<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/NCT03304509</url>
  </required_header>
  <id_info>
    <org_study_id>GermansTIPH</org_study_id>
    <nct_id>NCT03304509</nct_id>
  </id_info>
  <brief_title>Comparative Study Between Conventional and Telematic Patients Follow-up</brief_title>
  <acronym>TLM-CGD</acronym>
  <official_title>Comparative Study Between Conventional and Telematic Follow-up of Patient Treated in a General Ang GI Surgery Department (TLM-CGD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Germans Trias i Pujol Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Germans Trias i Pujol Hospital</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>
      This is a parallel group clinical trial comparing two types of follow-up in patients operated&#xD;
      and treated in a General and GI surgery department. Face-to-face vs telematic follow-up by&#xD;
      using a platform that offers videoconferencing will be compared.&#xD;
&#xD;
      Patients will be included and assigned randomly to each group using an informatics program&#xD;
      until 100 patients are reached in each arm of the study (&quot;n&quot; total = 200 patients) The main&#xD;
      and secondary outcomes will be evaluated 30 days after the date of the follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a parallel group clinical trial comparing two types of follow-up in patients operated&#xD;
      and treated in a General and GI surgery department. Face-to-face vs telematic follow-up by&#xD;
      using a platform that offers videoconferencing will be compared.&#xD;
&#xD;
      The hypothesis is that a follow-up based on a telematic visit will no add extra comorbidities&#xD;
      while could reduce costs and increase patients satisfaction.&#xD;
&#xD;
      Patients will be included and assigned randomly to each group using an informatics program&#xD;
      until 100 patients are reached in each arm of the study (&quot;n&quot; total = 200 patients)&#xD;
      Information regarding the type of follow-up and the instructions to perform the telematic&#xD;
      visit will be provided to patients before discharge. The follow-up date will be set according&#xD;
      to the established protocol for each type of pathology.&#xD;
&#xD;
      In case of clinical complications patients will be referred to the emergency department or&#xD;
      will be visited in face-to-face basis.&#xD;
&#xD;
      The main and secondary outcomes will be evaluated 30 days after the date of the follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 19, 2017</start_date>
  <completion_date type="Actual">August 23, 2018</completion_date>
  <primary_completion_date type="Actual">May 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will be included and assigned randomly, using an informatic program, to one of the study arms before hospital discharge.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Follow-up accomplishment</measure>
    <time_frame>From date of discharge until the date of follow-up, 30 days after discharge</time_frame>
    <description>Percentage of patients that can finish the follow-up in the assigned group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emergency department consultation</measure>
    <time_frame>From discharge until 30 days after the follow-up date</time_frame>
    <description>Comparison between number of emergency department consultations in each group if related to the surgical procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>30 days after the follow-up date</time_frame>
    <description>Assessment of the patient satisfaction related to the follow-up using the NHS Outpatients Questionnaire. The results will be the comparision of percentage of each answer in each group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Telemedicine</condition>
  <condition>General Surgery</condition>
  <condition>Outpatients</condition>
  <arm_group>
    <arm_group_label>Face-to-face follow-up</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Face-to-face follow-up after hospital discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telematic follow-up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telematic follow-up after hospital discharge</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telematic follow-up</intervention_name>
