Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Appendicitis Clinical Trial

Official title:

Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01039129
• Other study ID #: SLR IRB#09-136
• Status: Withdrawn
• Phase: N/A
• First received: December 22, 2009
• Last updated: August 19, 2015
• Start date: December 2009
• Est. completion date: October 2012

Study information

• Verified date: August 2015
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis
• Gallstones
• Pelvic Pain

Intervention

Procedure:
• Endoscopic Cholecystectomy
An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus.
• Endoscopic Appendectomy
An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus
• Endoscopic Peritoneoscopy
A diagnostic peritoneoscopy with or without biopsy for any indication

Locations

Country	Name	City	State
United States	St. Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success		intra-operative	No
Primary	Complication		1 month	Yes
Secondary	Operative time		intra-operative	No
Secondary	Sexual function		1 year	No