Feasibility of Transvaginal Cholecystectomy

Summary

Today there are three different ways to remove a gallbladder with gallstones. Surgeons can remove the gallbladder through small incisions in the abdomen. This is called laparoscopic cholecystectomy. It is the current standard. It has replaced traditional open gallbladder surgery. Open gallbladder surgery is done with a large incision. A new way of removing the gallbladder in women is through the vagina. This is called transvaginal cholecystectomy. This study is being done to see if removing the gallbladder through the vagina will work for patients at Mayo Clinic Rochester. This is the first step of this research to test the procedure. In the future, other studies will examine the potential for less scarring and reduced pain. In this study the investigators will still make small incisions in the abdomen, they will be smaller than the standard procedure but you will still have some scars on your abdomen.

Some very early research reports say that some patients may have less pain with the transvaginal approach; however, the investigators do not know if the transvaginal route will have any effect on your overall health and quality of life.

This study will evaluate:

* Effectiveness of the surgery: ability to remove the gallbladder safely
* Effect of the operation on your body: change in pulse and blood pressure during the surgery, level of inflammation markers in your blood before and after the surgery
* Recovery from surgery in the hospital: how much pain you have, how much pain medication you need, how long you need to stay in the hospital, or nature of any surgical complications (problems)
* Overall recovery from surgery: general quality of life, abdominal symptoms

What is the new type of surgery?

The new type of surgery is called transvaginal cholecystectomy:

A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps the surgeons to remove your gallbladder through the vagina. The procedure to separate your gallbladder from your body will be assisted by instruments placed through your abdomen and instruments placed in your vagina. The surgeon will remove the gallbladder by passing it though your vagina.

Conditions

• Gallstones

Interventions

DEVICE

Transvaginal Cholecystectomy

A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps the surgeons to remove your gallbladder through the vagina. The procedure to separate your gallbladder from your body will be assisted by instruments placed through your abdomen and instruments placed in your vagina. The surgeon will remove the gallbladder by passing it though your vagina.

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Juliane Bingener-Casey, MD · Mayo Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2012-12-31

Completion

2012-12-31