An interventional study of transvaginal cholecystectomy and laparoscopic cholecystectomy in Biliary Colic, sponsored by Yale University. Completed. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-01-17.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
148 studies on the registry are indexed under Colic; 21 are open to participants now.
This study's enrollment of 30 is below the median of 88 across 122 interventional studies indexed under Colic.
Browse Colic studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
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Exclusion Criteria:
transvaginal cholecystectomy
Procedure: transvaginal cholecystectomy
Laparoscopic cholecystectomy (4 port)
Procedure: laparoscopic cholecystectomy
Transvaginal approach to gallbladder removal.
laparoscopic cholecystectomy
feasibility of transvaginal cholecystectomy
Time frame: 2 year
pain
Time frame: 2 years
quality of life
Time frame: 2 years
No study locations are listed for this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Yale University