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Transvaginal Appendectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by Yale University.
Recruitment status was:  Recruiting
Information provided by:
Yale University Identifier:
First received: December 2, 2008
Last updated: December 8, 2008
Last verified: December 2008
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 Intervention
Appendicitis Procedure: transvaginal appendectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transvaginal Appendectomy

Resource links provided by NLM:

Further study details as provided by Yale University:

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

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

Estimated Enrollment: 20
Study Start Date: August 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
transvaginal appendectomy
Procedure: transvaginal appendectomy
patient undergoes transvaginal appendectomy
No Intervention: 2


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00806429

Contact: Kurt E Roberts, MD 2037649060

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kurt Roberts, MD / Primary Investigator, Yale School of Medicine Identifier: NCT00806429     History of Changes
Other Study ID Numbers: 0712003306
Study First Received: December 2, 2008
Last Updated: December 8, 2008

Keywords provided by Yale University:
natural orifice transluminal surgery

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases processed this record on September 21, 2017