Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic
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|ClinicalTrials.gov Identifier: NCT00963950|
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : January 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Biliary Colic||Procedure: transvaginal cholecystectomy Procedure: laparoscopic cholecystectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transvaginal Cholecystectomy|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||March 2014|
Experimental: Intervention group
Procedure: transvaginal cholecystectomy
Transvaginal approach to gallbladder removal.
Active Comparator: laparoscopic cholecystectomy
Laparoscopic cholecystectomy (4 port)
Procedure: laparoscopic cholecystectomy
- feasibility of transvaginal cholecystectomy [ Time Frame: 2 year ]
- pain [ Time Frame: 2 years ]
- quality of life [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963950
|Principal Investigator:||Kurt Roberts, MD||Yale University|