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Transvaginal Appendectomy

Primary Purpose

Appendicitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

transvaginal appendectomy

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring appendicitis, surgery, laparoscopy, natural orifice transluminal surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Yale-New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

transvaginal appendectomy

Outcomes

Primary Outcome Measures

feasibility of transvaginal appendectomy

Secondary Outcome Measures

pain

quality of life

Full Information

NCT ID

NCT00806429

First Posted

December 2, 2008

Last Updated

October 13, 2017

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT00806429

Brief Title

Transvaginal Appendectomy

Official Title

Transvaginal Appendectomy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Appendicitis

Keywords

appendicitis, surgery, laparoscopy, natural orifice transluminal surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

transvaginal appendectomy

Arm Title

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

transvaginal appendectomy

Intervention Description

patient undergoes transvaginal appendectomy

Primary Outcome Measure Information:

Title

feasibility of transvaginal appendectomy

Time Frame

1 year

Secondary Outcome Measure Information:

Title

pain

Time Frame

1 year

Title

quality of life

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kurt E Roberts, MD

Organizational Affiliation

Yale School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale-New Haven Hospital

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22167005

Citation

Roberts KE, Solomon D, Mirensky T, Silasi DA, Duffy AJ, Rutherford T, Longo WE, Bell RL. Pure transvaginal appendectomy versus traditional laparoscopic appendectomy for acute appendicitis: a prospective cohort study. Ann Surg. 2012 Feb;255(2):266-9. doi: 10.1097/SLA.0b013e31823b2748.

Results Reference

derived

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Transvaginal Appendectomy

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