Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Not Applicable

Withdrawn

• Conditions: Gallstones; Appendicitis; Pelvic Pain

• Registration Number: NCT01039129
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief Summary

The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-24
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Chronic or early appendicitis
• Symptomatic gallstones
• Suspicious abdominal mass/nodule
• Female
• Age 18-60 years
• ASA Class I or II

Exclusion Criteria

• Pregnant women
• History of previous abdominal, pelvic, or vaginal surgery
• History of previous abdominal or pelvic radiation therapy
• History of fibroid uterus
• History of endometriosis
• History of large ovarian cyst
• History of unexplained vaginal bleeding or dyspareunia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Technical success	intra-operative
Complication	1 month

Secondary Outcome Measures

Name	Time	Method
Operative time	intra-operative
Sexual function	1 year

Trial Locations

Locations (1)

St. Luke's-Roosevelt Hospital Center; 🇺🇸 New York, New York, United States