    <description>Telematic follow-up by using a platform with videoconference</description>
    <arm_group_label>Telematic follow-up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients treated or operated in the General and GI Surgery department in &quot;Hospital&#xD;
             Germans Trias i Pujol&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Proctological Surgery&#xD;
&#xD;
          -  Personal conditions that not allow a correct comprehension or developement of the&#xD;
             study&#xD;
&#xD;
          -  Patients with postoperative complications greater than Clavien-Dindo grade II&#xD;
&#xD;
          -  Not being in possession of the necessary informatic devices in case of telematic&#xD;
             follow-up&#xD;
&#xD;
          -  Not having a basic informatic knowledge in case of telematic follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manel Cremades, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>General and GI Surgical Department Staff</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Johnston MJ, King D, Arora S, Behar N, Athanasiou T, Sevdalis N, Darzi A. Smartphones let surgeons know WhatsApp: an analysis of communication in emergency surgical teams. Am J Surg. 2015 Jan;209(1):45-51. doi: 10.1016/j.amjsurg.2014.08.030. Epub 2014 Oct 22.</citation>
    <PMID>25454952</PMID>
  </reference>
  <reference>
    <citation>Khanna V, Sambandam SN, Gul A, Mounasamy V. &quot;WhatsApp&quot;ening in orthopedic care: a concise report from a 300-bedded tertiary care teaching center. Eur J Orthop Surg Traumatol. 2015 Jul;25(5):821-6. doi: 10.1007/s00590-015-1600-y. Epub 2015 Jan 30.</citation>
    <PMID>25633127</PMID>
  </reference>
  <reference>
    <citation>Kvedar J, Coye MJ, Everett W. Connected health: a review of technologies and strategies to improve patient care with telemedicine and telehealth. Health Aff (Millwood). 2014 Feb;33(2):194-9. doi: 10.1377/hlthaff.2013.0992.</citation>
    <PMID>24493760</PMID>
  </reference>
  <reference>
    <citation>Armstrong KA, Coyte PC, Bhatia RS, Semple JL. The effect of mobile app home monitoring on number of in-person visits following ambulatory surgery: protocol for a randomized controlled trial. JMIR Res Protoc. 2015 Jun 3;4(2):e65. doi: 10.2196/resprot.4352.</citation>
    <PMID>26040252</PMID>
  </reference>
  <reference>
    <citation>Dobke MK, Bhavsar D, Gosman A, De Neve J, De Neve B. Pilot trial of telemedicine as a decision aid for patients with chronic wounds. Telemed J E Health. 2008 Apr;14(3):245-9. doi: 10.1089/tmj.2007.0038.</citation>
    <PMID>18570547</PMID>
  </reference>
  <reference>
    <citation>Weinstein RS, Lopez AM, Joseph BA, Erps KA, Holcomb M, Barker GP, Krupinski EA. Telemedicine, telehealth, and mobile health applications that work: opportunities and barriers. Am J Med. 2014 Mar;127(3):183-7. doi: 10.1016/j.amjmed.2013.09.032. Epub 2013 Oct 29.</citation>
    <PMID>24384059</PMID>
  </reference>
  <reference>
    <citation>Shah MN, Wasserman EB, Gillespie SM, Wood NE, Wang H, Noyes K, Nelson D, Dozier A, McConnochie KM. High-Intensity Telemedicine Decreases Emergency Department Use for Ambulatory Care Sensitive Conditions by Older Adult Senior Living Community Residents. J Am Med Dir Assoc. 2015 Dec;16(12):1077-81. doi: 10.1016/j.jamda.2015.07.009. Epub 2015 Aug 17.</citation>
    <PMID>26293419</PMID>
  </reference>
  <reference>
    <citation>Eisenberg D, Hwa K, Wren SM. Telephone follow-up by a midlevel provider after laparoscopic inguinal hernia repair instead of face-to-face clinic visit. JSLS. 2015 Jan-Mar;19(1):e2014.00205. doi: 10.4293/JSLS.2014.00205.</citation>
    <PMID>25848178</PMID>
  </reference>
  <reference>
    <citation>Charles BL. Telemedicine can lower costs and improve access. Healthc Financ Manage. 2000 Apr;54(4):66-9.</citation>
    <PMID>10915354</PMID>
  </reference>
  <reference>
    <citation>Pericas JM, Aibar J, Soler N, Lopez-Soto A, Sanclemente-Anso C, Bosch X. Should alternatives to conventional hospitalisation be promoted in an era of financial constraint? Eur J Clin Invest. 2013 Jun;43(6):602-15. doi: 10.1111/eci.12087. Epub 2013 Apr 17.</citation>
    <PMID>23590593</PMID>
  </reference>
  <reference>
