<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/NCT03018964</url>
  </required_header>
  <id_info>
    <org_study_id>SILC_HoOp</org_study_id>
    <nct_id>NCT03018964</nct_id>
  </id_info>
  <brief_title>Solo Single Incision Laparoscopic Cholecystectomy</brief_title>
  <official_title>A Prospective Multicenter Randomized Controlled Study for The Safety of Single Incision Laparoscopic Cholecystectomy With a Camera Holder Versus With a Camera Operator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chungbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gyeongsang National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to determine safety of solo surgery in single incision&#xD;
      laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator&#xD;
      assisted SILC&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multicenter randomized controlled study. The primary outcome based on&#xD;
      non-inferior study design(α=0.05, power (1-β)=0.90); comparing a complications rate between&#xD;
      Solo-SILC group and conventional cholecystectomy group (Ca-SILC).&#xD;
&#xD;
      Total of 272 patients who were undergoing laparoscopic cholecystectomy for gallbladder&#xD;
      disorders will randomly assign to two groups according to a computer-generated table of&#xD;
      random numbers Solo-SILC group using a laparoscopic camera holder (n=136) or Ca-SILC group in&#xD;
      which a camera operator joins (n=136). .&#xD;
&#xD;
      Demographics (i.e., age, gender, body mass index (BMI), American Society of Anesthesiology&#xD;
      (ASA) score, indication for operation, need for conversion to open surgery or additional port&#xD;
      will be recorded. Outcome including pain, hernia, complication rates, post-cholecystectomy&#xD;
      diarrhea, operator's workload will be investigated&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2020</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC)</measure>
    <time_frame>average 2 weeks</time_frame>
    <description>intraoperative and immediate postoperative complications in Solo-SILC comparing with that in laparoscopic cholecystectomy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>complications in both groups</measure>
    <time_frame>average 2 weeks</time_frame>
    <description>intraoperative and postoperative complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conversion rate</measure>
    <time_frame>intraoperative</time_frame>
    <description>intraoperative conversion rate to open or additional port surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incisional hernia</measure>
    <time_frame>average 6 months</time_frame>
    <description>Umbilical incisional hernia incidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound, back, and shoulder pain</measure>
    <time_frame>postoperative 6 hr, 24 hr, 2 weeks after the operation</time_frame>
    <description>Access the patient's pain using the visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative adverse symptoms after SILC</measure>
    <time_frame>average 2weeks after discharge</time_frame>
    <description>Diet change, post-cholecystectomy diarrhea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participant with abnormal laboratory values</measure>
    <time_frame>average 2weeks after discharge</time_frame>
    <description>postoperative laboratory findings on visiting outpatient's clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operator's workload</measure>
    <time_frame>intraoperative</time_frame>
    <description>Access a operator's workload just after solo surgery comparing to Ca-SILC group using NASA Task Load Index (NASA-TLX) score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">272</enrollment>
  <condition>Cholecystectomy, Laparoscopic</condition>
  <arm_group>
    <arm_group_label>Solo-SILC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Solo surgery using a laparoscopic camera holder instead of a camera operator in SILC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ca-SILC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No solo surgery, operation with a camera operator in SILC</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Solo surgery</intervention_name>
    <description>Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy</description>
    <arm_group_label>Solo-SILC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>operation with a camera operator in SILC</intervention_name>
    <description>conventional single incision laparoscopic cholecystectomy with a scopist</description>
    <arm_group_label>Ca-SILC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patient need laparoscopic cholecystectomy (check the possibility of routine&#xD;
             application of Solo-SILC in clinical practice)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mirizzi syndrome&#xD;
&#xD;
          -  unstable vital sign&#xD;
&#xD;
          -  no compliance&#xD;
&#xD;
          -  no consent&#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>Soyeon Ahn, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Research Collaboration Center Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>YoungRok Choi, M.D.</last_name>
    <phone>+821093212477</phone>
    <email>choiyoungrok@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ho-Jeong Jeong, R.N.</last_name>
    <phone>+821095267743</phone>
    <email>r1441@snubh.org</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Navarra G, Pozza E, Occhionorelli S, Carcoforo P, Donini I. One-wound laparoscopic cholecystectomy. Br J Surg. 1997 May;84(5):695. No abstract available.</citation>
    <PMID>9171771</PMID>
  </results_reference>
  <results_reference>
    <citation>Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20.</citation>
    <PMID>20174950</PMID>
  </results_reference>
  <results_reference>
    <citation>Marks J, Tacchino R, Roberts K, Onders R, Denoto G, Paraskeva P, Rivas H, Soper N, Rosemurgy A, Shah S. Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data. Am J Surg. 2011 Mar;201(3):369-72; discussion 372-3. doi: 10.1016/j.amjsurg.2010.09.012.</citation>
    <PMID>21367381</PMID>
  </results_reference>
  <results_reference>
    <citation>Markar SR, Karthikesalingam A, Thrumurthy S, Muirhead L, Kinross J, Paraskeva P. Single-incision laparoscopic surgery (SILS) vs. conventional multiport cholecystectomy: systematic review and meta-analysis. Surg Endosc. 2012 May;26(5):1205-13. doi: 10.1007/s00464-011-2051-0. Epub 2011 Dec 16.</citation>
    <PMID>22173546</PMID>
  </results_reference>
  <results_reference>
    <citation>Phillips MS, Marks JM, Roberts K, Tacchino R, Onders R, DeNoto G, Rivas H, Islam A, Soper N, Gecelter G, Rubach E, Paraskeva P, Shah S. Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy. Surg Endosc. 2012 May;26(5):1296-303. doi: 10.1007/s00464-011-2028-z. Epub 2011 Nov 15.</citation>
    <PMID>22083331</PMID>
  </results_reference>
  <results_reference>
    <citation>Deveci U, Barbaros U, Kapakli MS, Manukyan MN, Simsek S, Kebudi A, Mercan S. The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study. J Korean Surg Soc. 2013 Dec;85(6):275-82. doi: 10.4174/jkss.2013.85.6.275. Epub 2013 Nov 26.</citation>
    <PMID>24368985</PMID>
  </results_reference>
  <results_reference>
    <citation>Gillen S, Pletzer B, Heiligensetzer A, Wolf P, Kleeff J, Feussner H, Furst A. Solo-surgical laparoscopic cholecystectomy with a joystick-guided camera device: a case-control study. Surg Endosc. 2014 Jan;28(1):164-70. doi: 10.1007/s00464-013-3142-x. Epub 2013 Aug 29.</citation>
    <PMID>23990155</PMID>
  </results_reference>
  <results_reference>
    <citation>Sasaki K, Watanabe G, Matsuda M, Hashimoto M. Original single-incision laparoscopic cholecystectomy for acute inflammation of the gallbladder. World J Gastroenterol. 2012 Mar 7;18(9):944-51. doi: 10.3748/wjg.v18.i9.944.</citation>
    <PMID>22408354</PMID>
  </results_reference>
  <results_reference>
    <citation>Chuang SH, Chen PH, Chang CM, Lin CS. Single-incision vs three-incision laparoscopic cholecystectomy for complicated and uncomplicated acute cholecystitis. World J Gastroenterol. 2013 Nov 21;19(43):7743-50. doi: 10.3748/wjg.v19.i43.7743.</citation>
    <PMID>24282363</PMID>
  </results_reference>
  <results_reference>
    <citation>Sinha R, Yadav AS. Transumbilical single incision laparoscopic cholecystectomy with conventional instruments: A continuing study. J Minim Access Surg. 2014 Oct;10(4):175-9. doi: 10.4103/0972-9941.141502.</citation>
    <PMID>25336816</PMID>
  </results_reference>
  <results_reference>
    <citation>Saber AA, El-Ghazaly TH, Dewoolkar AV, Slayton SA. Single-incision laparoscopic sleeve gastrectomy versus conventional multiport laparoscopic sleeve gastrectomy: technical considerations and strategic modifications. Surg Obes Relat Dis. 2010 Nov-Dec;6(6):658-64. doi: 10.1016/j.soard.2010.03.004. Epub 2010 Mar 19.</citation>
    <PMID>20727831</PMID>
  </results_reference>
  <results_reference>
    <citation>Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available.</citation>
    <PMID>8000648</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>YoungRok Choi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Single incision</keyword>
  <keyword>Solo surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound</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/NCT03018964
org study id: SILC_HoOp
nct id: NCT03018964
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine safety of solo surgery in single incision
      laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator
      assisted SILC
This study is a multicenter randomized controlled study. The primary outcome based on
      non-inferior study design(α=0.05, power (1-β)=0.90); comparing a complications rate between
      Solo-SILC group and conventional cholecystectomy group (Ca-SILC).

      Total of 272 patients who were undergoing laparoscopic cholecystectomy for gallbladder
      disorders will randomly assign to two groups according to a computer-generated table of
      random numbers Solo-SILC group using a laparoscopic camera holder (n=136) or Ca-SILC group in
      which a camera operator joins (n=136). .

      Demographics (i.e., age, gender, body mass index (BMI), American Society of Anesthesiology
      (ASA) score, indication for operation, need for conversion to open surgery or additional port
      will be recorded. Outcome including pain, hernia, complication rates, post-cholecystectomy
      diarrhea, operator's workload will be investigated
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC)
time frame: average 2 weeks
description: intraoperative and immediate postoperative complications in Solo-SILC comparing with that in laparoscopic cholecystectomy
measure: complications in both groups
time frame: average 2 weeks
description: intraoperative and postoperative complications
measure: Conversion rate
time frame: intraoperative
description: intraoperative conversion rate to open or additional port surgery
measure: Incisional hernia
time frame: average 6 months
description: Umbilical incisional hernia incidence
measure: Wound, back, and shoulder pain
time frame: postoperative 6 hr, 24 hr, 2 weeks after the operation
description: Access the patient's pain using the visual analog scale
measure: Postoperative adverse symptoms after SILC
time frame: average 2weeks after discharge
description: Diet change, post-cholecystectomy diarrhea
measure: number of participant with abnormal laboratory values
time frame: average 2weeks after discharge
description: postoperative laboratory findings on visiting outpatient's clinic
measure: Operator's workload
time frame: intraoperative
description: Access a operator's workload just after solo surgery comparing to Ca-SILC group using NASA Task Load Index (NASA-TLX) score
arm group label: Solo-SILC
arm group type: Experimental
description: Solo surgery using a laparoscopic camera holder instead of a camera operator in SILC
arm group label: Ca-SILC
arm group type: Active Comparator
description: No solo surgery, operation with a camera operator in SILC
intervention type: Procedure
intervention name: Solo surgery
description: Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy
arm group label: Solo-SILC
intervention type: Procedure
intervention name: operation with a camera operator in SILC
description: conventional single incision laparoscopic cholecystectomy with a scopist
arm group label: Ca-SILC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Soyeon Ahn, Ph.D.
role: Principal Investigator
affiliation: Medical Research Collaboration Center Seoul National University Bundang Hospital
last name: YoungRok Choi, M.D.
phone: +821093212477
email: choiyoungrok@gmail.com
last name: Ho-Jeong Jeong, R.N.
phone: +821095267743
email: r1441@snubh.org
citation: Navarra G, Pozza E, Occhionorelli S, Carcoforo P, Donini I. One-wound laparoscopic cholecystectomy. Br J Surg. 1997 May;84(5):695. No abstract available.
PMID: 9171771
citation: Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20.
PMID: 20174950
citation: Marks J, Tacchino R, Roberts K, Onders R, Denoto G, Paraskeva P, Rivas H, Soper N, Rosemurgy A, Shah S. Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data. Am J Surg. 2011 Mar;201(3):369-72; discussion 372-3. doi: 10.1016/j.amjsurg.2010.09.012.
PMID: 21367381
citation: Markar SR, Karthikesalingam A, Thrumurthy S, Muirhead L, Kinross J, Paraskeva P. Single-incision laparoscopic surgery (SILS) vs. conventional multiport cholecystectomy: systematic review and meta-analysis. Surg Endosc. 2012 May;26(5):1205-13. doi: 10.1007/s00464-011-2051-0. Epub 2011 Dec 16.
PMID: 22173546
citation: Phillips MS, Marks JM, Roberts K, Tacchino R, Onders R, DeNoto G, Rivas H, Islam A, Soper N, Gecelter G, Rubach E, Paraskeva P, Shah S. Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy. Surg Endosc. 2012 May;26(5):1296-303. doi: 10.1007/s00464-011-2028-z. Epub 2011 Nov 15.
PMID: 22083331
citation: Deveci U, Barbaros U, Kapakli MS, Manukyan MN, Simsek S, Kebudi A, Mercan S. The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study. J Korean Surg Soc. 2013 Dec;85(6):275-82. doi: 10.4174/jkss.2013.85.6.275. Epub 2013 Nov 26.
PMID: 24368985
citation: Gillen S, Pletzer B, Heiligensetzer A, Wolf P, Kleeff J, Feussner H, Furst A. Solo-surgical laparoscopic cholecystectomy with a joystick-guided camera device: a case-control study. Surg Endosc. 2014 Jan;28(1):164-70. doi: 10.1007/s00464-013-3142-x. Epub 2013 Aug 29.
PMID: 23990155
citation: Sasaki K, Watanabe G, Matsuda M, Hashimoto M. Original single-incision laparoscopic cholecystectomy for acute inflammation of the gallbladder. World J Gastroenterol. 2012 Mar 7;18(9):944-51. doi: 10.3748/wjg.v18.i9.944.
PMID: 22408354
citation: Chuang SH, Chen PH, Chang CM, Lin CS. Single-incision vs three-incision laparoscopic cholecystectomy for complicated and uncomplicated acute cholecystitis. World J Gastroenterol. 2013 Nov 21;19(43):7743-50. doi: 10.3748/wjg.v19.i43.7743.
PMID: 24282363
citation: Sinha R, Yadav AS. Transumbilical single incision laparoscopic cholecystectomy with conventional instruments: A continuing study. J Minim Access Surg. 2014 Oct;10(4):175-9. doi: 10.4103/0972-9941.141502.
PMID: 25336816
citation: Saber AA, El-Ghazaly TH, Dewoolkar AV, Slayton SA. Single-incision laparoscopic sleeve gastrectomy versus conventional multiport laparoscopic sleeve gastrectomy: technical considerations and strategic modifications. Surg Obes Relat Dis. 2010 Nov-Dec;6(6):658-64. doi: 10.1016/j.soard.2010.03.004. Epub 2010 Mar 19.
PMID: 20727831
citation: Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available.
PMID: 8000648
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: YoungRok Choi
investigator title: Professor
mesh term: Surgical Wound
sharing ipd: Undecided