Minimally Invasive Surgery: Using Natural Orfices

Completed

• Conditions: Appendicitis; Gallstones; Cholelithiasis
• Interventions: Procedure: Transvaginal Appendectomy; Procedure: Transvaginal Cholecystectomy

• Registration Number: NCT00530998
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-17
• Study First Submitted QC: 2007-09-17
• Study First Posted: 2007-09-18
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-08
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Transvaginal Appendectomy	Group #1 NOTES Appendectomy - Transvaginal approach
2	Transvaginal Cholecystectomy	Group #2 NOTES Cholecystectomy - Transvaginal approach

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection).	1 year

Secondary Outcome Measures

Name	Time	Method
To evaluate pain associated with the transvaginal approach (through data collection).	1 year

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States