Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic

Transvaginal Cholecystectomy

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.

Study Overview

• Status: Completed
• Conditions: Biliary Colic
• Intervention / Treatment: Procedure: laparoscopic cholecystectomy; Procedure: transvaginal cholecystectomy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; transvaginal cholecystectomy	Procedure: transvaginal cholecystectomy; Transvaginal approach to gallbladder removal.
Active Comparator: laparoscopic cholecystectomy; Laparoscopic cholecystectomy (4 port)	Procedure: laparoscopic cholecystectomy; laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
feasibility of transvaginal cholecystectomy	2 year

Secondary Outcome Measures

Outcome Measure	Time Frame
quality of life	2 years
pain	2 years

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Kurt Roberts, MD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: August 20, 2009
• First Submitted That Met QC Criteria: August 21, 2009
• First Posted (Estimate): August 24, 2009

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: cholecystectomy
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: 0902004771

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No