>Chronic post-surgical pain patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Abdominal hysterectomy</intervention_name>
    <arm_group_label>Chronic post-surgical pain patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vaginal hysterectomy</intervention_name>
    <arm_group_label>Chronic post-surgical pain patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thoracotomy</intervention_name>
    <arm_group_label>Chronic post-surgical pain patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All spanish patients who undergo scheduled surgery of one of the following types:&#xD;
&#xD;
        inguinal herniorrhaphy, abdominal hysterectomy, vaginal hysterectomy, thoracotomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with given inform consent, aged mor than 18 years, who undergo scheduled&#xD;
             surgery of one of the following types: inguinal hernia (men), abdominal hysterectomy,&#xD;
             vaginal hysterectomy and thoracotomy (men)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged less than 18 years,&#xD;
&#xD;
          -  Patients requiring reoperation because of surgical complications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Antonio Montes, PhD</last_name>
    <phone>0034932483000</phone>
    <email>amontes@parcdesalutmar.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital de Badalona</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08911</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Dolors Sintes, PhD</last_name>
      <phone>0034934648447</phone>
      <email>dsintes@bsa.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Tries i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Gisela Roca, PhD</last_name>
      <phone>0034639111869</phone>
    </contact>
    <contact_backup>
      <email>giselaroca@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hospital de Bellvitge</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Ancor Serrano, PhD</last_name>
      <phone>00342607323</phone>
      <email>a.serrano@bellvitgehospital.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Mataró</name>
      <address>
        <city>Mataro</city>
        <state>Barcelona</state>
        <zip>08304</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Paloma Ricós, PhD</last_name>
      <phone>0034629957578</phone>
      <email>paloma.ricos@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Parc Taulí</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Josep Troy, PhD</last_name>
      <phone>0034649954375</phone>
      <email>morphicman@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona</state>
        <zip>08227</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Carmen Martin Pardo, PhD</last_name>
      <phone>0034655696311</phone>
      <email>cmartin@cst.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Cruces</name>
      <address>
        <city>Baracaldo</city>
        <state>Bizcaia</state>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Alberto Martínez, PhD</last_name>
      <phone>0034946006000</phone>
      <email>alberto.martinezruiz@osakidetza.eus</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Palma</state>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Hermann Ribera, PhD</last_name>
      <phone>0034652688385</phone>
      <email>h.ribera@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Son Llatzer</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Palma</state>
        <zip>07198</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Jose Luis Aguilar, PhD</last_name>
      <phone>0034670058182</phone>
      <email>15049jas@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital General de Alicante</name>
      <address>
        <city>Alicante</city>
        <state>Valencia</state>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Ana Peiró, PhD</last_name>
      <phone>0034605861967</phone>
      <email>peiro.anamaria@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Antonio Montes, PhD</last_name>
      <phone>0034932483350</phone>
      <email>AMontes@parcdesalutmar.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Miren Revuelta, PhD</last_name>
      <phone>0034935565836</phone>
      <email>mrevuelta@santpau.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de la Vall d'Hebrón</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Angela Mesas, PhD</last_name>
      <phone>0034649483472</phone>
      <email>amesas@vhebron.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Rafael</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>José Luís Casbas, PhD</last_name>
      <phone>0034932112508</phone>
      <email>jlcasbas.hsrafael@hospitalarias.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Galdakao</name>
      <address>
        <city>Bizkaia</city>
        <zip>48960</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Sonia Latorre Esteban, PhD</last_name>
      <phone>0034675711390</phone>
      <email>sonia.latorreesteban@osakidetza.eus</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopsital Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Carmen Benito Alcala, PhD</last_name>
      <phone>0034638210787</phone>
      <email>mbeniro.hgugm@salud.madrid.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Raquel Saldaña Casado, PhD</last_name>
      <phone>0034629768968</phone>
      <email>rasalca@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Nuestra Señora de Valme</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Fernando Caba Rabientos, PhD</last_name>
      <phone>0034955 01 50 00</phone>
      <email>fcababarrientos@terra.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Javier Dese, PhD</last_name>
      <phone>0034625471540</phone>
      <email>javierdese@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Lluís Alcanyís de Xàtiva</name>
      <address>
        <city>Valencia</city>
        <zip>46800</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Vicente Domingo, PhD</last_name>
      <phone>0034610550892</phone>
      <email>domingo_vic@gva.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <zip>47003</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Maria Asunción Pérez Herrero, PhD</last_name>
      <phone>0034630750263</phone>
      <email>aperezh@saludcastillayleon.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 9, 2016</last_update_submitted>
  <last_update_submitted_qc>December 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Parc de Salut Mar</investigator_affiliation>
    <investigator_full_name>Antonio Montes</investigator_full_name>
    <investigator_title>Anesthesiologyst, PhD.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <!-- 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/NCT02991287
org study id: PI16/00279
nct id: NCT02991287
lead sponsor: 
has dmc: No
To asses the precision of a score to predict chronic post surgical pain in patients
      undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and
      thoracotomy. Prospective multicenter cohort study in 21 hospital in spain.
observational model: Cohort
time perspective: Prospective
measure: GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12).
time frame: After evaluation of chronic postsurgical pain 4th month after the end of surgery
description: GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12) to identify patients that could develop chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy.
measure: Verbal rating scale
time frame: After evaluation of chronic postsurgical pain 4th month after the end of surgery
description: Prevalence of chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy will be assessed by verbal rating scale.
arm group label: Chronic post-surgical pain patients
description: Patients scheduled for differents types of surgery (inguinal, hernia repair, abdominal hysterectomy, vaginal hysterectomy, and thoracotomy).
intervention type: Procedure
intervention name: Inguinal hernia repair
arm group label: Chronic post-surgical pain patients
intervention type: Procedure
intervention name: Abdominal hysterectomy
arm group label: Chronic post-surgical pain patients
intervention type: Procedure
intervention name: Vaginal hysterectomy
arm group label: Chronic post-surgical pain patients
intervention type: Procedure
intervention name: Thoracotomy
arm group label: Chronic post-surgical pain patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Antonio Montes, PhD
phone: 0034932483000
email: amontes@parcdesalutmar.cat
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country: Spain
responsible party type: Principal Investigator
investigator affiliation: Parc de Salut Mar
investigator full name: Antonio Montes
investigator title: Anesthesiologyst, PhD.
mesh term: Pain, Postoperative