Minimally Invasive Surgery: Using Natural Orfices - Full Text View

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00530998

Purpose

A research study to find out more about an investigational approach to perform surgery that has not been done in humans before at this institution. Normally this type of surgery would be done laparoscopically or open. Laparoscopic surgery is where the doctor would make several (3-6) small opening in the abdomen; places a camera and other instruments and removes the gallbladder through a small incision in the lower right abdomen. Open surgery is where the doctor makes approximately a 6 inch incision into the abdomen and removes the gallbladder. This investigational procedure is called Natural Orifice Translumenal Endoscopic Surgery (NOTES). This means that surgery would be done through the mouth, vagina or rectum. In this study, the doctor will perform this investigational method of surgery through the vagina.

Condition	Intervention
Appendicitis Cholelithiasis Gallstones	Procedure: Transvaginal Appendectomy Procedure: Transvaginal Cholecystectomy

MedlinePlus related topics: Appendicitis Endoscopy Gallstones

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy

Further study details as provided by University of California, San Diego:

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: Yes ]

Estimated Enrollment:	30
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Group #1 NOTES Appendectomy - Transvaginal approach	Procedure: Transvaginal Appendectomy The appendix will be removed via an incision in the vagina.
2: Active Comparator Group #2 NOTES Cholecystectomy - Transvaginal approach	Procedure: Transvaginal Cholecystectomy The gallbladder will be removed via 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:

Group #1 NOTES Appendectomy - Transvaginal approach:

Inclusion criteria for transvaginal appendectomy:

Females between the ages of 18-50
Clinical diagnosis of appendicitis
Emergency room evaluation within 48 hours of the onset of pain
ASA Classification 1

Exclusion criteria for transvaginal appendectomy:

Pregnant women (need to have negative icon in ER)
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 with prior laparoscopic surgery will be included.
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.

Group #2 NOTES Cholecystectomy - Transvaginal approach:

Inclusion criteria for transvaginal cholecystectomy:

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

Exclusion criteria for 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 prior laparoscopic surgery will be included.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530998

Contacts

Contact: Julie A Bosia, BSN

619-471-0447

misresearch@ucsd.edu

Locations

United States, California
University of California, San Diego	Recruiting
San Diego, California, United States, 92103
Principal Investigator: Santiago Horgan, MD

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:	Santiago Horgan, MD	University of California, San Diego
Study Chair:	Mark A Talamini, MD	University of California, San Diego

More Information

Responsible Party:	University of California, San Diego ( Santiago Horgan, MD )
Study ID Numbers:	071115
Study First Received:	September 17, 2007
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00530998
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

appendicitis
cholelithiasis
Gallstones

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases
Cholelithiasis
Gastrointestinal Diseases

Gallstones
Biliary Tract Diseases
Appendicitis
Calculi
Intestinal Diseases
Gastroenteritis

Additional relevant MeSH terms:

Cecal Diseases

ClinicalTrials.gov processed this record on January 16, 2009