Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial

December 14, 2009 updated by: Universidad Juárez del Estado de Durango

Transvaginal Natural Orifice Translumenal and Endoscopic Surgery (NOTES) Cholecystectomy vs. Laparoscopic Cholecystectomy: Phase I/II Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Durango, Mexico, 34000
        • Universidad Juarez del Estado de Durango, Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Efficacy of Transvaginal NOTES cholecystectomy when compared to Laparoscopic cholecystectomy
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Short term outcomes of Transvaginal NOTES cholecystectomy when compared to Laparoscopic Cholecystectomy
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Juárez del Estado de Durango

Collaborators

Hospital Universitario La Paz

Investigators

  • Principal Investigator: Homero Rivas, MD, Hospital de La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (Estimate)

July 4, 2008

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 14, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05626

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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