    <citation>Bator EX, Gleason JM, Lorenzo AJ, Kanaroglou N, Farhat WA, Bagli DJ, Koyle MA. The burden of attending a pediatric surgical clinic and family preferences toward telemedicine. J Pediatr Surg. 2015 Oct;50(10):1776-82. doi: 10.1016/j.jpedsurg.2015.06.005. Epub 2015 Jun 20.</citation>
    <PMID>26195452</PMID>
  </reference>
  <reference>
    <citation>Rasmussen BS, Froekjaer J, Bjerregaard MR, Lauritsen J, Hangaard J, Henriksen CW, Halekoh U, Yderstraede KB. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care. 2015 Sep;38(9):1723-9. doi: 10.2337/dc15-0332. Epub 2015 Jun 26.</citation>
    <PMID>26116717</PMID>
  </reference>
  <reference>
    <citation>Sathiyakumar V, Apfeld JC, Obremskey WT, Thakore RV, Sethi MK. Prospective randomized controlled trial using telemedicine for follow-ups in an orthopedic trauma population: a pilot study. J Orthop Trauma. 2015 Mar;29(3):e139-45. doi: 10.1097/BOT.0000000000000189.</citation>
    <PMID>24983434</PMID>
  </reference>
  <reference>
    <citation>Sharareh B, Schwarzkopf R. Effectiveness of telemedical applications in postoperative follow-up after total joint arthroplasty. J Arthroplasty. 2014 May;29(5):918-922.e1. doi: 10.1016/j.arth.2013.09.019. Epub 2013 Dec 15.</citation>
    <PMID>24342278</PMID>
  </reference>
  <reference>
    <citation>Piqueras M, Marco E, Coll M, Escalada F, Ballester A, Cinca C, Belmonte R, Muniesa JM. Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. J Rehabil Med. 2013 Apr;45(4):392-6. doi: 10.2340/16501977-1119.</citation>
    <PMID>23474735</PMID>
  </reference>
  <reference>
    <citation>Robaldo A, Rousas N, Pane B, Spinella G, Palombo D. Telemedicine in vascular surgery: clinical experience in a single centre. J Telemed Telecare. 2010;16(7):374-7. doi: 10.1258/jtt.2010.091011. Epub 2010 Aug 2.</citation>
    <PMID>20679407</PMID>
  </reference>
  <reference>
    <citation>Fallaize RC, Tinline-Purvis C, Dixon AR, Pullyblank AM. Telephone follow-up following office anorectal surgery. Ann R Coll Surg Engl. 2008 Sep;90(6):464-6. doi: 10.1308/003588408X300975. Epub 2008 Jul 2.</citation>
    <PMID>18598594</PMID>
  </reference>
  <reference>
    <citation>Haukipuro K, Ohinmaa A, Winblad I, Linden T, Vuolio S. The feasibility of telemedicine for orthopaedic outpatient clinics--a randomized controlled trial. J Telemed Telecare. 2000;6(4):193-8. doi: 10.1258/1357633001935347.</citation>
    <PMID>11027118</PMID>
  </reference>
  <reference>
    <citation>Wallace P, Haines A, Harrison R, Barber J, Thompson S, Jacklin P, Roberts J, Lewis L, Wainwright P; Virtual Outreach Project Group. Joint teleconsultations (virtual outreach) versus standard outpatient appointments for patients referred by their general practitioner for a specialist opinion: a randomised trial. Lancet. 2002 Jun 8;359(9322):1961-8. doi: 10.1016/s0140-6736(02)08828-1.</citation>
    <PMID>12076550</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 30, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>August 23, 2018</last_update_submitted>
  <last_update_submitted_qc>August 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Germans Trias i Pujol Hospital</investigator_affiliation>
    <investigator_full_name>Manel Cremades</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All the study will be carried out in our institution and no individual data will be shared with other researchers or investigation centers unless if needed to support our study results</ipd_description>
  </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/NCT03304509
org study id: GermansTIPH
nct id: NCT03304509
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a parallel group clinical trial comparing two types of follow-up in patients operated
      and treated in a General and GI surgery department. Face-to-face vs telematic follow-up by
      using a platform that offers videoconferencing will be compared.

      Patients will be included and assigned randomly to each group using an informatics program
      until 100 patients are reached in each arm of the study ("n" total = 200 patients) The main
      and secondary outcomes will be evaluated 30 days after the date of the follow-up.
This is a parallel group clinical trial comparing two types of follow-up in patients operated
      and treated in a General and GI surgery department. Face-to-face vs telematic follow-up by
      using a platform that offers videoconferencing will be compared.

