Transvaginal Appendectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00806429
First received: December 2, 2008
Last updated: December 8, 2008
Last verified: December 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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 ClinicalTrials.gov identifier: NCT00806429

Contacts
Contact: Kurt E Roberts, MD 2037649060 kurt.roberts@yale.edu

Locations
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
Investigators
Principal Investigator: Kurt E Roberts, MD Yale School of Medicine
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kurt Roberts, MD / Primary Investigator, Yale School of Medicine
ClinicalTrials.gov Identifier: NCT00806429     History of Changes
Other Study ID Numbers: 0712003306
Study First Received: December 2, 2008
Last Updated: December 8, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014