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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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT00530998
Study type Observational
Source University of California, San Diego
Contact
Status Completed
Phase
Start date September 2007
Completion date September 2019

See also
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