      The hypothesis is that a follow-up based on a telematic visit will no add extra comorbidities
      while could reduce costs and increase patients satisfaction.

      Patients will be included and assigned randomly to each group using an informatics program
      until 100 patients are reached in each arm of the study ("n" total = 200 patients)
      Information regarding the type of follow-up and the instructions to perform the telematic
      visit will be provided to patients before discharge. The follow-up date will be set according
      to the established protocol for each type of pathology.

      In case of clinical complications patients will be referred to the emergency department or
      will be visited in face-to-face basis.

      The main and secondary outcomes will be evaluated 30 days after the date of the follow-up.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be included and assigned randomly, using an informatic program, to one of the study arms before hospital discharge.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Follow-up accomplishment
time frame: From date of discharge until the date of follow-up, 30 days after discharge
description: Percentage of patients that can finish the follow-up in the assigned group
measure: Emergency department consultation
time frame: From discharge until 30 days after the follow-up date
description: Comparison between number of emergency department consultations in each group if related to the surgical procedure
measure: Patient satisfaction
time frame: 30 days after the follow-up date
description: Assessment of the patient satisfaction related to the follow-up using the NHS Outpatients Questionnaire. The results will be the comparision of percentage of each answer in each group.
arm group label: Face-to-face follow-up
arm group type: No Intervention
description: Face-to-face follow-up after hospital discharge
arm group label: Telematic follow-up
arm group type: Experimental
description: Telematic follow-up after hospital discharge
intervention type: Other
intervention name: Telematic follow-up
description: Telematic follow-up by using a platform with videoconference
arm group label: Telematic follow-up
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Manel Cremades, MD
role: Principal Investigator
affiliation: General and GI Surgical Department Staff
facility: 
country: Spain
citation: Johnston MJ, King D, Arora S, Behar N, Athanasiou T, Sevdalis N, Darzi A. Smartphones let surgeons know WhatsApp: an analysis of communication in emergency surgical teams. Am J Surg. 2015 Jan;209(1):45-51. doi: 10.1016/j.amjsurg.2014.08.030. Epub 2014 Oct 22.
PMID: 25454952
citation: Khanna V, Sambandam SN, Gul A, Mounasamy V. "WhatsApp"ening in orthopedic care: a concise report from a 300-bedded tertiary care teaching center. Eur J Orthop Surg Traumatol. 2015 Jul;25(5):821-6. doi: 10.1007/s00590-015-1600-y. Epub 2015 Jan 30.
PMID: 25633127
citation: Kvedar J, Coye MJ, Everett W. Connected health: a review of technologies and strategies to improve patient care with telemedicine and telehealth. Health Aff (Millwood). 2014 Feb;33(2):194-9. doi: 10.1377/hlthaff.2013.0992.
PMID: 24493760
citation: Armstrong KA, Coyte PC, Bhatia RS, Semple JL. The effect of mobile app home monitoring on number of in-person visits following ambulatory surgery: protocol for a randomized controlled trial. JMIR Res Protoc. 2015 Jun 3;4(2):e65. doi: 10.2196/resprot.4352.
PMID: 26040252
citation: Dobke MK, Bhavsar D, Gosman A, De Neve J, De Neve B. Pilot trial of telemedicine as a decision aid for patients with chronic wounds. Telemed J E Health. 2008 Apr;14(3):245-9. doi: 10.1089/tmj.2007.0038.
PMID: 18570547
citation: Weinstein RS, Lopez AM, Joseph BA, Erps KA, Holcomb M, Barker GP, Krupinski EA. Telemedicine, telehealth, and mobile health applications that work: opportunities and barriers. Am J Med. 2014 Mar;127(3):183-7. doi: 10.1016/j.amjmed.2013.09.032. Epub 2013 Oct 29.
PMID: 24384059
citation: Shah MN, Wasserman EB, Gillespie SM, Wood NE, Wang H, Noyes K, Nelson D, Dozier A, McConnochie KM. High-Intensity Telemedicine Decreases Emergency Department Use for Ambulatory Care Sensitive Conditions by Older Adult Senior Living Community Residents. J Am Med Dir Assoc. 2015 Dec;16(12):1077-81. doi: 10.1016/j.jamda.2015.07.009. Epub 2015 Aug 17.
