Minimally Invasive Surgery: Using Natural Orfices

Completed

Conditions studied: Appendicitis, Cholelithiasis, Gallstones

In brief

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.

Key facts

Study ID
NCT00530998
Run by
University of California, San Diego
People needed
120
Starts
2007-09-01
Expected to finish
2019-09-01
Last updated by the study team
2020-03-10

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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