Appendicitis Clinical Trial
Official title:
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.
n/a
Status | Clinical Trial | Phase | |
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Completed |
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