<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/NCT03306238</url>
  </required_header>
  <id_info>
    <org_study_id>AMNCH-GU-2017-3</org_study_id>
    <nct_id>NCT03306238</nct_id>
  </id_info>
  <brief_title>LAParoscopic Entry Technique in REnal Surgery</brief_title>
  <acronym>LAPRES</acronym>
  <official_title>Laparoscopic Entry Technique in Renal Surgery: a Randomised Controlled Trial Comparing Open (Hasson) Versus Closed (Veress) Techniques.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Adelaide and Meath Hospital, incorporating The National Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Adelaide and Meath Hospital, incorporating The National Children's 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 randomised controlled trial to evaluate safety and efficacy of two different port&#xD;
      site entry techniques in laparoscopic renal surgery: open method (Hasson) and closed method&#xD;
      (Veress). It will involve 300 adult patients undergoing elective laparoscopic renal surgery&#xD;
      in Tallaght hospital under two Consultant urologists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical specialties commonly using laparoscopic techniques like gynecology and general&#xD;
      surgery have extensively compared the various available techniques of port insertion (1).&#xD;
      There is very little known regarding the safest entry technique for the initial port in&#xD;
      laparoscopic renal surgery. Results from other surgical specialties cannot simply be&#xD;
      extrapolated to this type of laparoscopic surgery due to difference in entry site and patient&#xD;
      position with renal surgery. Hence, this randomised controlled trial will be performed in a&#xD;
      urological unit with two laparoscopic renal surgeons to compare two commonly used techniques&#xD;
      of initial trocar insertion: the closed method and the open method.&#xD;
&#xD;
      Background Since its introduction in 1991 by Clayman, laparoscopic renal surgery has become&#xD;
      very popular and is widely used for both benign and malignant renal operations such as&#xD;
      radical, simple and partial nephrectomies, pyeloplasties, nephro-ureterectomies (2). The&#xD;
      overall reported major and minor complication rate of laparoscopic renal surgery is 9.5% and&#xD;
      1.9% respectively (2). Initial entry by trocar insertion is the most hazardous part of the&#xD;
      laparoscopic procedure. Opinion regarding the safest entry technique is divided. The two most&#xD;
      commonly used techniques of port entry include open and closed (3). An open technique, as&#xD;
      first described by Hasson, involves the peritoneum being cut down, followed by the insertion&#xD;
      of a blunt trocar under direct visualisation, gas insufflation, and insertion of the&#xD;
      laparoscope. One of the closed technique involves the insertion of a Veress needle (a needle&#xD;
      equipped with a spring-loaded obturator) into the peritoneal cavity, followed by gas&#xD;
      insufflation (act of blowing) and insertion of a trocar (a sharp, pointed instrument with a&#xD;
      cannula used to enter the body cavity). Finally the laparoscope is passed through the trocar&#xD;
      once the obturator is removed. Previous meta-analyses in laparoscopic surgery from&#xD;
      gynaecological and general surgical operations have not been able to support one technique&#xD;
      over the other due to insufficient evidence.to our knowledge (3), there are no randomised&#xD;
      controlled trials comparing these two techniques in laparoscopic renal surgery. During&#xD;
      laparoscopic renal surgery, the patient is placed in a lateral flank position with the table&#xD;
      flexed. The initial port of entry can be either at the umbilicus or lateral to it. This&#xD;
      position is unique to urological surgery and hence can have different implications to the&#xD;
      initial trocar insertion technique.&#xD;
&#xD;
      The objective is to compare the open method (Hasson) and closed method (Veress) of&#xD;
      laparoscopic port site entry in renal surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2019</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>This is a randomised single blinded prospective trial comparing two similar groups directly to check for differnces in time to approach and complication rate</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The patient and the investigator will not be informed of the type of approach they had. These will be marked as A and B with only the care povide/surgeon being aware of the actual approach. The investigator of complications and assessor of the case outcomes will collect data without the knowledge of the group the patient belongs to. The surgeon or car eprovider cannot be masked in this case due to technical limitations but they will not contribute towards analysing the results.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Complications</measure>
    <time_frame>48 hours</time_frame>
    <description>Minor and major complications assessed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to insertion</measure>
    <time_frame>30 minutes</time_frame>
    <description>Record time taken to perform both approaches</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>Open/Hasson</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will undergo initial laparoscopic port insertion by the open or Hasson approach and then undergo the remaining laparoscopic surgery as usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Closed/ Veress</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will undergo initial laparoscopic port insertion by the closed or Veress approach and then undergo the remaining laparoscopic surgery as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open approach to port insertion</intervention_name>
    <description>This involves the peritoneum being cut down, followed by the insertion of a blunt trocar under direct visualisation, gas insufflation, and insertion of the laparoscope</description>
    <arm_group_label>Open/Hasson</arm_group_label>
    <other_name>Hasson</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Closed approach to port insertion</intervention_name>
    <description>This involves the insertion of a Veress needle (a needle equipped with a spring-loaded obturator) into the peritoneal cavity, followed by gas insufflation (act of blowing) and insertion of a trocar (a sharp, pointed instrument with a cannula used to enter the body cavity).</description>
    <arm_group_label>Closed/ Veress</arm_group_label>
    <other_name>Veress</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Able to undergo a general anaesthetic&#xD;
&#xD;
               -  At least 18 years old&#xD;
&#xD;
               -  Willing and able to give AN INFORMED CONSENT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal obese patients BMI &gt;40mg/m2 previous laparotomy&#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_official>
    <last_name>Arun Z Thomas</last_name>
    <role>Principal Investigator</role>
    <affiliation>AMNCH, Tallaght hospital, Dublin 24</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arun Z Thomas, MCh, FRCS</last_name>
    <phone>0353879804873</phone>
    <email>arun.z.thomas@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Adelaide and Meath hospital incorporating the NAtional Children's hospital</name>
      <address>
        <city>Dublin</city>
        <zip>24</zip>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arun Z Thomas, MCh, FRCS</last_name>
      <phone>00353879804873</phone>
      <email>arun.z.thomas@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <reference>
    <citation>Angioli R, Terranova C, De Cicco Nardone C, Cafa EV, Damiani P, Portuesi R, Muzii L, Plotti F, Zullo MA, Panici PB. A comparison of three different entry techniques in gynecological laparoscopic surgery: a randomized prospective trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):339-42. doi: 10.1016/j.ejogrb.2013.09.012. Epub 2013 Sep 23.</citation>
    <PMID>24103531</PMID>
  </reference>
  <reference>
    <citation>Pareek G, Hedican SP, Gee JR, Bruskewitz RC, Nakada SY. Meta-analysis of the complications of laparoscopic renal surgery: comparison of procedures and techniques. J Urol. 2006 Apr;175(4):1208-13. doi: 10.1016/S0022-5347(05)00639-7.</citation>
    <PMID>16515961</PMID>
  </reference>
  <reference>
    <citation>Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006583. doi: 10.1002/14651858.CD006583.pub3.</citation>
    <PMID>22336819</PMID>
  </reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 23, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>December 19, 2017</last_update_submitted>
  <last_update_submitted_qc>December 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Adelaide and Meath Hospital, incorporating The National Children's Hospital</investigator_affiliation>
    <investigator_full_name>Arun Thomas</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>laparoscopy/ key-hole</keyword>
  <keyword>renal surgery</keyword>
  <keyword>open/hasson</keyword>
  <keyword>closed/veress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03306238
org study id: AMNCH-GU-2017-3
nct id: NCT03306238
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomised controlled trial to evaluate safety and efficacy of two different port
      site entry techniques in laparoscopic renal surgery: open method (Hasson) and closed method
      (Veress). It will involve 300 adult patients undergoing elective laparoscopic renal surgery
      in Tallaght hospital under two Consultant urologists.
Surgical specialties commonly using laparoscopic techniques like gynecology and general
      surgery have extensively compared the various available techniques of port insertion (1).
      There is very little known regarding the safest entry technique for the initial port in
      laparoscopic renal surgery. Results from other surgical specialties cannot simply be
      extrapolated to this type of laparoscopic surgery due to difference in entry site and patient
      position with renal surgery. Hence, this randomised controlled trial will be performed in a
      urological unit with two laparoscopic renal surgeons to compare two commonly used techniques
      of initial trocar insertion: the closed method and the open method.

