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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mette Astrup Madsen, University Hospital Koge
ClinicalTrials.gov Identifier:
NCT00962338
First received: August 19, 2009
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Inguinal Hernia
Convalescence
Behavioral: Information

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pain and Convalescence After Laparoscopic Groin Hernia Repair

Resource links provided by NLM:


Further study details as provided by University Hospital Koge:

Primary Outcome Measures:
  • duration of convalescence [ Time Frame: 3 weeks in average ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain scores on visual analog scale and verbal rating scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    daily first 4 days, after 1 and 6 months

  • fatigue scores on numeric rating scale (1-10) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    daily first 4 days, 1 and 6 months

  • sexual dysfunction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • nausea scores on verbal rating scale [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • vomiting [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • wellbeing scores on visual analog scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hospital anxiety and depression scale (HAD) [ Time Frame: Baseline (before operation) ] [ Designated as safety issue: No ]
  • Pain catastrophizing scale (PCS) [ Time Frame: Baseline (before operation) ] [ Designated as safety issue: No ]
  • Activity assessment scale (AAS) [ Time Frame: Baseline (before operation) ] [ Designated as safety issue: No ]
    Functional status


Enrollment: 210
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • Groin hernia repair
  • TAPP
  • Convalescence

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962338

Locations
Denmark
University Hospital Køge
Koege, Region Sjaelland, Denmark, 4600
Sponsors and Collaborators
University Hospital Koge
Investigators
Principal Investigator: Mette A Tolver, M.D. University Hospital Køge
  More Information

No publications provided by University Hospital Koge

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mette Astrup Madsen, M.D., University Hospital Koge
ClinicalTrials.gov Identifier: NCT00962338     History of Changes
Other Study ID Numbers: SJ-125
Study First Received: August 19, 2009
Last Updated: August 19, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital Koge:
convalescence
pain
nausea
vomiting
sexual dysfunction

Additional relevant MeSH terms:
Convalescence
Hernia
Hernia, Inguinal
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 16, 2014