<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/NCT04481698</url>
  </required_header>
  <id_info>
    <org_study_id>176/2017</org_study_id>
    <nct_id>NCT04481698</nct_id>
  </id_info>
  <brief_title>Mesoglycan for Pain Control After Open Excisional HAEMOrrhoidectomy</brief_title>
  <acronym>MeHAEMO</acronym>
  <official_title>Mesoglycan for Pain Control After Open Excisional HAEMOrrhoidectomy (MeHAEMO): An Observational Multicentre Study on Behalf of the Italian Society of Colorectal Surgery (SICCR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Societa Italiana di Chirurgia ColoRettale</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gaetano Gallo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Giuseppe Sammarco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Giuseppe Clerico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alessandro Sturiale</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Michele Manigrasso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alberto Realis Luc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mario Trompetto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Societa Italiana di Chirurgia ColoRettale</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>
      Haemorrhoidal disease (HD) is the most common proctological disease, with a prevalence that&#xD;
      can reach up to 39% of the population. Although I and II degree HD can be treated&#xD;
      successfully with medical therapy or office-based procedures , excisional haemorrhoidectomy&#xD;
      remains the gold standard technique in patients with III and IV degree HD, obtaining a much&#xD;
      lower rate of recurrence than non-excisional methods, such as Doppler-guided haemorrhoidal&#xD;
      artery ligation or stapled haemorrhoidopexy. However, both open and closed&#xD;
      haemorrhoidectomies are associated with a significant rate of post-operative pain , which may&#xD;
      be due to the incorporation of sensitive anal mucosa and fibres of the internal sphincters&#xD;
      during the ligation of the vascular pedicle, post-operative scars, hygiene/social habits,&#xD;
      hard stool, or oedema of the necessary mucocutaneous bridge.&#xD;
&#xD;
      Regarding the oedema/thrombosis of the mucocutaneous bridges, we strongly believe that it is&#xD;
      the main cause of post-operative pain, and we have shown that the use of mesoglycan, a&#xD;
      polysaccharide complex with antithrombotic and profibrinolytic properties, can reduce the&#xD;
      rate of post-operative thrombosis and consequently post-operative pain 7-10 days after the&#xD;
      procedures, improving patient quality of life and speeding up the recovery of daily&#xD;
      activities.&#xD;
&#xD;
      Furthermore, its usefulness is also evident in the treatment of the acute phase of external&#xD;
      haemorrhoidal thrombosis.&#xD;
&#xD;
      The aim of the study was to evaluate the efficacy of mesoglycan in the post-operative period&#xD;
      of patients who underwent open excisional diathermy haemorrhoidectomy, confirming the&#xD;
      previously obtained results&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a retrospective multicentre study and is reported according to the Strengthening the&#xD;
      Reporting of Observational Studies in Epidemiology (STROBE) statement for cohort studies&#xD;
&#xD;
      Between September and December 2017, 206 patients with III and IV degree HD, according to&#xD;
      Goligher classification, from sixteen colorectal referral centres belonging to SICCR (Società&#xD;
      Italiana di Chirurgia Colorettale), who satisfied inclusion criteria underwent open excision&#xD;
      haemorrhoidectomy.&#xD;
&#xD;
      The results obtained were compared with a homogeneous sample of 192 patients who underwent&#xD;
      OEH in the same centres between April and July 2017 and who had received standard&#xD;
      post-operative therapy without mesoglycan.&#xD;
&#xD;
      All patients received the standard post-operative therapy (a recommended oral dose of&#xD;
      ketorolac tromethamine of 10 mg every 4-6 hours, not exceeding 40 mg per day and not&#xD;
      exceeding 5 post-operative days according to the indications for short-term management of&#xD;
      moderate/severe acute post-operative pain and stool softeners) plus mesoglycan (Prisma® 30 mg&#xD;
      2 vials i.m./day for the first 5 post-operative days and then Prisma® 50 mg 1 oral tablet&#xD;
