Minimally Invasive Surgery: Using Natural Orfices (NOTES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00530998
First received: September 17, 2007
Last updated: March 25, 2015
Last verified: March 2015

September 17, 2007
March 25, 2015
September 2007
September 2017   (final data collection date for primary outcome measure)
To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 evaluate pain associated with the transvaginal approach (through data collection). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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

This is an observational study of pain and outcomes from females undergoing transvaginal NOTES removal of their appendix or gallbladder. Female subjects who elect to have a transvaginal NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following:

  • Subjects will complete a 7 day pain/temperature log after surgery
  • Subjects will complete a standardized sexual function questionnaire (Female Sexual Function Index) prior to surgery and 6 months after surgery
  • Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction

Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Group #1: NOTES Appendectomy - Transvaginal approach:

Subjects will be female between the ages of 18-75 who present to the emergency room and are subsequently diagnosed with acute appendicitis. Following diagnosis, investigators will determine if the procedure can be completed via the transvaginal approach. If the patient satisfies the listed criteria then researchers will present study information and offer participation.

Group # 2: NOTES Cholecystectomy - Transvaginal approach:

Female subjects, between the ages of 18-75 who present in the UCSD surgery clinic for elective cholecystectomy will be offered participation in this study.

  • 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.
  • 1
    Group #1 NOTES Appendectomy - Transvaginal approach
    Intervention: Procedure: Transvaginal Appendectomy
  • 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
120
September 2017
September 2017   (final data collection date for primary outcome measure)

Inclusion criteria for transvaginal appendectomy:

  1. Females between the ages of 18-75
  2. Clinical diagnosis of appendicitis
  3. Emergency room evaluation within 36 hours of the onset of pain
  4. ASA Classification 1
  5. Mentally competent to give informed consent
  6. Scheduled to undergo a transvaginal NOTES appendectomy.

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 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. Patients on blood thinners or aspirin or abnormal blood coagulation tests

Inclusion criteria for transvaginal cholecystectomy:

  1. Females between the ages of 18 and 75
  2. Diagnosis of gallstone disease which requires cholecystectomy
  3. ASA class 1
  4. Mentally competent to give informed consent
  5. Scheduled to undergo a transvaginal NOTES cholecystectomy

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 transvaginal surgery. Patients with prior laparoscopic surgery will be included.
  7. Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis
  8. Patients with known common bile duct stones
  9. Patients on blood thinners or aspirin or abnormal blood coagulation tests
Female
18 Years to 75 Years
No
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
United States
 
NCT00530998
071115, 140015
No
Santiago Horgan, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Santiago Horgan, MD University of California, San Diego
University of California, San Diego
March 2015

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