NCT00530998

Minimally Invasive Surgery: Using Natural Orfices

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Appendicitis
• Cholelithiasis
• Gallstones

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2007-09-18
• Last updated: 2020-03-10

Locations

1 site across 1 country: United States