      twice/day for an additional 30 days, Mediolanum Farmaceutici, Milan, Italy).&#xD;
&#xD;
      In each referral centre, the procedures were carried out by an experienced surgeon who had&#xD;
      performed more than 200 haemorrhoidectomies.&#xD;
&#xD;
      A clinical external examination was performed the first post-operative day, and an anorectal&#xD;
      digital evaluation with proctoscopy was performed at T2, T3 and T4.&#xD;
&#xD;
      During each follow-up visit, post-operative pain was evaluated at rest, after defecation and&#xD;
      after anorectal digital examination using a visual analogue scale (minimum score = 0; maximum&#xD;
      score = 10).&#xD;
&#xD;
      Quality of life was evaluated pre- and post-operatively 90 days after the procedure using the&#xD;
      SF-12 questionnaire.&#xD;
&#xD;
      Polypharmacy was defined as 5 or more medications daily. Thrombosis was defined as one or&#xD;
      more swollen painful piles at the site of the mucocutaneous bridge and was assessed at T2, T3&#xD;
      and T4.&#xD;
&#xD;
      Surgical wound healing (granulation) was evaluated at T2, T3 and T4 using the following 3&#xD;
      items: infected, granulating, healed.&#xD;
&#xD;
      Autonomy was evaluated at T2, T3 and T4 using the following 4 items: complete inactivity,&#xD;
      total autonomy at home, ability to drive, return to normal activities (autonomy at home,&#xD;
      driving, working).&#xD;
&#xD;
      Bowel movements were evaluated, according to the proper guidelines, at T2, T3 and T4, and&#xD;
      patients were classified in three categories: regular, constipation or diarrhoea.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Post-operative Pain</measure>
    <time_frame>Day 7, Day 20, Day 40</time_frame>
    <description>VAS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in post-operative Thrombosis</measure>
    <time_frame>Day 7, Day 20, Day 40</time_frame>
    <description>Dichotomous parameter (Yes or Not)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in post-operative Bleeding</measure>
    <time_frame>Day 7, Day 20, Day 40</time_frame>
    <description>Dichotomous parameter (Yes or Not)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL)</measure>
    <time_frame>pre- and post-operatively 90 days after the procedure</time_frame>
    <description>We used the 12-Item Short Form Survey (SF-12) to assess QoL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Surgical Wound Healing</measure>
    <time_frame>Day 7, Day 20, Day 40</time_frame>
    <description>we evaluated wound healing with the following scale: infected, granulating, healed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes Autonomy</measure>
    <time_frame>Day 7, Day 20, Day 40</time_frame>
    <description>we evaluated autonomy with the following parameters: complete inactivity (patient unable to performing any activity), total autonomy at home, ability to drive, return to normal activities (patient able to performing any activity)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">398</enrollment>
  <condition>Haemorrhoidal Disease</condition>
  <condition>Post-operative Pain</condition>
  <condition>Thrombosis</condition>
  <arm_group>
    <arm_group_label>Mesoglycan</arm_group_label>
    <description>All patients received the standard post-operative therapy (a recommended oral dose of ketorolac tromethamine of 10 mg every 4-6 hours, not exceeding 40 mg per day and not exceeding 5 post-operative days according to the indications for short-term management of moderate/severe acute post-operative pain and stool softeners) plus mesoglycan (Prisma® 30 mg 2 vials i.m./day for the first 5 post-operative days and then Prisma® 50 mg 1 oral tablet twice/day for an additional 30 days, Mediolanum Farmaceutici, Milan, Italy)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>standard post-operative therapy (a recommended oral dose of ketorolac tromethamine of 10 mg every 4-6 hours, not exceeding 40 mg per day and not exceeding 5 post-operative days according to the indications for short-term management of moderate/severe acute post-operative pain and stool softeners)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mesoglycan</intervention_name>
    <description>Prisma® 30 mg 2 vials i.m./day for the first 5 post-operative days and then Prisma® 50 mg 1 oral tablet twice/day for an additional 30 days</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Mesoglycan</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients received the standard post-operative therapy (a recommended oral dose of&#xD;
