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Minimally Invasive Surgery: Using Natural Orfices

NCT00530998 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2020-03-10

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Transvaginal Appendectomy

The appendix will be removed via an incision in the vagina.

PROCEDURE

Transvaginal Cholecystectomy

The gallbladder will be removed via an incision in the vagina.

Sponsors & Collaborators

Principal Investigators

  • Santiago Horgan, MD · University of California, San Diego

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00530998 on ClinicalTrials.gov