Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Biliary Colic |
Procedure: transvaginal cholecystectomy Procedure: laparoscopic cholecystectomy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Transvaginal Cholecystectomy |
- feasibility of transvaginal cholecystectomy [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
- pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention group
transvaginal cholecystectomy
|
Procedure: transvaginal cholecystectomy
Transvaginal approach to gallbladder removal.
Other Name: transvaginal cholecystectomy
|
|
Active Comparator: laparoscopic cholecystectomy
Laparoscopic cholecystectomy (4 port)
|
Procedure: laparoscopic cholecystectomy
laparoscopic cholecystectomy
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided by Yale University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kurt Roberts, Asst. Prof. GI Surgery, Yale University |
| ClinicalTrials.gov Identifier: | NCT00963950 History of Changes |
| Other Study ID Numbers: | 0902004771 |
| Study First Received: | August 20, 2009 |
| Last Updated: | April 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
cholecystectomy |
Additional relevant MeSH terms:
|
Colic Abdominal Pain Pain Signs and Symptoms Signs and Symptoms, Digestive |
ClinicalTrials.gov processed this record on May 19, 2013