Minimally Invasive Surgery: Using Natural Orfices

Appendicitis Clinical Trial

— NOTES  

Official title:

Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530998
• Other study ID #: 071115, 140015
• Status: Completed
• Start date: September 2007
• Est. completion date: September 2019

Study information

• Verified date: March 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Transvaginal Appendectomy
The appendix will be removed via an incision in the vagina.
• Transvaginal Cholecystectomy
The gallbladder will be removed via an incision in the vagina.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection).		1 year
Secondary	To evaluate pain associated with the transvaginal approach (through data collection).		1 year