Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic
Recruitment status was: Enrolling by invitation
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.
|Biliary Colic||Procedure: transvaginal cholecystectomy Procedure: laparoscopic cholecystectomy||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Transvaginal Cholecystectomy|
- feasibility of transvaginal cholecystectomy [ Time Frame: 2 year ]
- pain [ Time Frame: 2 years ]
- quality of life [ Time Frame: 2 years ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Intervention group
Procedure: transvaginal cholecystectomy
Transvaginal approach to gallbladder removal.
Active Comparator: laparoscopic cholecystectomy
Laparoscopic cholecystectomy (4 port)
Procedure: laparoscopic cholecystectomy
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963950
|Principal Investigator:||Kurt Roberts, MD||Yale University|