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Transvaginal Appendectomy

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ClinicalTrials.gov Identifier: NCT00806429
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : October 17, 2017
Sponsor:
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
Appendicitis Procedure: transvaginal appendectomy

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
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

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

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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

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

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 Posted: December 10, 2008    Key Record Dates
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