NCT01105039

Brief Summary

Pain after laparoscopic groin hernia repair consist of different pain components (overall pain, shoulder pain, incisional pain and visceral pain). Thus it is important to find out which of these pain components that is most severe, so intervention can be targeted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2009

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

November 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 18, 2011

Status Verified

February 1, 2011

Enrollment Period

9 months

First QC Date

April 13, 2010

Last Update Submit

April 15, 2011

Conditions

Inguinal HerniaFemoral Hernia

Keywords

Pain patternoverall painincisional painshoulder painvisceral pain

Outcome Measures

Primary Outcomes (1)

  • Overall pain during coughing (visual analog scale)

    3 days

Secondary Outcomes (3)

  • shoulder pain during coughing (visual analog scale and verbal rating scale)

    3 days

  • incisional pain during coughing (visual analog scale and verbal rating scale)

    3 days

  • visceral pain during coughing (visual analog scale and verbal rating scale)

    3 days

Study Arms (1)

lap. hernia repair

undergoing laparoscopic groin hernia repair

Eligibility Criteria

Age18 Years - 69 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients are consecutively included in this study. They are all undergoing elective laparoscopic groin hernia repair.

You may qualify if:

  • men
  • years
  • uni- or bilateral hernia
  • ASA I-II
  • Danish speaking

You may not qualify if:

  • bad compliance
  • acute operation
  • daily intake of opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Koge

Køge, Sealand, 4600, Denmark

Location

MeSH Terms

Conditions

Hernia, InguinalHernia, FemoralShoulder PainVisceral Pain

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsNociceptive Pain

Study Officials

  • Mette A Tolver, M.D.

    Koge Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 16, 2010

Study Start

November 1, 2009

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

April 18, 2011

Record last verified: 2011-02

Locations

DK(1)