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
About this trial
This is an interventional treatment trial for Biliary Colic focused on measuring cholecystectomy
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.
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
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
Learn more about this trial
Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic
We'll reach out to this number within 24 hrs