<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/NCT04447170</url>
  </required_header>
  <id_info>
    <org_study_id>I-Go-GIPS_2020_1</org_study_id>
    <nct_id>NCT04447170</nct_id>
  </id_info>
  <brief_title>Laparoscopic Versus Open Repair of Peptic Ulcer Perforation</brief_title>
  <acronym>LOREPUP</acronym>
  <official_title>Comparison Between Laparoscopic and Open Repair of Perforated Gastroduodenal Peptic Ulcer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gianluca Costa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</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>
      Although laparoscopic repair (LR) of perforated peptic ulcers (PPUs) has long been accepted,&#xD;
      clinical evidence comparing LR versus open repair (OR) remains lacking. The aim of this study&#xD;
      is to evaluate the feasibility, safety and outcome of laparoscopic gastric repair and compare&#xD;
      it with the outcome open repair by relying on a propensity score matching statistical&#xD;
      technique&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the evolution of medical management of Gastroduodenal Peptic Ulcer (GPU),&#xD;
      complications like bleeding and perforation are still not uncommon in clinical practice.&#xD;
      According to the literature in average, 2-14% of peptic ulcers result in perforation, most&#xD;
      215 commonly occurring in females over the age of 60 and chronic NSAID, alcohol or tobacco&#xD;
      users.&#xD;
&#xD;
      Management of perforated peptic ulcer entails resuscitation, pharmacotherapy and surgery.&#xD;
&#xD;
      Traditionally, suture with or without omental patch has been considered the 'gold standard'&#xD;
      and still is. It is associated with shorter length of stay, lower transfusion needs and has&#xD;
      lower morbidity as compared to gastrectomy. In 1992, it has been proposed that laparoscopy&#xD;
      should be routinely considered in the management of perforated duodenal ulcer. Nowadays due&#xD;
      to the advances in laparoscopic technique, many publications suggest that laparoscopic repair&#xD;
      of perforated peptic ulcers could be a superior choice to open repair. These is linked with&#xD;
      the advantages of laparoscopic surgery over open surgery such as reduced postoperative pain,&#xD;
      lower wound infection rate, decreased length of hospital stay, and earlier functional&#xD;
      recovery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>30-day Mortality Rate</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>30-day Morbidity Rate</measure>
    <time_frame>18 months</time_frame>
    <description>Morbidity defined by mean of the most used classification scoring system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Conversion rate</measure>
    <time_frame>18 months</time_frame>
    <description>Defined when a procedure was attempted via the minimally invasive approach but required an open incision to be completed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculation of Boey index</measure>
    <time_frame>18 months</time_frame>
    <description>Calculation and evaluation of its predictive value for morbidity and mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculation of Mannheim Peritonitis Index</measure>
    <time_frame>18 months</time_frame>
    <description>Calculation and evaluation of its predictive value for morbidity and mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculation of Shock index</measure>
    <time_frame>18 months</time_frame>
    <description>Calculation and evaluation of its predictive value for morbidity and mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculation of Age-related shock index</measure>
    <time_frame>18 months</time_frame>
    <description>Calculation and evaluation of its predictive value for morbidity and mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>18 months</time_frame>
    <description>The duration time of surgical step from in&#xD;
The duration of the surgical procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculation of Charlson Age-Comorbidity Index (CACI)</measure>
    <time_frame>18 months</time_frame>
    <description>Calculation and evaluation of its predictive value for morbidity and mortality</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Surgery</condition>
  <condition>Emergencies</condition>
  <condition>Peptic Ulcer Perforation</condition>
  <arm_group>
    <arm_group_label>Laparoscopic repair</arm_group_label>
    <description>Patients undergoing laparoscopic treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open repair</arm_group_label>
    <description>Patients undergoing open treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Simple repair or Graham technique</intervention_name>
    <description>Simple suture with or without omental protective patch</description>
    <arm_group_label>Laparoscopic repair</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Multicenter italian national case-control study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients surgically treated for benign peptic ulcer perforation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Pregnant and breastfeeding women&#xD;
&#xD;
          -  Malignant ulcer perforation&#xD;
&#xD;
          -  Gastric resection&#xD;
&#xD;
          -  Diagnostic laparoscopy/laparotomy with no further surgical procedures performed&#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_contact>
    <last_name>Gianluca Costa, MD, PhD</last_name>
    <phone>00393921119067</phone>
    <email>gianlucacostaphd@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pietro Fransvea, MD</last_name>
    <phone>00393289275731</phone>
    <email>Pietro.fransvea@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Policlinico San Pietro</name>
