search
Back to results

Laparoscopic Assisted Transvaginal Cholecystecomy

Primary Purpose

Cholelithiasis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic Assisted Transvaginal Cholecystectomy
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cholelithiasis focused on measuring cholecystectomy, gall stone surgery, scarless surgery, cholelithiasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled to undergo elective laparoscopic cholecystectomy
  • Women 18-75 years of age
  • English or Spanish speaking

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification of ≥ 3
  • Morbid obesity (BMI ≥35)
  • Pregnant women
  • Acute cholecystitis
  • Any ongoing intra-abdominal infection
  • Prior upper abdominal or pelvic surgery and/or adhesions
  • Virgins
  • Women with an active sexually transmitted disease or any vaginal infection
  • History of dyspareunia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Transvaginal cholecystectomy under laparoscopic guidance

    Arm Description

    The removal of the gallbladder through several small incisions using a camera to see is called laparoscopic cholecystectomy. This study is being done to evaluate whether cholecystectomy can be performed through a natural orifice (the vagina) with minimal laparoscopic assistance (only one abdominal trocar versus four in the routine laparoscopic cholecystectomy).

    Outcomes

    Primary Outcome Measures

    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Quality of Life scale
    The primary outcome of this study will be to evaluate the feasibility of performing a transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. A postoperative Quality of Life questionnaire will be given to the patient to access pain. We will also address whether cosmesis was a factor for their decision. Operative time will be tracked as well as standard operative outcomes including any complications. Patients will be kept for 23 hours observation postoperatively and will follow up in the clinic.
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Visual Analog Scale
    The primary outcome of this study will be to evaluate the feasibility of performing a transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. A Visual Analog Scale for pain will be given to the patient to access pain. We will also address whether cosmesis was a factor for their decision. Operative time will be tracked as well as standard operative outcomes including any complications. Patients will be kept for 23 hours observation postoperatively and will follow up in the clinic.The Visual Analog Scale is a scale from 0-10, with 10 being a better outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 3, 2012
    Last Updated
    October 1, 2019
    Sponsor
    University of Texas Southwestern Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04113590
    Brief Title
    Laparoscopic Assisted Transvaginal Cholecystecomy
    Official Title
    Laparoscopic Assisted Transvaginal Cholecystecomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no patients were enrolled
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    December 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Laparoscopic cholecystectomy is currently the standard procedure for removing the gallbladder. This procedure usually requires the insertion of four trocars into the abdomen for passage of laparoscopic instruments; each trocar requires a small incision, which results in postoperative pain and scarring. There has recently been a tremendous surge in interest within the surgical community to further reduce the pain, invasiveness, and cosmesis of laparoscopic surgery. To achieve this goal, surgeons are either reducing the number of trocars placed through the abdominal wall or eliminating them completely The goal of this project is to evaluate the feasibility of performing transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. This has the potential to decrease postoperative pain, improve cosmesis, and lead to a shorter recovery following cholecystectomy.
    Detailed Description
    20 female patients will be enrolled. Patients who are scheduled to undergo elective laparoscopic cholecystectomy will be invited to participate in this study. The laparoscopic instrumentation will be sterilized using standard methods. Conventional and new laparoscopic and endoscopic equipment will be used for this project; all equipment is commercially available and is FDA-approved for laparoscopic procedures. Access will be obtained into the peritoneal cavity at the umbilicus in a standard fashion, either by use of a Veress needle technique or by insertion of a trocar using the open technique. Through a single umbilical incision, a 5mm trocar will be placed into the peritoneal cavity. A 5mm laparoscope will then be inserted into the peritoneal cavity. This will be used to monitor safe peritoneal entry of a dilating12mm transvaginal trocar. Subsequent operative visualization will be by use of a flexible endoscope which will be placed through the transvaginal port. The gallbladder will be retracted using sutures as well as endoscopic and / or laparoscopic graspers. In order to obtain the critical view of safety [5] the cystic duct and artery will be dissected, ligated and divided by use of conventional laparoscopic and new articulating instruments. The dissected gallbladder will be retrieved transvaginally. If for any reason suitable retraction or dissection cannot be performed using the transvaginal strategy, the case will be promptly converted to a standard laparoscopic approach by the insertion of additional transabdominal trocars.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholelithiasis
    Keywords
    cholecystectomy, gall stone surgery, scarless surgery, cholelithiasis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Transvaginal cholecystectomy under laparoscopic guidance
    Arm Type
    Experimental
    Arm Description
    The removal of the gallbladder through several small incisions using a camera to see is called laparoscopic cholecystectomy. This study is being done to evaluate whether cholecystectomy can be performed through a natural orifice (the vagina) with minimal laparoscopic assistance (only one abdominal trocar versus four in the routine laparoscopic cholecystectomy).
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic Assisted Transvaginal Cholecystectomy
    Other Intervention Name(s)
    Transvaginal (TV) NOTES, scarless cholecystectomy, cholecystectomy
    Intervention Description
    Perform transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization
    Primary Outcome Measure Information:
    Title
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Quality of Life scale
    Description
    The primary outcome of this study will be to evaluate the feasibility of performing a transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. A postoperative Quality of Life questionnaire will be given to the patient to access pain. We will also address whether cosmesis was a factor for their decision. Operative time will be tracked as well as standard operative outcomes including any complications. Patients will be kept for 23 hours observation postoperatively and will follow up in the clinic.
    Time Frame
    23 hours post op
    Title
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Visual Analog Scale
    Description
    The primary outcome of this study will be to evaluate the feasibility of performing a transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. A Visual Analog Scale for pain will be given to the patient to access pain. We will also address whether cosmesis was a factor for their decision. Operative time will be tracked as well as standard operative outcomes including any complications. Patients will be kept for 23 hours observation postoperatively and will follow up in the clinic.The Visual Analog Scale is a scale from 0-10, with 10 being a better outcome.
    Time Frame
    23 hours post op

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Scheduled to undergo elective laparoscopic cholecystectomy Women 18-75 years of age English or Spanish speaking Exclusion Criteria: American Society of Anesthesiologists (ASA) classification of ≥ 3 Morbid obesity (BMI ≥35) Pregnant women Acute cholecystitis Any ongoing intra-abdominal infection Prior upper abdominal or pelvic surgery and/or adhesions Virgins Women with an active sexually transmitted disease or any vaginal infection History of dyspareunia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Scott, MD
    Organizational Affiliation
    UT Southwestern
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17704871
    Citation
    Scott DJ, Tang SJ, Fernandez R, Bergs R, Goova MT, Zeltser I, Kehdy FJ, Cadeddu JA. Completely transvaginal NOTES cholecystectomy using magnetically anchored instruments. Surg Endosc. 2007 Dec;21(12):2308-16. doi: 10.1007/s00464-007-9498-z. Epub 2007 Aug 18.
    Results Reference
    background
    PubMed Identifier
    18027043
    Citation
    Zorron R, Maggioni LC, Pombo L, Oliveira AL, Carvalho GL, Filgueiras M. NOTES transvaginal cholecystectomy: preliminary clinical application. Surg Endosc. 2008 Feb;22(2):542-7. doi: 10.1007/s00464-007-9646-5. Epub 2007 Nov 20.
    Results Reference
    background
    PubMed Identifier
    21449152
    Citation
    Elazary R, Khalaileh A, Shussman N, Schlager A, Horgan S, Talamini MA, Rivkind AI, Mintz Y. [Surgery without incisions--the third generation of surgery]. Harefuah. 2011 Jan;150(1):25-8, 69. Hebrew.
    Results Reference
    background
    PubMed Identifier
    20035352
    Citation
    Schlager A, Khalaileh A, Shussman N, Elazary R, Keidar A, Pikarsky AJ, Ben-Shushan A, Shibolet O, Horgan S, Talamini M, Zamir G, Rivkind AI, Mintz Y. Providing more through less: current methods of retraction in SIMIS and NOTES cholecystectomy. Surg Endosc. 2010 Jul;24(7):1542-6. doi: 10.1007/s00464-009-0807-6. Epub 2009 Dec 25.
    Results Reference
    background
    PubMed Identifier
    18722948
    Citation
    Christian J, Barrier BF, Schust D, Miedema BW, Thaler K. Culdoscopy: a foundation for natural orifice surgery--past, present, and future. J Am Coll Surg. 2008 Sep;207(3):417-22. doi: 10.1016/j.jamcollsurg.2008.01.032. Epub 2008 May 5. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21553172
    Citation
    Auyang ED, Santos BF, Enter DH, Hungness ES, Soper NJ. Natural orifice translumenal endoscopic surgery (NOTES((R))): a technical review. Surg Endosc. 2011 Oct;25(10):3135-48. doi: 10.1007/s00464-011-1718-x. Epub 2011 May 7.
    Results Reference
    background

    Learn more about this trial

    Laparoscopic Assisted Transvaginal Cholecystecomy

    We'll reach out to this number within 24 hrs