Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Not Applicable

Withdrawn

• Conditions: Gallstones; Appendicitis; Pelvic Pain
• Interventions: Procedure: Endoscopic Cholecystectomy; Procedure: Endoscopic Appendectomy; Procedure: Endoscopic Peritoneoscopy

• 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• Status: WITHDRAWN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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic Cholecystectomy	Endoscopic Cholecystectomy	20 patients in this arm will undergo cholecystectomy, or removal of the gallbladder, through this experimental approach. This arm will compose of patients with symptomatic gallstones (cholelithiasis).
Endoscopic Appendectomy	Endoscopic Appendectomy	Participants will with chronic appendicitis will undergo appendectomy through this experimental approach.
Endoscopic Peritoneoscopy	Endoscopic Peritoneoscopy	20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication.

Primary Outcome Measures

Name	Time	Method
Technical success	intra-operative
Complication	1 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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