Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cholecystectomy is one of the most common general surgery procedures performed in the US
      today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract
      disease has been estimated to cost U.S. healthcare $5 billion/year. Laparoscopic
      cholecystectomy was introduced in the early 1990s and has become the standard surgical
      approach for the treatment of gallbladder disease. More than 500,000 cholecystectomy
      procedures are performed in the US every year. Laparoscopic cholecystectomy is now performed
      as an outpatient basis and is related to a very low complication rate. Laparoscopic
      cholecystectomy requires the use of multiple trocar incisions.

      Natural Orifice Translumenal Endoscopic Surgery(NOTES) is a new type of surgical procedure
      currently being studied around the world. The idea of NOTES was developed several years ago
      in response to the concepts that patients would

        1. realize the benefits of less invasive surgery by reducing the recovery time,

        2. experience less physical discomfort associated with traditional procedures

        3. have virtually no visible scarring following this type of surgery.

      All of these advantages have spurred research and investigation forward, encouraging
      physicians and researchers to develop new equipment and techniques to use during NOTES
      procedures. Although the Natural Orifice Translumenal Endoscopic Surgery approach may hold
      tremendous potential, there are many issues that need to be addressed before this technique
      is introduced into clinical care.

      The purpose of this study is to determine the safety, feasibility and short-term clinical
      outcomes (Phase I trial) of transvaginal NOTES cholecystectomy in female patients with
      symptomatic cholelithiasis and compare it to Laparoscopic Cholecystectomy (Phase II).

      Hypothesis 1: Transvaginal NOTES cholecystectomy is safe and feasible in female patients with
      symptomatic cholelithiasis.

      Hypothesis 2: The short term outcomes of Transvaginal NOTES cholecystectomy are comparable to
      Laparoscopic Cholecystectomy in female patients with symptomatic cholelithiasis.

      Aim 1: Determine the safety of Transvaginal NOTES cholecystectomy. Aim 2: Determine the
      feasibility of Transvaginal NOTES cholecystectomy. Aim 3: Determine the short-term outcomes
      of Transvaginal NOTES cholecystectomy. Aim 4: Compare the short-term outcomes of Transvaginal
      NOTES cholecystectomy to Laparoscopic cholecystectomy.
    

Detailed description: 
      Most recently, surgeons and endoscopists have focused on NOTES cholecystectomy. Access to the
      abdominal cavity to perform NOTES procedures has been obtained by transgastric, transvaginal,
      transvesical and transrectal approaches. The first successful NOTES procedure in humans was
      an appendectomy in India. Transvaginal NOTES cholecystectomy has been successfully performed
      and reported in a handful of cases in the US, Europe and South America. However, to date,
      there is lack of clinical trials that demonstrate the safety and feasibility of Transvaginal
      NOTES cholecystectomy in a larger group of patients.
    

Intervention name(s): Transvaginal NOTES cholecystectomy; Laparoscopic cholecystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy; Under general anesthesia, patients will undergo standard Laparoscopic cholecystectomy
Other intervention name(s): NOTES gallbladder removal; NOTES gallbladder surgery; Small incision gallbladder surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transvaginal; NOTES; Cholecystectomy; Laparoscopic