      <address>
        <city>Ponte San Pietro</city>
        <state>Bergamo</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mauro Montuori, MD</last_name>
    </contact>
    <investigator>
      <last_name>Enrico Pinotti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara</name>
      <address>
        <city>Ferrara</city>
        <state>Emilia-Romagna</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Savino Occhionorelli, MD</last_name>
    </contact>
    <investigator>
      <last_name>Savino Occhionorelli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Camillo Forlanini di Roma</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierluigi Marini, MD</last_name>
    </contact>
    <investigator>
      <last_name>Pietro Fransvea, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Cristo Re</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Crucitti, MD</last_name>
    </contact>
    <investigator>
      <last_name>Casimiro Nigro, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giorgio Rossi, MD</last_name>
    </contact>
    <investigator>
      <last_name>Tiberio Canini, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona</name>
      <address>
        <city>Ancona</city>
        <state>Marche</state>
        <zip>60121</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paolo Ruscelli, MD</last_name>
    </contact>
    <investigator>
      <last_name>Pietro Coletta, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Civile di Adria</name>
      <address>
        <city>Adria</city>
        <state>Rovigo</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ferdinando Agresta, MD</last_name>
    </contact>
    <investigator>
      <last_name>Elena Finotti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cagliari University Hospital Monserrato</name>
      <address>
        <city>Cagliari</city>
        <state>Sardegna</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adolfo Pisanu, Prof.</last_name>
    </contact>
    <investigator>
      <last_name>Mauro Podda, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale della Misericordia Grosseto</name>
      <address>
        <city>Grosseto</city>
        <state>Toscana</state>
        <zip>58100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paolo Pietro Bianchi, MD</last_name>
    </contact>
    <investigator>
      <last_name>Martina De Luca, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Pisana Policlinico Universitario Cisanello</name>
      <address>
        <city>Pisa</city>
        <state>Toscana</state>
        <zip>56121</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Massimo Chiarugi, MD</last_name>
    </contact>
    <investigator>
      <last_name>Dario Tartaglia, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale San Giovanni Battista</name>
      <address>
        <city>Foligno</city>
        <state>Umbria</state>
        <zip>06034</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Graziano Ceccarelli, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Santa Maria</name>
      <address>
        <city>Terni</city>
        <state>Umbria</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola Avenia, MD</last_name>
    </contact>
    <investigator>
      <last_name>Fabio Rondelli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A. Gemelli IRCCS</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pietro Fransvea</last_name>
    </contact>
    <investigator>
      <last_name>Pietro Fransvea</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Cirocchi R, Soreide K, Di Saverio S, Rossi E, Arezzo A, Zago M, Abraha I, Vettoretto N, Chiarugi M. Meta-analysis of perioperative outcomes of acute laparoscopic versus open repair of perforated gastroduodenal ulcers. J Trauma Acute Care Surg. 2018 Aug;85(2):417-425. doi: 10.1097/TA.0000000000001925.</citation>
    <PMID>29659470</PMID>
  </reference>
  <results_reference>
    <citation>Ge B, Wu M, Chen Q, Chen Q, Lin R, Liu L, Huang Q. A prospective randomized controlled trial of laparoscopic repair versus open repair for perforated peptic ulcers. Surgery. 2016 Feb;159(2):451-8. doi: 10.1016/j.surg.2015.07.021. Epub 2015 Aug 19.</citation>
    <PMID>26297055</PMID>
  </results_reference>
  <results_reference>
    <citation>Siow SL, Mahendran HA, Wong CM, Hardin M, Luk TL. Laparoscopic versus open repair of perforated peptic ulcer: Improving outcomes utilizing a standardized technique. Asian J Surg. 2018 Mar;41(2):136-142. doi: 10.1016/j.asjsur.2016.11.004. Epub 2016 Dec 7.</citation>
    <PMID>27955872</PMID>
  </results_reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>December 28, 2021</last_update_submitted>
  <last_update_submitted_qc>December 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Gianluca Costa</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Peptic ulcer perforation</keyword>
  <keyword>Laparoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peptic Ulcer</mesh_term>
    <mesh_term>Peptic Ulcer Perforation</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Ulcer</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/NCT04447170
org study id: I-Go-GIPS_2020_1
nct id: NCT04447170
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although laparoscopic repair (LR) of perforated peptic ulcers (PPUs) has long been accepted,
      clinical evidence comparing LR versus open repair (OR) remains lacking. The aim of this study
      is to evaluate the feasibility, safety and outcome of laparoscopic gastric repair and compare
      it with the outcome open repair by relying on a propensity score matching statistical
      technique
Despite the evolution of medical management of Gastroduodenal Peptic Ulcer (GPU),
      complications like bleeding and perforation are still not uncommon in clinical practice.
