Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Kurt Roberts, Yale University
ClinicalTrials.gov Identifier:
NCT00963950
First received: August 20, 2009
Last updated: April 9, 2012
Last verified: April 2012
  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

Further study details as provided by Yale University:

Primary Outcome Measures:
  • feasibility of transvaginal cholecystectomy [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963950

Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Kurt Roberts, MD Yale University
  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 October 23, 2014