Persistent Pain After Laparoscopic Inguinal Hernia Repair | NCT01085110

Studies
Persistent Pain After Laparoscopic Inguinal Hernia Repair

NCT01085110

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

May 30, 2012Estimated

Enrollment

11Actual

Phase

Not provided

Conditions

Pain, Postoperative
Neuropathic Pain
Postherniotomy Pain

Interventions

Not provided

Countries

Denmark

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

Jan 2010

Primary Completion Date

Apr 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Mar 10, 2010

First Submission Date that Met QC Criteria

Mar 10, 2010

First Posted Date

Mar 11, 2010Estimated

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 29, 2012

Last Update Posted Date

May 30, 2012Estimated

Name	Class
Innovative Medicines Initiative	OTHER

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

Describe and characterizes laparoscopic postherniotomy patients with persistent moderate/severe pain affecting every day activities - including detailed quantitative sensory assessment

Detailed Description

Not provided

Conditions Module

Conditions

Pain, Postoperative
Neuropathic Pain
Postherniotomy Pain

Keywords

Groin hernia
Chronic pain
QST
Quantitative sensory testing
Persistent postoperative pain
Laparoscopic inguinal herniotomy
Postherniotomy Pain after laparoscopic inguinal herniotomy
laparoscopic inguinal hernia repair

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Persistent Pain patients		Patients with persistent postherniotomy pain after laparoscopic operation and pain related impaired daily function

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patients > 18 yrs
No sign of hernia recurrence
Chronic groin pain lasting more than 3 months
Moderate/severe pain related impairment of everyday activities

Exclusion Criteria:

Other causes of persistent pain in groin region (hip, other surgical procedures)
Drug or alcohol abuse
Conflicting neurological disorders

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with persistent pain after laparoscpic inguinal hernia repair

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gitte Linderoth, MD	Section of Surgical Pathophysiology, Rigshospitalet	Principal Investigator
Henrik Kehlet, MD, Proff	Section of Surgical Pathophysiology, Rigshospitalet	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Section of Surgical Pathophysiology, Rigshospitalet, Copenhagen University		Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D009437	Neuralgia
D006552	Hernia, Inguinal
D059350	Chronic Pain

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided