Minimally Invasive Surgery: Using Natural Orfices (NOTES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by University of California, San Diego
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
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy

Resource links provided by NLM:


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: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess pain associated with transvaginal approach [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2007
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Group #1 NOTES Appendectomy - Transvaginal approach
Procedure: Transvaginal Appendectomy
The appendix will be removed via an incision in the vagina.
Active Comparator: 2
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 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
Contact: Cece Echon, RN, MSN 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

No publications provided

Responsible Party: Santiago Horgan, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00530998     History of Changes
Other Study ID Numbers: 071115
Study First Received: September 17, 2007
Last Updated: July 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
appendicitis
cholelithiasis
Gallstones

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Cholelithiasis
Cholecystolithiasis
Gallstones
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014