        ketorolac tromethamine of 10 mg every 4-6 hours, not exceeding 40 mg per day and not&#xD;
        exceeding 5 post-operative days according to the indications for short-term management of&#xD;
        moderate/severe acute post-operative pain and stool softeners) plus mesoglycan (Prisma® 30&#xD;
        mg 2 vials i.m./day for the first 5 post-operative days and then Prisma® 50 mg 1 oral&#xD;
        tablet twice/day for an additional 30 days, Mediolanum Farmaceutici, Milan, Italy).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  III and IV degree Hemorrhoidal Disease&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  Written Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18&#xD;
&#xD;
          -  Past or present history of:&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Cardiac Diseases&#xD;
&#xD;
          -  Anticoagulant Therapies&#xD;
&#xD;
          -  Colorectal or Anal Neoplasms&#xD;
&#xD;
          -  Inflammatory Bowel Disease&#xD;
&#xD;
          -  Pelvic Radiotherapy&#xD;
&#xD;
          -  Anal Surgery&#xD;
&#xD;
          -  Allergy to Mesoglycan&#xD;
&#xD;
          -  Inability to return for post-operative control visits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>University of Catanzaro</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Gallo G, Martellucci J, Sturiale A, Clerico G, Milito G, Marino F, Cocorullo G, Giordano P, Mistrangelo M, Trompetto M. Consensus statement of the Italian society of colorectal surgery (SICCR): management and treatment of hemorrhoidal disease. Tech Coloproctol. 2020 Feb;24(2):145-164. doi: 10.1007/s10151-020-02149-1. Epub 2020 Jan 28.</citation>
    <PMID>31993837</PMID>
  </results_reference>
  <results_reference>
    <citation>Cocorullo G, Tutino R, Falco N, Licari L, Orlando G, Fontana T, Raspanti C, Salamone G, Scerrino G, Gallo G, Trompetto M, Gulotta G. The non-surgical management for hemorrhoidal disease. A systematic review. G Chir. 2017 Jan-Feb;38(1):5-14. doi: 10.11138/gchir/2017.38.1.005.</citation>
    <PMID>28460197</PMID>
  </results_reference>
  <results_reference>
    <citation>Simillis C, Thoukididou SN, Slesser AA, Rasheed S, Tan E, Tekkis PP. Systematic review and network meta-analysis comparing clinical outcomes and effectiveness of surgical treatments for haemorrhoids. Br J Surg. 2015 Dec;102(13):1603-18. doi: 10.1002/bjs.9913. Epub 2015 Sep 30.</citation>
    <PMID>26420725</PMID>
  </results_reference>
  <results_reference>
    <citation>Gallo G, Mistrangelo M, Passera R, Testa V, Pozzo M, Perinotti R, Lanati I, Lazzari I, Tonello P, Ugliono E, De Luca E, Realis Luc A, Clerico G, Trompetto M. Efficacy of Mesoglycan in Pain Control after Excisional Hemorrhoidectomy: A Pilot Comparative Prospective Multicenter Study. Gastroenterol Res Pract. 2018 Mar 19;2018:6423895. doi: 10.1155/2018/6423895. eCollection 2018.</citation>
    <PMID>29743886</PMID>
  </results_reference>
  <results_reference>
    <citation>Bessa SS. Diathermy excisional hemorrhoidectomy: a prospective randomized study comparing pedicle ligation and pedicle coagulation. Dis Colon Rectum. 2011 Nov;54(11):1405-11. doi: 10.1097/DCR.0b013e318222b5a9.</citation>
    <PMID>21979186</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</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>Thrombosis</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </patient_data>
  <!-- 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/NCT04481698
org study id: 176/2017
nct id: NCT04481698
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Haemorrhoidal disease (HD) is the most common proctological disease, with a prevalence that
      can reach up to 39% of the population. Although I and II degree HD can be treated
      successfully with medical therapy or office-based procedures , excisional haemorrhoidectomy
      remains the gold standard technique in patients with III and IV degree HD, obtaining a much
      lower rate of recurrence than non-excisional methods, such as Doppler-guided haemorrhoidal
      artery ligation or stapled haemorrhoidopexy. However, both open and closed
      haemorrhoidectomies are associated with a significant rate of post-operative pain , which may
      be due to the incorporation of sensitive anal mucosa and fibres of the internal sphincters
      during the ligation of the vascular pedicle, post-operative scars, hygiene/social habits,
      hard stool, or oedema of the necessary mucocutaneous bridge.

