Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial
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.
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Cholelithiasis
Intervention
Transvaginal NOTES cholecystectomy, Laparoscopic cholecystectomy
Location
Universidad Juarez del Estado de Durango, Mexico
Durango
Mexico
34000
Status
Completed
Source
North Texas Veterans Healthcare System
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00710502
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cholecystectomy, Laparoscopic
Excision of the gallbladder through an abdominal incision using a laparoscope.
Cholecystectomy
Surgical removal of the GALLBLADDER.
Lecture Notes
Works consisting of notes taken at the delivery or reading of a speech before an audience or class, usually given to instruct. (From Random House Unabridged Dictionary, 2d ed)
Sphincterotomy, Endoscopic
Incision of Oddi's sphincter or Vater's ampulla performed by inserting a sphincterotome through an endoscope (DUODENOSCOPE) often following retrograde cholangiography (CHOLANGIOPANCREATOGRAPHY, ENDOSCOPIC RETROGRADE). Endoscopic treatment by sphincterotomy is the preferred method of treatment for patients with retained or recurrent bile duct stones post-cholecystectomy, and for poor-surgical-risk patients that have the gallbladder still present.
Hemobilia
Hemorrhage in or through the BILIARY TRACT due to trauma, inflammation, CHOLELITHIASIS, vascular disease, or neoplasms.
Clinical Trials
Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Surgery
The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans a...
Transvaginal hybrid procedures are of interest as an available NOTES procedure for the clinical routine. The gynaecologists` experiences and the available studies report on low morbidity r...
Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.
Transvaginal hybrid procedures especially the transvaginal hybrid cholecystectomy are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated th...
Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy
Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. The insertion sites for th...
PubMed Articles
Spleen rupture: an unusual postoperative complication after laparoscopic cholecystectomy.
Laparoscopic cholecystectomy is the gold standard in the surgical treatment of symptomatic cholelithiasis and other benign gallbladder diseases. Laparoscopic cholecystectomy isn't devoid by some compl...
INTRODUCTION: A natural orifice transluminal endoscopic surgery (NOTES) approach offers the potential of reducing pain and convalescence after intra-abdominal operations. We present a single-instituti...
PURPOSE: In the recent past, access to the peritoneal cavity has involved primarily 'natural orifice transluminal' and 'single-port access' techniques, which are based on laparoscopy. The most frequen...
Venous thromboembolism after laparoscopic cholecystectomy: clinical burden and prevention.
BACKGROUND: The clinical benefit of prophylaxis for venous thromboembolism (VTE) in laparoscopic cholecystectomy is unclear. This study aimed to assess the clinical burden of VTE and the efficacy and...
First croatian transvaginal laparoscopically assisted cholecystectomies.
Background/Aims: The aim of this study was to determine the feasibility and technical aspects of a new endoluminal surgical procedure: transvaginal laparoscopically assisted endoscopic cholecystectomy...
