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OpenTrials
Completed

NCT Number: NCT00963950

Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transvaginal Cholecystectomy

Procedure

Transvaginal approach to gallbladder removal.

Laparoscopic cholecystectomy

Procedure

laparoscopic cholecystectomy

Primary outcomes

  1. feasibility of transvaginal cholecystectomy

    Time frame: 2 year

Secondary outcomes

  1. pain

    Time frame: 2 years

  2. quality of life

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Transvaginal Cholecystectomy

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Aug 24, 2009
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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