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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Hernia
Hernia, Inguinal
Convalescence
Pathological Conditions, Anatomical
Hernia, Abdominal
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014