NCT01085110

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

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

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

3 months

First QC Date

March 10, 2010

Last Update Submit

May 29, 2012

Conditions

Pain, PostoperativeNeuropathic PainPostherniotomy Pain

Keywords

Groin herniaChronic painQSTQuantitative sensory testingPersistent postoperative painLaparoscopic inguinal herniotomyPostherniotomy Pain after laparoscopic inguinal herniotomylaparoscopic inguinal hernia repair

Study Arms (1)

Persistent Pain patients

Patients with persistent postherniotomy pain after laparoscopic operation and pain related impaired daily function

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with persistent pain after laparoscpic inguinal hernia repair

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Surgical Pathophysiology, Rigshospitalet, Copenhagen University

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Pain, PostoperativeNeuralgiaHernia, InguinalChronic Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesHernia, AbdominalHerniaPathological Conditions, Anatomical

Study Officials

  • Gitte Linderoth, MD

    Section of Surgical Pathophysiology, Rigshospitalet

    PRINCIPAL INVESTIGATOR

  • Henrik Kehlet, MD, Proff

    Section of Surgical Pathophysiology, Rigshospitalet

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 11, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

DK(1)