      Background Since its introduction in 1991 by Clayman, laparoscopic renal surgery has become
      very popular and is widely used for both benign and malignant renal operations such as
      radical, simple and partial nephrectomies, pyeloplasties, nephro-ureterectomies (2). The
      overall reported major and minor complication rate of laparoscopic renal surgery is 9.5% and
      1.9% respectively (2). Initial entry by trocar insertion is the most hazardous part of the
      laparoscopic procedure. Opinion regarding the safest entry technique is divided. The two most
      commonly used techniques of port entry include open and closed (3). An open technique, as
      first described by Hasson, involves the peritoneum being cut down, followed by the insertion
      of a blunt trocar under direct visualisation, gas insufflation, and insertion of the
      laparoscope. One of the closed technique involves the insertion of a Veress needle (a needle
      equipped with a spring-loaded obturator) into the peritoneal cavity, followed by gas
      insufflation (act of blowing) and insertion of a trocar (a sharp, pointed instrument with a
      cannula used to enter the body cavity). Finally the laparoscope is passed through the trocar
      once the obturator is removed. Previous meta-analyses in laparoscopic surgery from
      gynaecological and general surgical operations have not been able to support one technique
      over the other due to insufficient evidence.to our knowledge (3), there are no randomised
      controlled trials comparing these two techniques in laparoscopic renal surgery. During
      laparoscopic renal surgery, the patient is placed in a lateral flank position with the table
      flexed. The initial port of entry can be either at the umbilicus or lateral to it. This
      position is unique to urological surgery and hence can have different implications to the
      initial trocar insertion technique.

      The objective is to compare the open method (Hasson) and closed method (Veress) of
      laparoscopic port site entry in renal surgery
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomised single blinded prospective trial comparing two similar groups directly to check for differnces in time to approach and complication rate
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The patient and the investigator will not be informed of the type of approach they had. These will be marked as A and B with only the care povide/surgeon being aware of the actual approach. The investigator of complications and assessor of the case outcomes will collect data without the knowledge of the group the patient belongs to. The surgeon or car eprovider cannot be masked in this case due to technical limitations but they will not contribute towards analysing the results.
measure: Complications
time frame: 48 hours
description: Minor and major complications assessed
measure: Time to insertion
time frame: 30 minutes
description: Record time taken to perform both approaches
arm group label: Open/Hasson
arm group type: Active Comparator
description: This group will undergo initial laparoscopic port insertion by the open or Hasson approach and then undergo the remaining laparoscopic surgery as usual
arm group label: Closed/ Veress
arm group type: Active Comparator
description: This group will undergo initial laparoscopic port insertion by the closed or Veress approach and then undergo the remaining laparoscopic surgery as usual
intervention type: Procedure
intervention name: Open approach to port insertion
description: This involves the peritoneum being cut down, followed by the insertion of a blunt trocar under direct visualisation, gas insufflation, and insertion of the laparoscope
arm group label: Open/Hasson
other name: Hasson
intervention type: Procedure
intervention name: Closed approach to port insertion
description: This involves the insertion of a Veress needle (a needle equipped with a spring-loaded obturator) into the peritoneal cavity, followed by gas insufflation (act of blowing) and insertion of a trocar (a sharp, pointed instrument with a cannula used to enter the body cavity).
arm group label: Closed/ Veress
other name: Veress
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arun Z Thomas
role: Principal Investigator
affiliation: AMNCH, Tallaght hospital, Dublin 24
last name: Arun Z Thomas, MCh, FRCS
phone: 0353879804873
email: arun.z.thomas@gmail.com
facility: 
status: Recruiting
contact: 
country: Ireland
citation: Angioli R, Terranova C, De Cicco Nardone C, Cafa EV, Damiani P, Portuesi R, Muzii L, Plotti F, Zullo MA, Panici PB. A comparison of three different entry techniques in gynecological laparoscopic surgery: a randomized prospective trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):339-42. doi: 10.1016/j.ejogrb.2013.09.012. Epub 2013 Sep 23.
PMID: 24103531
citation: Pareek G, Hedican SP, Gee JR, Bruskewitz RC, Nakada SY. Meta-analysis of the complications of laparoscopic renal surgery: comparison of procedures and techniques. J Urol. 2006 Apr;175(4):1208-13. doi: 10.1016/S0022-5347(05)00639-7.
PMID: 16515961
citation: Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006583. doi: 10.1002/14651858.CD006583.pub3.
PMID: 22336819
responsible party type: Principal Investigator
investigator affiliation: The Adelaide and Meath Hospital, incorporating The National Children's Hospital
investigator full name: Arun Thomas
investigator title: Principal investigator
mesh term: Kidney Diseases
sharing ipd: Undecided