Pain and Convalescence After Laparoscopic Groin Hernia Repair (Lap-Lyske)

August 19, 2011 updated by: Mette Astrup Madsen, Zealand University Hospital
The investigators want to identify limiting factors for short convalescence after laparoscopic groin hernia repair. Before the operation patients are given intensive structured information about one day´s convalescence. Patients fill out questionnaire before operation about several clinically relevant parameters. This is also done first 3 days after operation and after 1 month and 6 months. The patients are seen for clinical control at 1 and 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Sjaelland
      • Koege, Region Sjaelland, Denmark, 4600
        • University Hospital Køge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The population are from Region Sjaelland and are planned for laparoscopic inguinal or femoral herniorrhaphy. Single university hospital department i Denmark.

Description

Inclusion Criteria:

  • planned laparoscopic inguinal or femoral herniorrhaphy
  • ASA class I-II
  • speak and read danish

Exclusion Criteria:

  • converting to open operation
  • low compliance (dementia, psychiatric disorder)
  • use of morphine or similar drugs daily in the last month
  • complications to the operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lap. inguinal herniorrhaphy
Patients undergoing planned lap. inguinal herniorrhaphy
Behavioral: Information
Information on short convalescence (1 day). Example: Operated today and getting started with normal activities again tomorrow.
Other Names:
  • TAPP
  • Groin hernia repair
  • Convalescence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration of convalescence
Time Frame: 3 weeks in average
3 weeks in average

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores on visual analog scale and verbal rating scale
Time Frame: 6 months
daily first 4 days, after 1 and 6 months
6 months
fatigue scores on numeric rating scale (1-10)
Time Frame: 6 months
daily first 4 days, 1 and 6 months
6 months
sexual dysfunction
Time Frame: 6 months
6 months
nausea scores on verbal rating scale
Time Frame: 3 days
3 days
vomiting
Time Frame: 3 days
3 days
wellbeing scores on visual analog scale
Time Frame: 6 months
6 months
Hospital anxiety and depression scale (HAD)
Time Frame: Baseline (before operation)
Baseline (before operation)
Pain catastrophizing scale (PCS)
Time Frame: Baseline (before operation)
Baseline (before operation)
Activity assessment scale (AAS)
Time Frame: Baseline (before operation)
Functional status
Baseline (before operation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Mette A Tolver, M.D., University Hospital Køge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 19, 2009

First Submitted That Met QC Criteria

August 19, 2009

First Posted (Estimate)

August 20, 2009

Study Record Updates

Last Update Posted (Estimate)

August 22, 2011

Last Update Submitted That Met QC Criteria

August 19, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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