Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial

This study has been completed.
Sponsor:
Collaborator:
Hospital Universitario La Paz
Information provided by:
North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00710502
First received: July 2, 2008
Last updated: December 14, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Cholelithiasis
Procedure: Transvaginal NOTES cholecystectomy
Procedure: Laparoscopic cholecystectomy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transvaginal Natural Orifice Translumenal and Endoscopic Surgery (NOTES) Cholecystectomy vs. Laparoscopic Cholecystectomy: Phase I/II Clinical Trial

Resource links provided by NLM:


Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • Safety and Efficacy of Transvaginal NOTES cholecystectomy when compared to Laparoscopic cholecystectomy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Short term outcomes of Transvaginal NOTES cholecystectomy when compared to Laparoscopic Cholecystectomy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Transvaginal NOTES Cholecystectomy (Phase 1)
Procedure: Transvaginal NOTES cholecystectomy
Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
Other Names:
  • NOTES gallbladder removal
  • NOTES gallbladder surgery
Active Comparator: 2
Laparoscopic Cholecystectomy (Phase 2)
Procedure: Laparoscopic cholecystectomy
Under general anesthesia, patients will undergo standard Laparoscopic cholecystectomy
Other Name: Small incision gallbladder surgery
Experimental: 3
Transvaginal NOTES cholecystectomy (Phase 2)
Procedure: Transvaginal NOTES cholecystectomy
Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
Other Names:
  • NOTES gallbladder removal
  • NOTES gallbladder surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult (> 18 years old) female patients residents of Durango Mexico.
  2. Patients who undergo elective surgery.
  3. Patients with ultrasound documented symptomatic cholelithiasis, gallbladder polyps of biliary dyskinesia.
  4. Patients capable of giving written informed consent for the study.

Exclusion Criteria:

  1. Patients who have contraindications prohibiting general anesthesia.
  2. Pregnancy.
  3. Previous abdominal or gynecological procedures.
  4. Uncontrollable medical or psychiatric conditions
  5. Elderly > 65 y/o.
  6. Body Mass Index > 35 mg/kg2.
  7. Complicated or acute cholecystitis.
  8. Elevation of liver function tests.
  9. Acute abdomen.
  10. Intra-abdominal abscess.
  11. Coagulopathy.
  12. Imperforated hymen.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710502

Locations
Mexico
Universidad Juarez del Estado de Durango, Mexico
Durango, Mexico, 34000
Sponsors and Collaborators
Universidad Juarez Durango
Hospital Universitario La Paz
Investigators
Principal Investigator: Homero Rivas, MD Hospital de la Paz
  More Information

No publications provided

Responsible Party: Homero Rivas MD, Hospital de la Paz
ClinicalTrials.gov Identifier: NCT00710502     History of Changes
Other Study ID Numbers: 05626
Study First Received: July 2, 2008
Last Updated: December 14, 2009
Health Authority: Mexico: Ethics Committee
United States: Federal Government

Keywords provided by North Texas Veterans Healthcare System:
Transvaginal
NOTES
Cholecystectomy
Laparoscopic

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 24, 2014