Transvaginal Appendectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00806429
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : October 17, 2017
Information provided by (Responsible Party):
Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Appendicitis Procedure: transvaginal appendectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transvaginal Appendectomy
Study Start Date : August 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Experimental: 1
transvaginal appendectomy
Procedure: transvaginal appendectomy
patient undergoes transvaginal appendectomy

No Intervention: 2

Primary Outcome Measures :
  1. feasibility of transvaginal appendectomy [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. pain [ Time Frame: 1 year ]
  2. quality of life [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00806429

United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Principal Investigator: Kurt E Roberts, MD Yale School of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yale University Identifier: NCT00806429     History of Changes
Other Study ID Numbers: 0712003306
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: January 2012

Keywords provided by Yale University:
natural orifice transluminal surgery

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases