Minimally Invasive Surgery: Using Natural Orfices



Status:Recruiting
Conditions:Other Indications, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:18 - 75
Updated:5/3/2018
Start Date:September 2007
End Date:September 2019
Contact:Sarah Lazar, MPH
Email:misresearch@ucsd.edu
Phone:619-471-0447

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
University of California, San Diego
San Diego, California 92093
Principal Investigator: Santiago Horgan, MD
?
mi
from
San Diego, CA
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