<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/NCT01685775</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1114-7386</org_study_id>
    <secondary_id>DRKS00000341</secondary_id>
    <nct_id>NCT01685775</nct_id>
  </id_info>
  <brief_title>Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy</brief_title>
  <acronym>NATCH</acronym>
  <official_title>Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Witten/Herdecke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Witten/Herdecke</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic surgery has become the golden standard for the removal of the gallbladder.&#xD;
      Recently, developments have been made so that operations can be performed through a natural&#xD;
      orifice instead of the abdominal wall, thus minimizing the trauma of a procedure. This study&#xD;
      compares the transvaginal/transumbilical cholecystectomy with the laparoscopic operation&#xD;
      using 2-3mm instruments in female patients. It also examines the benefits and disadvantages&#xD;
      related to postoperative pain, cosmetic aspects, and potential physiological alterations to&#xD;
      the transvaginal approach that affect sexual intercourse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The amount of trauma inflicted, especially in abdominal operations, depends largely on target&#xD;
      organ access. Great efforts have been made to minimize access trauma. The further development&#xD;
      of laparoscopy led to the miniaturization of surgical instruments and otherwise the use of&#xD;
      natural orifices, like the stomach, rectum or vagina. The cholecystectomy is currently&#xD;
      performed needlescopicly with 2-3 mm trocars and in transumbilically assisted transvaginal&#xD;
      technique. The aim of this randomized study is to compare these two techniques in female&#xD;
      patients that are in need of an elective cholecystectomy. The patients will be randomized on&#xD;
      a 1:1 ratio into two treatment groups. In the needlescopic group the investigators will use&#xD;
      two 2-3 mm working trocars and one 10 mm optic trocar, also to extract the gallbladder. In&#xD;
      the transvaginal/transumbilical group the investigators will perform the Zornig technique&#xD;
      using a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps&#xD;
      through the posterior vaginal vault. The primary endpoint of this trial is to measure the&#xD;
      intensity of pain in motion measured from the day of the operation until postoperative day 2.&#xD;
      Four different measurements of pain will be used. Furthermore the investigators examine&#xD;
      perioperative complications as security parameters. The trial is supported in part by the&#xD;
      German Ministry of Research and Education (CHIR-Net grant, BMBF No. 01-GH-0605).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at the operation day</time_frame>
    <description>Pain Scores on the Visual Analog Scale (0-10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at postoperative day 1</time_frame>
    <description>2 measures (in the morning and in the evening) Pain Scores on the Visual Analog Scale (0-10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at postoperative day 2</time_frame>
    <description>Pain Scores on the Visual Analog Scale (0-10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cosmetic aspects and overall satisfaction with the results of the surgery</measure>
    <time_frame>10 days after operation</time_frame>
    <description>1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative complications</measure>
    <time_frame>evaluated at the operation day</time_frame>
    <description>e.g. bleeding, organ-injury, especially bile-duct-injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of the operation</measure>
    <time_frame>at the operation day</time_frame>
    <description>(in minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical handling for the first and second surgeon</measure>
    <time_frame>evaluated at the operation day</time_frame>
    <description>on a 1 to 5 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at postoperative day 2</time_frame>
    <description>in the evening pain Scores on the Visual Analog Scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative use of analgesics</measure>
    <time_frame>10 days after the surgery</time_frame>
    <description>quantity, dose and class of the used drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to everyday, work related and free time activities</measure>
    <time_frame>3 months after operation</time_frame>
    <description>duration of limitations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>on postoperative day 10</time_frame>
    <description>measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative restrictions of sexual function</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>with questions 14-19 of the &quot;female sexual function index&quot; (FSFI-D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphological consequences of transvaginal access</measure>
    <time_frame>at the day before the operation, and again 10 to 14 days and 6 months after their surgery</time_frame>
    <description>all patients from the transvaginal/transumbilical group will be examined by a gynaecologist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmetic aspects and overall satisfaction with the results of the surgery</measure>
    <time_frame>3 months after operation</time_frame>
    <description>1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmetic aspects and overall satisfaction with the results of the surgery</measure>
    <time_frame>6 months after operation</time_frame>
    <description>1 (complete satisfaction) to 5 (complete dissatisfaction) scale; from patient's and surgeon's point of view</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conversionrate</measure>
    <time_frame>at the operation day</time_frame>
    <description>Conversion from transvaginal to classical laparoscopic or open technique and from needlescopic to open technique</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>at 6 month</time_frame>
    <description>including frequency of reoperation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at postoperative day 3</time_frame>
    <description>in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at postoperative day 4</time_frame>
    <description>in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at postoperative day 5</time_frame>
    <description>in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at postoperative day 6</time_frame>
    <description>in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at postoperative day 7</time_frame>
    <description>in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at postoperative day 8</time_frame>
    <description>in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at postoperative day 9</time_frame>
    <description>in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain in motion</measure>
    <time_frame>at postoperative day 10</time_frame>
    <description>in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Calculus of Gallbladder With or Without Cholecystitis</condition>
  <condition>Laparoscopic Cholecystectomy</condition>
  <arm_group>
    <arm_group_label>Transvaginal/transumbilical cholecystectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transvaginal/transumbilical group: we will use a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps through the posterior vaginal vault to perform the cholecystectomy in the Zornig style</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Needlescopic cholecystectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Needlescopic cholecystectomy with 3 trocars: we will use two 2-3 mm working trocars and one 10 mm optic trocar, its access is also used for extraction of the gallbladder</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transvaginal/transumbilical</intervention_name>
    <arm_group_label>Transvaginal/transumbilical cholecystectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Needlescopic with 3 trocars</intervention_name>
    <arm_group_label>Needlescopic cholecystectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gender: Female&#xD;
&#xD;
          -  Minimum Age: 18 Years&#xD;
&#xD;
          -  Maximum Age: 80 Years&#xD;
&#xD;
          -  indication for elective cholecystectomy on account of symptomatic cholecystolithiasis&#xD;
&#xD;
          -  age &gt;=18 years and &lt;=80 years&#xD;
&#xD;
          -  legal competence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute cholecystitis or locally complicated disease (gallbladder empyema,&#xD;
             choledocholithiasis, pancreatitis, etc.)&#xD;
&#xD;
          -  liver cirrhosis (Child Pugh A, B, C)&#xD;
&#xD;
          -  severe comorbidity, class IV or V as defined by the American Society for&#xD;
             Anesthesiologists (ASA)&#xD;
&#xD;
          -  intact hymen&#xD;
&#xD;
          -  acute vaginal infection&#xD;
&#xD;
          -  lacking visibility of the uterine orifice&#xD;
&#xD;
          -  endometriosis&#xD;
&#xD;
          -  malignoma&#xD;
&#xD;
          -  obesity with a Body Mass Index (BMI) &gt; 40 kg/m2&#xD;
&#xD;
          -  chronic abuse of analgesics or alcohol&#xD;
&#xD;
          -  neuromuscular disease that could interfere treatment or measures of pain&#xD;
&#xD;
          -  history of major abdominal surgery with a high risk of intraperitoneal adhesions&#xD;
             (minor operations such as an appendectomy, inguinal hernia repair, minor&#xD;
             gynaecological surgery, etc. will not be considered exclusion criteria)&#xD;
&#xD;
          -  gravidity or breastfeeding&#xD;
&#xD;
          -  allergy against analgesics&#xD;
&#xD;
          -  patients who are dependent on or employed by the trial sponsor or physicians&#xD;
&#xD;
          -  institutionalisation for legal reasons&#xD;
&#xD;
          -  participation in other clinical studies that could interfere with the present trial&#xD;
&#xD;
          -  no written informed consent signed&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dirk R. Bulian</last_name>
    <role>Principal Investigator</role>
    <affiliation>Witten/Herdecke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Abdominal, Vascular and Transplant Surgery; Cologne-Merheim Medical Center</name>
      <address>
        <city>Cologne</city>
        <zip>51109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Bulian DR, Trump L, Knuth J, Siegel R, Sauerwald A, Strohlein MA, Heiss MM. Less pain after transvaginal/transumbilical cholecystectomy than after the classical laparoscopic technique: short-term results of a matched-cohort study. Surg Endosc. 2013 Feb;27(2):580-6. doi: 10.1007/s00464-012-2490-2. Epub 2012 Aug 28.</citation>
    <PMID>22926893</PMID>
  </reference>
  <reference>
    <citation>Bulian DR, Trump L, Knuth J, Cerasani N, Heiss MM. Long-term results of transvaginal/transumbilical versus classical laparoscopic cholecystectomy--an analysis of 88 patients. Langenbecks Arch Surg. 2013 Apr;398(4):571-9. doi: 10.1007/s00423-013-1071-8. Epub 2013 Mar 1.</citation>
    <PMID>23456357</PMID>
  </reference>
  <results_reference>
    <citation>Bulian DR, Knuth J, Cerasani N, Sauerwald A, Lefering R, Heiss MM. Transvaginal/transumbilical hybrid--NOTES--versus 3-trocar needlescopic cholecystectomy: short-term results of a randomized clinical trial. Ann Surg. 2015 Mar;261(3):451-8. doi: 10.1097/SLA.0000000000000218.</citation>
    <PMID>24108196</PMID>
  </results_reference>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>October 12, 2013</last_update_submitted>
  <last_update_submitted_qc>October 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Witten/Herdecke</investigator_affiliation>
    <investigator_full_name>Dirk R. Bulian</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Gallbladder</keyword>
  <keyword>cholecystectomy</keyword>
  <keyword>NOTES</keyword>
  <keyword>natural orifice transluminal endoscopic surgery</keyword>
  <keyword>gallstone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</mesh_term>
    <mesh_term>Gallstones</mesh_term>
    <mesh_term>Calculi</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/NCT01685775
org study id: U1111-1114-7386
secondary id: DRKS00000341
nct id: NCT01685775
lead sponsor: 
has dmc: No
Laparoscopic surgery has become the golden standard for the removal of the gallbladder.
      Recently, developments have been made so that operations can be performed through a natural
      orifice instead of the abdominal wall, thus minimizing the trauma of a procedure. This study
      compares the transvaginal/transumbilical cholecystectomy with the laparoscopic operation
      using 2-3mm instruments in female patients. It also examines the benefits and disadvantages
      related to postoperative pain, cosmetic aspects, and potential physiological alterations to
      the transvaginal approach that affect sexual intercourse.
The amount of trauma inflicted, especially in abdominal operations, depends largely on target
      organ access. Great efforts have been made to minimize access trauma. The further development
      of laparoscopy led to the miniaturization of surgical instruments and otherwise the use of
      natural orifices, like the stomach, rectum or vagina. The cholecystectomy is currently
      performed needlescopicly with 2-3 mm trocars and in transumbilically assisted transvaginal
      technique. The aim of this randomized study is to compare these two techniques in female
      patients that are in need of an elective cholecystectomy. The patients will be randomized on
      a 1:1 ratio into two treatment groups. In the needlescopic group the investigators will use
      two 2-3 mm working trocars and one 10 mm optic trocar, also to extract the gallbladder. In
      the transvaginal/transumbilical group the investigators will perform the Zornig technique
      using a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps
      through the posterior vaginal vault. The primary endpoint of this trial is to measure the
      intensity of pain in motion measured from the day of the operation until postoperative day 2.
      Four different measurements of pain will be used. Furthermore the investigators examine
      perioperative complications as security parameters. The trial is supported in part by the
      German Ministry of Research and Education (CHIR-Net grant, BMBF No. 01-GH-0605).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intensity of pain in motion
time frame: at the operation day
description: Pain Scores on the Visual Analog Scale (0-10)
measure: Intensity of pain in motion
time frame: at postoperative day 1
description: 2 measures (in the morning and in the evening) Pain Scores on the Visual Analog Scale (0-10)
measure: Intensity of pain in motion
time frame: at postoperative day 2
description: Pain Scores on the Visual Analog Scale (0-10)
measure: Cosmetic aspects and overall satisfaction with the results of the surgery
time frame: 10 days after operation
description: 1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view
measure: Intraoperative complications
time frame: evaluated at the operation day
description: e.g. bleeding, organ-injury, especially bile-duct-injury
measure: Duration of the operation
time frame: at the operation day
description: (in minutes)
measure: Surgical handling for the first and second surgeon
time frame: evaluated at the operation day
description: on a 1 to 5 scale
measure: Intensity of pain in motion
time frame: at postoperative day 2
description: in the evening pain Scores on the Visual Analog Scale (0-10)
measure: Cumulative use of analgesics
time frame: 10 days after the surgery
description: quantity, dose and class of the used drugs
measure: Return to everyday, work related and free time activities
time frame: 3 months after operation
description: duration of limitations.
measure: Quality of life
time frame: on postoperative day 10
description: measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al.
measure: Postoperative restrictions of sexual function
time frame: 3 months after surgery
description: with questions 14-19 of the "female sexual function index" (FSFI-D)
measure: Morphological consequences of transvaginal access
time frame: at the day before the operation, and again 10 to 14 days and 6 months after their surgery
description: all patients from the transvaginal/transumbilical group will be examined by a gynaecologist
measure: Cosmetic aspects and overall satisfaction with the results of the surgery
time frame: 3 months after operation
description: 1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view
measure: Cosmetic aspects and overall satisfaction with the results of the surgery
time frame: 6 months after operation
description: 1 (complete satisfaction) to 5 (complete dissatisfaction) scale; from patient's and surgeon's point of view
measure: Conversionrate
time frame: at the operation day
description: Conversion from transvaginal to classical laparoscopic or open technique and from needlescopic to open technique
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: at 6 month
description: including frequency of reoperation
measure: Intensity of pain in motion
time frame: at postoperative day 3
description: in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
measure: Intensity of pain in motion
time frame: at postoperative day 4
description: in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
measure: Intensity of pain in motion
time frame: at postoperative day 5
description: in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
measure: Intensity of pain in motion
time frame: at postoperative day 6
description: in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
measure: Intensity of pain in motion
time frame: at postoperative day 7
description: in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
measure: Intensity of pain in motion
time frame: at postoperative day 8
description: in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
measure: Intensity of pain in motion
time frame: at postoperative day 9
description: in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
measure: Intensity of pain in motion
time frame: at postoperative day 10
description: in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
arm group label: Transvaginal/transumbilical cholecystectomy
arm group type: Experimental
description: Transvaginal/transumbilical group: we will use a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps through the posterior vaginal vault to perform the cholecystectomy in the Zornig style
arm group label: Needlescopic cholecystectomy
arm group type: Active Comparator
description: Needlescopic cholecystectomy with 3 trocars: we will use two 2-3 mm working trocars and one 10 mm optic trocar, its access is also used for extraction of the gallbladder
intervention type: Procedure
intervention name: Transvaginal/transumbilical
arm group label: Transvaginal/transumbilical cholecystectomy
intervention type: Procedure
intervention name: Needlescopic with 3 trocars
arm group label: Needlescopic cholecystectomy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Dirk R. Bulian
role: Principal Investigator
affiliation: Witten/Herdecke University
facility: 
country: Germany
citation: Bulian DR, Trump L, Knuth J, Siegel R, Sauerwald A, Strohlein MA, Heiss MM. Less pain after transvaginal/transumbilical cholecystectomy than after the classical laparoscopic technique: short-term results of a matched-cohort study. Surg Endosc. 2013 Feb;27(2):580-6. doi: 10.1007/s00464-012-2490-2. Epub 2012 Aug 28.
PMID: 22926893
citation: Bulian DR, Trump L, Knuth J, Cerasani N, Heiss MM. Long-term results of transvaginal/transumbilical versus classical laparoscopic cholecystectomy--an analysis of 88 patients. Langenbecks Arch Surg. 2013 Apr;398(4):571-9. doi: 10.1007/s00423-013-1071-8. Epub 2013 Mar 1.
PMID: 23456357
citation: Bulian DR, Knuth J, Cerasani N, Sauerwald A, Lefering R, Heiss MM. Transvaginal/transumbilical hybrid--NOTES--versus 3-trocar needlescopic cholecystectomy: short-term results of a randomized clinical trial. Ann Surg. 2015 Mar;261(3):451-8. doi: 10.1097/SLA.0000000000000218.
PMID: 24108196
responsible party type: Principal Investigator
investigator affiliation: University of Witten/Herdecke
investigator full name: Dirk R. Bulian
investigator title: Principal Investigator
mesh term: Cholecystitis
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
mesh term: Gallstones
mesh term: Calculi