NOTES Transvaginal Cholecystectomy and Appendectomy

NCT00552162 | Completed

• 2 other identifiers: NOTES HMO-CTIL21-2.11.07
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving area of preclinical research and several groups worldwide are developing this surgical approach together with industry support. In this new surgical technique, abdominal operations are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal cavity instead of incisions on the abdominal wall. NOTES offers all the advantages of minimally invasive surgery (MIS) and also completely eliminates trauma to the abdominal wall and the numerous complications of abdominal wall incisions. A NOTES procedure eliminates any visible scar and could also potentially reduce post operative pain due to the elimination of abdominal wall trauma. In this trial we intend to operate healthy women who need to undergo cholecystectomy or appendectomy. The operations will be performed through the vagina as the access port to the peritoneum and it will be monitored with laparoscopic vision for safety reasons.

Conditions

Gallbladder Diseases; Appendicitis

Outcome Measures

Primary Outcomes (1)

• TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES

  continuous

Secondary Outcomes (1)

• TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH

  continuous

Study Arms (2)

1

ACTIVE COMPARATOR

NOTES Transvaginal cholecystectomy The gallbladder will be dissected free and will be removed through an incision in the vagina.

Procedure: NOTES Transvaginal Cholecystectomy

2

ACTIVE COMPARATOR

NOTES Transvaginal Appendectomy. The appendix will be dissected free and will be removed through an incision in the vagina.

Procedure: NOTES Transvaginal Appendectomy

Interventions

NOTES Transvaginal Cholecystectomy PROCEDURE

The gallbladder will be dissected free and will be removed through an incision in the vagina.

1

NOTES Transvaginal Appendectomy PROCEDURE

The appendix will be dissected free and will be removed through an incision in the vagina.

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females between the ages of 18 and 50
• Diagnosis of gallstone disease which requires cholecystectomy
• ASA class 1

You may not qualify if:

• Pregnant women
• Morbidly obese patients (BMI \> 35)
• Patients who are taking immunosuppressive medications and/or immunocompromised
• Patients with severe medical comorbidities will be excluded.
• Patients with a presumed gallbladder polyps, mass or tumor
• Patients with a history of prior open abdominal or transvaginal surgery.
• Patients with a prior history of peritoneal or vaginal trauma
• Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis
• Patients with known common bile duct stones
• Patients on blood thinners or aspirin or abnormal blood coagulation tests
• Clinical diagnosis of appendicitis
• Emergency room evaluation within 36 hours of the onset of pain
• ASA Classification
• pregnant women
• Morbidly obese patients (BMI \>35)

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (2)

Hadassah Medical Center

Jerusalem, 12000, Israel

Location

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Gallbladder Diseases; Appendicitis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Yoav Mintz, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 1, 2007
• Study Start: June 1, 2008
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 30, 2020

Record last verified: 2016-04

Locations

IL (2)