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NOTES Transvaginal Cholecystectomy and Appendectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00552162
First received: October 31, 2007
Last updated: May 12, 2008
Last verified: May 2008
History of Changes
  Purpose

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.


Condition Intervention
Gallbladder Diseases
Appendectomy
 Procedure: NOTES Transvaginal Cholecystectomy
Procedure: NOTES Transvaginal Appendectomy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NOTES Transvaginal Cholecystectomy and Appendectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES [ Time Frame: continuous ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH [ Time Frame: continuous ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2008
Estimated Study Completion Date: July 2009
Arms Assigned Interventions
Active Comparator: 1
NOTES Transvaginal cholecystectomy The gallbladder will be dissected free and will be removed through an incision in the vagina.
 Procedure: NOTES Transvaginal Cholecystectomy
The gallbladder will be dissected free and will be removed through an incision in the vagina.
Active Comparator: 2
NOTES Transvaginal Appendectomy. The appendix will be dissected free and will be removed through an incision in the vagina.
 Procedure: NOTES Transvaginal Appendectomy
The appendix will be dissected free and will be removed through an incision in the vagina.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for group #1 Transvaginal cholecystectomy:

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

Exclusion Criteria for group #1 Transvaginal cholecystectomy:

  1. Pregnant women
  2. Morbidly obese patients (BMI > 35)
  3. Patients who are taking immunosuppressive medications and/or immunocompromised
  4. Patients with severe medical comorbidities will be excluded.
  5. Patients with a presumed gallbladder polyps, mass or tumor
  6. Patients with a history of prior open abdominal or transvaginal surgery.
  7. Patients with a prior history of peritoneal or vaginal trauma
  8. Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis
  9. Patients with known common bile duct stones
  10. Patients on blood thinners or aspirin or abnormal blood coagulation tests

Inclusion Criteria for group #2 Transvaginal appendectomy:

  1. Clinical diagnosis of appendicitis
  2. Emergency room evaluation within 36 hours of the onset of pain
  3. ASA Classification

Exclusion Criteria for group #2 Transvaginal appendectomy:

  1. pregnant women
  2. Morbidly obese patients (BMI >35)
  3. Patients who are taking immunosuppressive medications or are immunocompromised
  4. Patients with evidence of an abdominal abscess or mass
  5. Patients who present with a clinical diagnosis of sepsis or peritonitis
  6. Patients who have a history of prior open abdominal surgery or prior transvaginal surgery.
  7. Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
  8. Patients with diffuse peritonitis on clinical exam
  9. Previous trauma to the perineal area
  10. Patients on blood thinners or aspirin or abnormal blood coagulation tests
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552162

Contacts
Contact: Yoav Mintz, MD 972-2-6777111 ymintz@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Active, not recruiting
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yoav Mintz, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Yoav Mintz MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00552162     History of Changes
Other Study ID Numbers: NOTES HMO-CTIL, 21-2.11.07
Study First Received: October 31, 2007
Last Updated: May 12, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013