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Minimally Invasive Surgery: Using Natural Orfices (NOTES)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00530998
First received: September 17, 2007
Last updated: July 14, 2011
Last verified: July 2011

September 17, 2007
July 14, 2011
September 2007
September 2014   (final data collection date for primary outcome measure)
To assess the safety and efficacy of a novel approach to minimally invasive surgical techniques [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES [ Time Frame: Continuous ]
Complete list of historical versions of study NCT00530998 on ClinicalTrials.gov Archive Site
To assess pain associated with transvaginal approach [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
TO ASSES PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH [ Time Frame: Continuous ]
Not Provided
Not Provided
 
Minimally Invasive Surgery: Using Natural Orfices
Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Appendicitis
  • Cholelithiasis
  • Gallstones
  • Procedure: Transvaginal Appendectomy
    The appendix will be removed via an incision in the vagina.
  • Procedure: Transvaginal Cholecystectomy
    The gallbladder will be removed via an incision in the vagina.
  • Active Comparator: 1
    Group #1 NOTES Appendectomy - Transvaginal approach
    Intervention: Procedure: Transvaginal Appendectomy
  • Active Comparator: 2
    Group #2 NOTES Cholecystectomy - Transvaginal approach
    Intervention: Procedure: Transvaginal Cholecystectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Group #1 NOTES Appendectomy - Transvaginal approach:

Inclusion criteria for transvaginal appendectomy:

  1. Females between the ages of 18-65.
  2. Clinical diagnosis of appendicitis
  3. Emergency room evaluation within 48 hours of the onset of pain
  4. ASA Classification 1

Exclusion criteria for transvaginal appendectomy:

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

Group #2 NOTES Cholecystectomy - Transvaginal approach:

Inclusion criteria for transvaginal cholecystectomy:

  1. Females between the ages of 18 and 65
  2. Diagnosis of gallstone disease which requires cholecystectomy
  3. ASA class 1

Exclusion criteria for 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. Patients with prior laparoscopic surgery will be included.
  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
Female
18 Years to 65 Years
No
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
Contact: Cece Echon, RN, MSN 619-471-0447 misresearch@ucsd.edu
United States
 
NCT00530998
071115
Yes
Santiago Horgan, MD, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Santiago Horgan, MD University of California, San Diego
Study Chair: Mark A Talamini, MD University of California, San Diego
University of California, San Diego
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP