NCT00806429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 17, 2017

Status Verified

January 1, 2012

Enrollment Period

3.3 years

First QC Date

December 2, 2008

Last Update Submit

October 13, 2017

Conditions

Appendicitis

Keywords

appendicitissurgerylaparoscopynatural orifice transluminal surgery

Outcome Measures

Primary Outcomes (1)

  • feasibility of transvaginal appendectomy

    1 year

Secondary Outcomes (2)

  • pain

    1 year

  • quality of life

    1 year

Study Arms (2)

1

EXPERIMENTAL

transvaginal appendectomy

Procedure: transvaginal appendectomy

2

NO INTERVENTION

Interventions

transvaginal appendectomyPROCEDURE

patient undergoes transvaginal appendectomy

1

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ultrasound or CT-based diagnosis of acute or chronic appendicitis
  • ASA classification 1 or 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

    PMID: 22167005DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Kurt E Roberts, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 10, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 17, 2017

Record last verified: 2012-01

Locations

US(1)