Transvaginal Appendectomy | NCT00806429

Studies
Transvaginal Appendectomy

NCT00806429

Sponsor

Yale University

Status

Completed

Last Update Posted

Oct 17, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Appendicitis

Interventions

transvaginal appendectomy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 2, 2008

First Submission Date that Met QC Criteria

Dec 8, 2008

First Posted Date

Dec 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2017

Last Update Posted Date

Oct 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	transvaginal appendectomy	Procedure: transvaginal appendectomy
2	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transvaginal appendectomy	Procedure	patient undergoes transvaginal appendectomy	1

Measure	Description	Time Frame
feasibility of transvaginal appendectomy		1 year

Measure	Description	Time Frame
pain		1 year
quality of life		1 year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kurt E Roberts, MD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale-New Haven Hospital		New Haven	Connecticut	06510	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22167005	Derived	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.

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases