Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial

NCT00710502 | Completed Phase 1

• 1 other identifier: 05626
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.realize the benefits of less invasive surgery by reducing the recovery time,
2. 2.experience less physical discomfort associated with traditional procedures
3. 3.have virtually no visible scarring following this type of surgery.

Conditions

Cholelithiasis

Keywords

Transvaginal; NOTES; Cholecystectomy; Laparoscopic

Outcome Measures

Primary Outcomes (1)

• Safety and Efficacy of Transvaginal NOTES cholecystectomy when compared to Laparoscopic cholecystectomy

  12 months

Secondary Outcomes (1)

• Short term outcomes of Transvaginal NOTES cholecystectomy when compared to Laparoscopic Cholecystectomy

  12 months

Study Arms (3)

1

EXPERIMENTAL

Transvaginal NOTES Cholecystectomy (Phase 1)

Procedure: Transvaginal NOTES cholecystectomy

2

ACTIVE COMPARATOR

Laparoscopic Cholecystectomy (Phase 2)

Procedure: Laparoscopic cholecystectomy

3

EXPERIMENTAL

Transvaginal NOTES cholecystectomy (Phase 2)

Procedure: Transvaginal NOTES cholecystectomy

Interventions

Transvaginal NOTES cholecystectomy PROCEDURE

Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy

Also known as: NOTES gallbladder removal, NOTES gallbladder surgery

1; 3

Laparoscopic cholecystectomy PROCEDURE

Under general anesthesia, patients will undergo standard Laparoscopic cholecystectomy

Also known as: Small incision gallbladder surgery

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who have contraindications prohibiting general anesthesia.
• Pregnancy.
• Previous abdominal or gynecological procedures.
• Uncontrollable medical or psychiatric conditions
• Elderly \> 65 y/o.
• Body Mass Index \> 35 mg/kg2.
• Complicated or acute cholecystitis.
• Elevation of liver function tests.
• Acute abdomen.
• Intra-abdominal abscess.
• Coagulopathy.
• Imperforated hymen.

Sponsors & Collaborators

• Universidad Juárez del Estado de Durango: lead
• Hospital Universitario La Paz: collaborator

Study Sites (1)

Universidad Juarez del Estado de Durango, Mexico

Durango, Durango, 34000, Mexico

Location

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Homero Rivas, MD

  Hospital de la Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 15, 2009

Record last verified: 2009-12

Locations

ME (1)