NOTES Transvaginal Cholecystectomy and Appendectomy - Full Text View

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00552162

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

MedlinePlus related topics: Gallbladder Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	NOTES Transvaginal Cholecystectomy and Appendectomy

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

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

Exclusion Criteria for group #1 Transvaginal cholecystectomy:

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

Inclusion Criteria for group #2 Transvaginal appendectomy:

Clinical diagnosis of appendicitis
Emergency room evaluation within 36 hours of the onset of pain
ASA Classification

Exclusion Criteria for group #2 Transvaginal appendectomy:

pregnant women
Morbidly obese patients (BMI >35)
Patients who are taking immunosuppressive medications or are immunocompromised
Patients with evidence of an abdominal abscess or mass
Patients who present with a clinical diagnosis of sepsis or peritonitis
Patients who have a history of prior open abdominal surgery or prior transvaginal surgery.
Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
Patients with diffuse peritonitis on clinical exam
Previous trauma to the perineal area
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
Jerusalem, Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Yoav Mintz, MD

Hadassah Medical Organization, Jerusalem, Israel

More Information

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

Study placed in the following topic categories:

Gallbladder Diseases
Digestive System Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on January 15, 2009