Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Appendicitis
- Sponsor
- University of California, San Diego
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection).
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Santiago Horgan
Professor of Surgery
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection).
Time Frame: 1 year
Secondary Outcomes
- To evaluate pain associated with the transvaginal approach (through data collection).(1 year)