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Clinical Trials/NCT00530998
NCT00530998
Completed
Not Applicable

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

University of California, San Diego1 site in 1 country120 target enrollmentSeptember 2007

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.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
September 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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