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CompletedNCT00963950Updated Jan 17, 2018

Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic

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

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
Female
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Study summary

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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Conditions studied

  • Biliary Colic

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Keywords

  • cholecystectomy
03

In context

Colic

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Intervention group

    transvaginal cholecystectomy

    Procedure: transvaginal cholecystectomy

  • Active comparator
    laparoscopic cholecystectomy

    Laparoscopic cholecystectomy (4 port)

    Procedure: laparoscopic cholecystectomy

Interventions

  • Proceduretransvaginal cholecystectomy

    Transvaginal approach to gallbladder removal.

  • Procedurelaparoscopic cholecystectomy

    laparoscopic cholecystectomy

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Solomon D, Shariff AH, Silasi DA, Duffy AJ, Bell RL, Roberts KE. Transvaginal cholecystectomy versus single-incision laparoscopic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective cohort study. Surg Endosc. 2012 Oct;26(10):2823-7. doi: 10.1007/s00464-012-2253-0. Epub 2012 May 2. PubMed 22549370 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00963950
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Aug 24, 2009
Start date
Aug 2009
Primary completion
Sep 2013
Completion
Mar 2014
Last update
Jan 17, 2018

Study contacts

Kurt Roberts, MD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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