Single Incision Laparoscopic Appendectomy in the Communit... | NCT00925145

Studies
Single Incision Laparoscopic Appendectomy in the Community Utilizing Conventional Instruments

NCT00925145

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Jun 3, 2011Estimated

Enrollment

32Estimated

Phase

Not provided

Conditions

Appendicitis

Interventions

Single Incision Laparoscopic Appendectomy

Countries

Canada

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

Jun 2011

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

Jul 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jun 18, 2009

First Submission Date that Met QC Criteria

Jun 18, 2009

First Posted Date

Jun 19, 2009Estimated

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

Jun 1, 2011

Last Update Posted Date

Jun 3, 2011Estimated

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

There is a move to "scarless surgery" and this achieved by doing laparoscopic abdominal surgery though a single small umbilical incision. A technique for laparoscopic appendectomy done through a single incision utilizing conventional instruments has been developed. The operative risk of the single incision approach is no different that the standard three incision laparoscopic appendectomy. The goal is to study the operative time, length of hospital stay, and complications from this operation.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Label	Type	Description	Intervention Names
1			Procedure: Single Incision Laparoscopic Appendectomy

Name	Type	Description	Arm Group Labels	Other Names
Single Incision Laparoscopic Appendectomy	Procedure		1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients undergoing appendectomy for acute appendicitis

Exclusion Criteria:

pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients presenting to a community hospital (RGH) with a working diagnosis of acute appendicitis when the investigator (myself) and co-investigator (Dr. Bloom) are on call for general surgery emergencies.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nam Nguyen, MD	University of British Columbia	Principal Investigator
Scott Bloom	University of British Columbia	Study Director
Connie Chiu	University of British Columbia	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Richmond Hospital		Richmond	British Columbia		Canada

Condition Browse Module

MeSH Terms

ID	Term
D001064	Appendicitis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided