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Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic

Primary Purpose

Biliary Colic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transvaginal cholecystectomy
laparoscopic cholecystectomy
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Colic focused on measuring cholecystectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female.
  • Age between 18 and 65 years old.
  • Biliary dyskinesia with documented Gallbladder EF < 30% or diagnosis of biliary colic with documented gallstones or polyps by imaging.
  • Body Mass Index (BMI) < 45 kg/m2.

Exclusion Criteria:

  • Any female patient, who is pregnant, suspected pregnant, or lactating.
  • Any patient with acute or acalculous cholecystitis.
  • Any patient with an American Society of Anesthesiologists Score > 3.
  • Any patient who is undergoing Peritoneal Dialysis (PD).
  • Patients who are taking immunosuppressive medications or are immunocompromised.
  • Patients on blood thinners or aspirin or abnormal blood coagulation tests.
  • Patients who have a history of prior open abdominal surgery or prior transvaginal surgery.
  • Patients with a history of ectopic pregnancy, pelvic inflammatory disease (PID) or severe endometriosis.
  • Non English speaking patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention group

    laparoscopic cholecystectomy

    Arm Description

    transvaginal cholecystectomy

    Laparoscopic cholecystectomy (4 port)

    Outcomes

    Primary Outcome Measures

    feasibility of transvaginal cholecystectomy

    Secondary Outcome Measures

    pain
    quality of life

    Full Information

    First Posted
    August 20, 2009
    Last Updated
    January 12, 2018
    Sponsor
    Yale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00963950
    Brief Title
    Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic
    Official Title
    Transvaginal Cholecystectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A safe and effective transvaginal approach accessing the abdominal cavity through the vagina rather than the abdominal wall is today considered a routine approach for many gynecologic surgeries. First described by Dr. Ott in Germany in 1901, it is used routinely for transvaginal surgery, for example, transvaginal hysterectomies. This transvaginal technique has been shown to compare favorably to a laparoscopic abdominal approach because of less postoperative pain, the total elimination of abdominal wall hernias and wound infections, earlier recovery and better cosmesis. Although routinely used in gynecological surgery, the advantages of the vaginal approach have not been utilized for general surgery applications such as cholecystectomies. Open or laparoscopic cholecystectomy accessing the abdominal cavity through abdominal wall incisions is currently still considered the standard of care in general surgery for patients with symptomatic gallbladder disease. The investigators intend to access the abdominal cavity through the posterior vaginal fornix instead of the transabdominal approach that is now performed routinely. So far, this method of accessing the abdominal cavity through the transvaginal approach for the purpose of performing intraabdominal general surgery. The investigators' transvaginal approach has the strong potential to further decrease invasiveness and take minimally invasive surgery to the next level in order to benefit the patient even more by minimizing postoperative pain, eliminating the risk of abdominal hernias and wound infections, improving cosmetic appearance and enabling the patient to return to routine activity and work earlier. First preliminary studies show these advantages but further research needs to be done to confirm these early positive results.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Biliary Colic
    Keywords
    cholecystectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    transvaginal cholecystectomy
    Arm Title
    laparoscopic cholecystectomy
    Arm Type
    Active Comparator
    Arm Description
    Laparoscopic cholecystectomy (4 port)
    Intervention Type
    Procedure
    Intervention Name(s)
    transvaginal cholecystectomy
    Intervention Description
    Transvaginal approach to gallbladder removal.
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic cholecystectomy
    Intervention Description
    laparoscopic cholecystectomy
    Primary Outcome Measure Information:
    Title
    feasibility of transvaginal cholecystectomy
    Time Frame
    2 year
    Secondary Outcome Measure Information:
    Title
    pain
    Time Frame
    2 years
    Title
    quality of life
    Time Frame
    2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female. Age between 18 and 65 years old. Biliary dyskinesia with documented Gallbladder EF < 30% or diagnosis of biliary colic with documented gallstones or polyps by imaging. Body Mass Index (BMI) < 45 kg/m2. Exclusion Criteria: Any female patient, who is pregnant, suspected pregnant, or lactating. Any patient with acute or acalculous cholecystitis. Any patient with an American Society of Anesthesiologists Score > 3. Any patient who is undergoing Peritoneal Dialysis (PD). Patients who are taking immunosuppressive medications or are immunocompromised. Patients on blood thinners or aspirin or abnormal blood coagulation tests. Patients who have a history of prior open abdominal surgery or prior transvaginal surgery. Patients with a history of ectopic pregnancy, pelvic inflammatory disease (PID) or severe endometriosis. Non English speaking patients.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kurt Roberts, MD
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22549370
    Citation
    Solomon D, Shariff AH, Silasi DA, Duffy AJ, Bell RL, Roberts KE. Transvaginal cholecystectomy versus single-incision laparoscopic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective cohort study. Surg Endosc. 2012 Oct;26(10):2823-7. doi: 10.1007/s00464-012-2253-0. Epub 2012 May 2.
    Results Reference
    derived

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    Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic

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