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Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial

NCT ID: NCT00710502

Last Updated: 2009-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Cholelithiasis

Keywords

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Transvaginal NOTES Cholecystectomy Laparoscopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Transvaginal NOTES Cholecystectomy (Phase 1)

Group Type EXPERIMENTAL

Transvaginal NOTES cholecystectomy

Intervention Type PROCEDURE

Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy

2

Laparoscopic Cholecystectomy (Phase 2)

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Under general anesthesia, patients will undergo standard Laparoscopic cholecystectomy

3

Transvaginal NOTES cholecystectomy (Phase 2)

Group Type EXPERIMENTAL

Transvaginal NOTES cholecystectomy

Intervention Type PROCEDURE

Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy

Interventions

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Transvaginal NOTES cholecystectomy

Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy

Under general anesthesia, patients will undergo standard Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Other Intervention Names

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NOTES gallbladder removal NOTES gallbladder surgery Small incision gallbladder surgery

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario La Paz

OTHER

Sponsor Role collaborator

Universidad Juárez del Estado de Durango

OTHER

Sponsor Role lead

Responsible Party

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Hospital de la Paz

Principal Investigators

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Homero Rivas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de la Paz

Locations

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Universidad Juarez del Estado de Durango, Mexico

Durango, Durango, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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05626

Identifier Type: -

Identifier Source: org_study_id