      According to the literature in average, 2-14% of peptic ulcers result in perforation, most
      215 commonly occurring in females over the age of 60 and chronic NSAID, alcohol or tobacco
      users.

      Management of perforated peptic ulcer entails resuscitation, pharmacotherapy and surgery.

      Traditionally, suture with or without omental patch has been considered the 'gold standard'
      and still is. It is associated with shorter length of stay, lower transfusion needs and has
      lower morbidity as compared to gastrectomy. In 1992, it has been proposed that laparoscopy
      should be routinely considered in the management of perforated duodenal ulcer. Nowadays due
      to the advances in laparoscopic technique, many publications suggest that laparoscopic repair
      of perforated peptic ulcers could be a superior choice to open repair. These is linked with
      the advantages of laparoscopic surgery over open surgery such as reduced postoperative pain,
      lower wound infection rate, decreased length of hospital stay, and earlier functional
      recovery
observational model: Case-Control
time perspective: Other
measure: 30-day Mortality Rate
time frame: 18 months
measure: 30-day Morbidity Rate
time frame: 18 months
description: Morbidity defined by mean of the most used classification scoring system
measure: Conversion rate
time frame: 18 months
description: Defined when a procedure was attempted via the minimally invasive approach but required an open incision to be completed
measure: Calculation of Boey index
time frame: 18 months
description: Calculation and evaluation of its predictive value for morbidity and mortality
measure: Calculation of Mannheim Peritonitis Index
time frame: 18 months
description: Calculation and evaluation of its predictive value for morbidity and mortality
measure: Calculation of Shock index
time frame: 18 months
description: Calculation and evaluation of its predictive value for morbidity and mortality
measure: Calculation of Age-related shock index
time frame: 18 months
description: Calculation and evaluation of its predictive value for morbidity and mortality
measure: Operative time
time frame: 18 months
description: The duration time of surgical step from in
The duration of the surgical procedure
measure: Calculation of Charlson Age-Comorbidity Index (CACI)
time frame: 18 months
description: Calculation and evaluation of its predictive value for morbidity and mortality
arm group label: Laparoscopic repair
description: Patients undergoing laparoscopic treatment
arm group label: Open repair
description: Patients undergoing open treatment
intervention type: Procedure
intervention name: Simple repair or Graham technique
description: Simple suture with or without omental protective patch
arm group label: Laparoscopic repair
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gianluca Costa, MD, PhD
phone: 00393921119067
email: gianlucacostaphd@gmail.com
last name: Pietro Fransvea, MD
phone: 00393289275731
email: Pietro.fransvea@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
citation: Cirocchi R, Soreide K, Di Saverio S, Rossi E, Arezzo A, Zago M, Abraha I, Vettoretto N, Chiarugi M. Meta-analysis of perioperative outcomes of acute laparoscopic versus open repair of perforated gastroduodenal ulcers. J Trauma Acute Care Surg. 2018 Aug;85(2):417-425. doi: 10.1097/TA.0000000000001925.
PMID: 29659470
citation: Ge B, Wu M, Chen Q, Chen Q, Lin R, Liu L, Huang Q. A prospective randomized controlled trial of laparoscopic repair versus open repair for perforated peptic ulcers. Surgery. 2016 Feb;159(2):451-8. doi: 10.1016/j.surg.2015.07.021. Epub 2015 Aug 19.
PMID: 26297055
citation: Siow SL, Mahendran HA, Wong CM, Hardin M, Luk TL. Laparoscopic versus open repair of perforated peptic ulcer: Improving outcomes utilizing a standardized technique. Asian J Surg. 2018 Mar;41(2):136-142. doi: 10.1016/j.asjsur.2016.11.004. Epub 2016 Dec 7.
PMID: 27955872
responsible party type: Sponsor-Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Gianluca Costa
investigator title: Professor
mesh term: Peptic Ulcer
mesh term: Peptic Ulcer Perforation
mesh term: Emergencies
mesh term: Ulcer