      Regarding the oedema/thrombosis of the mucocutaneous bridges, we strongly believe that it is
      the main cause of post-operative pain, and we have shown that the use of mesoglycan, a
      polysaccharide complex with antithrombotic and profibrinolytic properties, can reduce the
      rate of post-operative thrombosis and consequently post-operative pain 7-10 days after the
      procedures, improving patient quality of life and speeding up the recovery of daily
      activities.

      Furthermore, its usefulness is also evident in the treatment of the acute phase of external
      haemorrhoidal thrombosis.

      The aim of the study was to evaluate the efficacy of mesoglycan in the post-operative period
      of patients who underwent open excisional diathermy haemorrhoidectomy, confirming the
      previously obtained results
This was a retrospective multicentre study and is reported according to the Strengthening the
      Reporting of Observational Studies in Epidemiology (STROBE) statement for cohort studies

      Between September and December 2017, 206 patients with III and IV degree HD, according to
      Goligher classification, from sixteen colorectal referral centres belonging to SICCR (Società
      Italiana di Chirurgia Colorettale), who satisfied inclusion criteria underwent open excision
      haemorrhoidectomy.

      The results obtained were compared with a homogeneous sample of 192 patients who underwent
      OEH in the same centres between April and July 2017 and who had received standard
      post-operative therapy without mesoglycan.

      All patients received the standard post-operative therapy (a recommended oral dose of
      ketorolac tromethamine of 10 mg every 4-6 hours, not exceeding 40 mg per day and not
      exceeding 5 post-operative days according to the indications for short-term management of
      moderate/severe acute post-operative pain and stool softeners) plus mesoglycan (Prisma® 30 mg
      2 vials i.m./day for the first 5 post-operative days and then Prisma® 50 mg 1 oral tablet
      twice/day for an additional 30 days, Mediolanum Farmaceutici, Milan, Italy).

      In each referral centre, the procedures were carried out by an experienced surgeon who had
      performed more than 200 haemorrhoidectomies.

      A clinical external examination was performed the first post-operative day, and an anorectal
      digital evaluation with proctoscopy was performed at T2, T3 and T4.

      During each follow-up visit, post-operative pain was evaluated at rest, after defecation and
      after anorectal digital examination using a visual analogue scale (minimum score = 0; maximum
      score = 10).

      Quality of life was evaluated pre- and post-operatively 90 days after the procedure using the
      SF-12 questionnaire.

      Polypharmacy was defined as 5 or more medications daily. Thrombosis was defined as one or
      more swollen painful piles at the site of the mucocutaneous bridge and was assessed at T2, T3
      and T4.

      Surgical wound healing (granulation) was evaluated at T2, T3 and T4 using the following 3
      items: infected, granulating, healed.

      Autonomy was evaluated at T2, T3 and T4 using the following 4 items: complete inactivity,
      total autonomy at home, ability to drive, return to normal activities (autonomy at home,
      driving, working).

      Bowel movements were evaluated, according to the proper guidelines, at T2, T3 and T4, and
      patients were classified in three categories: regular, constipation or diarrhoea.
observational model: Case-Control
time perspective: Retrospective
measure: Changes in Post-operative Pain
time frame: Day 7, Day 20, Day 40
description: VAS
measure: Changes in post-operative Thrombosis
time frame: Day 7, Day 20, Day 40
description: Dichotomous parameter (Yes or Not)
measure: Changes in post-operative Bleeding
time frame: Day 7, Day 20, Day 40
description: Dichotomous parameter (Yes or Not)
measure: Quality of Life (QoL)
time frame: pre- and post-operatively 90 days after the procedure
description: We used the 12-Item Short Form Survey (SF-12) to assess QoL
measure: Changes in Surgical Wound Healing
time frame: Day 7, Day 20, Day 40
description: we evaluated wound healing with the following scale: infected, granulating, healed
measure: Changes Autonomy
time frame: Day 7, Day 20, Day 40
description: we evaluated autonomy with the following parameters: complete inactivity (patient unable to performing any activity), total autonomy at home, ability to drive, return to normal activities (patient able to performing any activity)
arm group label: Mesoglycan
description: All patients received the standard post-operative therapy (a recommended oral dose of ketorolac tromethamine of 10 mg every 4-6 hours, not exceeding 40 mg per day and not exceeding 5 post-operative days according to the indications for short-term management of moderate/severe acute post-operative pain and stool softeners) plus mesoglycan (Prisma® 30 mg 2 vials i.m./day for the first 5 post-operative days and then Prisma® 50 mg 1 oral tablet twice/day for an additional 30 days, Mediolanum Farmaceutici, Milan, Italy)
arm group label: Control
description: standard post-operative therapy (a recommended oral dose of ketorolac tromethamine of 10 mg every 4-6 hours, not exceeding 40 mg per day and not exceeding 5 post-operative days according to the indications for short-term management of moderate/severe acute post-operative pain and stool softeners)
intervention type: Other
intervention name: Mesoglycan
description: Prisma® 30 mg 2 vials i.m./day for the first 5 post-operative days and then Prisma® 50 mg 1 oral tablet twice/day for an additional 30 days
arm group label: Control
arm group label: Mesoglycan
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Italy
citation: Gallo G, Martellucci J, Sturiale A, Clerico G, Milito G, Marino F, Cocorullo G, Giordano P, Mistrangelo M, Trompetto M. Consensus statement of the Italian society of colorectal surgery (SICCR): management and treatment of hemorrhoidal disease. Tech Coloproctol. 2020 Feb;24(2):145-164. doi: 10.1007/s10151-020-02149-1. Epub 2020 Jan 28.
PMID: 31993837
citation: Cocorullo G, Tutino R, Falco N, Licari L, Orlando G, Fontana T, Raspanti C, Salamone G, Scerrino G, Gallo G, Trompetto M, Gulotta G. The non-surgical management for hemorrhoidal disease. A systematic review. G Chir. 2017 Jan-Feb;38(1):5-14. doi: 10.11138/gchir/2017.38.1.005.
PMID: 28460197
citation: Simillis C, Thoukididou SN, Slesser AA, Rasheed S, Tan E, Tekkis PP. Systematic review and network meta-analysis comparing clinical outcomes and effectiveness of surgical treatments for haemorrhoids. Br J Surg. 2015 Dec;102(13):1603-18. doi: 10.1002/bjs.9913. Epub 2015 Sep 30.
PMID: 26420725
citation: Gallo G, Mistrangelo M, Passera R, Testa V, Pozzo M, Perinotti R, Lanati I, Lazzari I, Tonello P, Ugliono E, De Luca E, Realis Luc A, Clerico G, Trompetto M. Efficacy of Mesoglycan in Pain Control after Excisional Hemorrhoidectomy: A Pilot Comparative Prospective Multicenter Study. Gastroenterol Res Pract. 2018 Mar 19;2018:6423895. doi: 10.1155/2018/6423895. eCollection 2018.
PMID: 29743886
citation: Bessa SS. Diathermy excisional hemorrhoidectomy: a prospective randomized study comparing pedicle ligation and pedicle coagulation. Dis Colon Rectum. 2011 Nov;54(11):1405-11. doi: 10.1097/DCR.0b013e318222b5a9.
PMID: 21979186
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Pain, Postoperative
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)