Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic

Biliary Colic Clinical Trial

Official title:

Transvaginal Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963950
• Other study ID #: 0902004771
• Status: Completed
• Phase: N/A
• First received: August 20, 2009
• Last updated: January 12, 2018
• Start date: August 2009
• Est. completion date: March 2014

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Colic
• Colic

Intervention

Procedure:
• transvaginal cholecystectomy
Transvaginal approach to gallbladder removal.
• laparoscopic cholecystectomy
laparoscopic cholecystectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of transvaginal cholecystectomy		2 year
Secondary	pain		2 years
Secondary	quality of life		2 years