Transvaginal Appendectomy

Appendicitis Clinical Trial

Official title:

Transvaginal Appendectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806429
• Other study ID #: 0712003306
• Status: Completed
• Phase: N/A
• First received: December 2, 2008
• Last updated: October 13, 2017
• Start date: August 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the feasibility and safety of transvaginal appendectomy and determine and compare the postoperative pain and quality of life after surgery to standard laparoscopic transabdominal appendectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ultrasound or CT-based diagnosis of acute or chronic appendicitis

• ASA classification 1 or 2

Exclusion Criteria:

• BMI >35

• on Immunosuppressive meds or immunocompromised

• on blood thinners or aspirin or abnormal coagulation tests

• h/o ectopic pregnancy, PID or endometriosis

• prior open abdominal surgery or transvaginal surgery

• with diffuse peritonitis

• evidence of abscess

• retroflexed uterus

• non english speaking

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• transvaginal appendectomy
patient undergoes transvaginal appendectomy

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of transvaginal appendectomy		1 year
Secondary	pain		1 year
Secondary	quality of life		1 year