PMID: 26293419
citation: Eisenberg D, Hwa K, Wren SM. Telephone follow-up by a midlevel provider after laparoscopic inguinal hernia repair instead of face-to-face clinic visit. JSLS. 2015 Jan-Mar;19(1):e2014.00205. doi: 10.4293/JSLS.2014.00205.
PMID: 25848178
citation: Charles BL. Telemedicine can lower costs and improve access. Healthc Financ Manage. 2000 Apr;54(4):66-9.
PMID: 10915354
citation: Pericas JM, Aibar J, Soler N, Lopez-Soto A, Sanclemente-Anso C, Bosch X. Should alternatives to conventional hospitalisation be promoted in an era of financial constraint? Eur J Clin Invest. 2013 Jun;43(6):602-15. doi: 10.1111/eci.12087. Epub 2013 Apr 17.
PMID: 23590593
citation: Bator EX, Gleason JM, Lorenzo AJ, Kanaroglou N, Farhat WA, Bagli DJ, Koyle MA. The burden of attending a pediatric surgical clinic and family preferences toward telemedicine. J Pediatr Surg. 2015 Oct;50(10):1776-82. doi: 10.1016/j.jpedsurg.2015.06.005. Epub 2015 Jun 20.
PMID: 26195452
citation: Rasmussen BS, Froekjaer J, Bjerregaard MR, Lauritsen J, Hangaard J, Henriksen CW, Halekoh U, Yderstraede KB. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care. 2015 Sep;38(9):1723-9. doi: 10.2337/dc15-0332. Epub 2015 Jun 26.
PMID: 26116717
citation: Sathiyakumar V, Apfeld JC, Obremskey WT, Thakore RV, Sethi MK. Prospective randomized controlled trial using telemedicine for follow-ups in an orthopedic trauma population: a pilot study. J Orthop Trauma. 2015 Mar;29(3):e139-45. doi: 10.1097/BOT.0000000000000189.
PMID: 24983434
citation: Sharareh B, Schwarzkopf R. Effectiveness of telemedical applications in postoperative follow-up after total joint arthroplasty. J Arthroplasty. 2014 May;29(5):918-922.e1. doi: 10.1016/j.arth.2013.09.019. Epub 2013 Dec 15.
PMID: 24342278
citation: Piqueras M, Marco E, Coll M, Escalada F, Ballester A, Cinca C, Belmonte R, Muniesa JM. Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. J Rehabil Med. 2013 Apr;45(4):392-6. doi: 10.2340/16501977-1119.
PMID: 23474735
citation: Robaldo A, Rousas N, Pane B, Spinella G, Palombo D. Telemedicine in vascular surgery: clinical experience in a single centre. J Telemed Telecare. 2010;16(7):374-7. doi: 10.1258/jtt.2010.091011. Epub 2010 Aug 2.
PMID: 20679407
citation: Fallaize RC, Tinline-Purvis C, Dixon AR, Pullyblank AM. Telephone follow-up following office anorectal surgery. Ann R Coll Surg Engl. 2008 Sep;90(6):464-6. doi: 10.1308/003588408X300975. Epub 2008 Jul 2.
PMID: 18598594
citation: Haukipuro K, Ohinmaa A, Winblad I, Linden T, Vuolio S. The feasibility of telemedicine for orthopaedic outpatient clinics--a randomized controlled trial. J Telemed Telecare. 2000;6(4):193-8. doi: 10.1258/1357633001935347.
PMID: 11027118
citation: Wallace P, Haines A, Harrison R, Barber J, Thompson S, Jacklin P, Roberts J, Lewis L, Wainwright P; Virtual Outreach Project Group. Joint teleconsultations (virtual outreach) versus standard outpatient appointments for patients referred by their general practitioner for a specialist opinion: a randomised trial. Lancet. 2002 Jun 8;359(9322):1961-8. doi: 10.1016/s0140-6736(02)08828-1.
PMID: 12076550
responsible party type: Principal Investigator
investigator affiliation: Germans Trias i Pujol Hospital
investigator full name: Manel Cremades
investigator title: MD
sharing ipd: No
ipd description: All the study will be carried out in our institution and no individual data will be shared with other researchers or investigation centers unless if needed to support our study results