Surgery Versus Manual Rupture for Dorsal Carpal Ganglion | NCT01017900

Studies
Surgery Versus Manual Rupture for Dorsal Carpal Ganglion

NCT01017900

Sponsor

Prince of Songkla University

Status

Completed

Last Update Posted

May 15, 2012Estimated

Enrollment

100Estimated

Phase

Phase 3

Conditions

Dorsal Carpal Ganglion

Interventions

local excision

Countries

Thailand

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

May 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

Jun 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Nov 17, 2009

First Submission Date that Met QC Criteria

Nov 20, 2009

First Posted Date

Nov 23, 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

May 12, 2012

Last Update Posted Date

May 15, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Boonsin Tangtrakulwanich, Department of Orthopaedic surgery, Prince of Songkla UniversityPrincipal Investigator

Lead Sponsor

Prince of Songkla UniversityOTHER

Collaborators

Not provided

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

This study objectives are to compare the efficacy and safety between surgical excision and manual rupture for dorsal carpal ganglion.The participants with dorsal carpal ganglion will be randomized into 2 groups:surgical excision or manual rupture.The patients will be follow-up for at least 1 yr.Telephone interview will be used for outcome assessment.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
local excision	Procedure	surgical excision by orthopaedic surgeon under local anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recurrence rate		1,2 and 3 years

Secondary Outcomes

Measure	Description	Time Frame
time to recurrence		1,2 and 3 years
DASH score		1,2 and 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with dorsal carpal ganglion

Exclusion Criteria:

underlying rheumatic condition
bleeding tendency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boonsin Tangtrakulwanich, MD.,Ph.D.	Department of Orthopaedic Surgery,Faculty of Medicine, Prince of Songkla University, Hat Yai,Songkhla, Thailand 90110	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Songklanakarind hospital		Hat Yai	Changwat Songkhla	90110	Thailand

Intervention Browse Module

MeSH Terms

ID	Term
D015412	Mastectomy, Segmental

Ancestor Terms

ID	Term
D008408	Mastectomy
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided