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Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic

Transvaginal Cholecystectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00963950
Enrollment
30
Registered
2009-08-24
Start date
2009-08-31
Completion date
2014-03-31
Last updated
2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Colic

Keywords

cholecystectomy

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.

Interventions

Transvaginal approach to gallbladder removal.

PROCEDURElaparoscopic cholecystectomy

laparoscopic cholecystectomy

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
feasibility of transvaginal cholecystectomy2 year

Secondary

MeasureTime frame
pain2 years
quality of life2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026