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Transvaginal Appendectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00806429
First Posted: December 10, 2008
Last Update Posted: October 17, 2017
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.
Information provided by (Responsible Party):
Yale University
  Purpose
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 ]

Enrollment: 20
Study Start Date: August 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (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

  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00806429


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00806429     History of Changes
Other Study ID Numbers: 0712003306
First Submitted: December 2, 2008
First Posted: December 10, 2008
Last Update Posted: October 17, 2017
Last Verified: January 2012

Keywords provided by Yale University:
appendicitis
surgery
laparoscopy
natural orifice transluminal surgery

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