Feasibility of Transvaginal Cholecystectomy
Feasibility of Transvaginal Cholecystectomy
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.
As technologic innovations in medicine continue to advance, less intrusive operative
 procedures are being developed. Natural Orifice Transluminal Endoscopic Surgery (NOTES) may
 represent a less invasive approach to the abdominal cavity. The access to the abdominal
 cavity through natural orifices such as the vagina has the benefit of decreased
 somato-sensory innervation. This venue might confer less pain and operative stress to the
 patient. The transvaginal approach has been suggested as a new surgical approach to
 gallbladder surgery (cholecystectomy). Approximately 700 transvaginal cholecystectomy
 procedures have been performed in medical centers around the world so far. Anecdotal data
 suggest that the patients experience less pain postoperatively and half of them may not
 require any pain medication. Currently, introduction of this new operative approach outside
 of a research study is not supported by national nor international societies.

 We wish to demonstrate that the transvaginal approach is feasible for 10 patients with
 gallstone disease at Mayo Clinic Rochester (MCR).

 Methods: Female patients seen by consultants from the Division of General and
 Gastrointestinal Surgery, who have an appropriate indication for elective cholecystectomy,
 will be offered a cholecystectomy via the transvaginal approach. After patient enrollment,
 baseline demographics, questionnaires and blood draws will be obtained. The patient will
 undergo a laparoscopic assisted transvaginal cholecystectomy by a dedicated surgical team,
 consisting of a gynecologist, a minimally invasive surgeon and a gastroenterologist. This
 approach will utilize a 5-mm umbilical trocar and a posterior colpotomy. Standard
 laparoscopic and flexible endoscopic instrumentation will be utilized along with recently
 introduced long flexible-tip laparoscopic instrumentation to remove the gallbladder.
 Intraoperative parameters will be recorded. Postoperatively blood draws and questionnaires
 will be repeated at specific intervals.

 Data analysis will be mainly descriptive for this feasibility study. The collected material
 will serve as pilot data for a future comparative study of transvaginal cholecystectomy with
 standard laparoscopic cholecystectomy.
Inclusion criteria

 -  Female patients undergoing elective cholecystectomy for cholelithiasis.

 Exclusion criteria

 -  Male patients, patients <18 years or >65 years of age

 -  Pregnant patients

 -  Patients with prior pelvic surgery

 -  Patients with prior hepatobiliary surgery or other major abdominal surgery

 -  Patients with ASA class >3

 -  Patients with BMI >35

 -  Patients with risk factors for requiring an open cholecystectomy (e.g. possible
 gallbladder cancer, acute cholecystitis, jaundice)

 -  Patients who cannot provide consent for the study

 -  Patients not willing to participate in the study.

 -  Patients with common bile duct stones

 -  Patients with evidence of abdominal abscess or mass

 -  Patients with diffuse peritonitis

 -  Patients with a clinical diagnosis of sepsis

 -  Patients with coagulopathy or using anticoagulants or anti-platelet agents (aspirin up
 to 81mg/day acceptable)

 -  Patients with planned concurrent procedures

 -  Patients with a prior diagnosis of intra-abdominal adhesions

 -  Patients who are participating in any other investigational device or drug trial that
 has not yet completed the primary endpoint

 -  Patients with an enlarged uterus