ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00962338
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : August 22, 2011
Sponsor:
Information provided by (Responsible Party):
Mette Astrup Madsen, Zealand University Hospital

Brief Summary:
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 or disease Intervention/treatment
Inguinal Hernia Convalescence Behavioral: Information

Study Type : Observational
Actual Enrollment : 210 participants
Time Perspective: Prospective
Official Title: Pain and Convalescence After Laparoscopic Groin Hernia Repair
Study Start Date : August 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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:
  • Groin hernia repair
  • TAPP
  • Convalescence




Primary Outcome Measures :
  1. duration of convalescence [ Time Frame: 3 weeks in average ]

Secondary Outcome Measures :
  1. Pain scores on visual analog scale and verbal rating scale [ Time Frame: 6 months ]
    daily first 4 days, after 1 and 6 months

  2. fatigue scores on numeric rating scale (1-10) [ Time Frame: 6 months ]
    daily first 4 days, 1 and 6 months

  3. sexual dysfunction [ Time Frame: 6 months ]
  4. nausea scores on verbal rating scale [ Time Frame: 3 days ]
  5. vomiting [ Time Frame: 3 days ]
  6. wellbeing scores on visual analog scale [ Time Frame: 6 months ]
  7. Hospital anxiety and depression scale (HAD) [ Time Frame: Baseline (before operation) ]
  8. Pain catastrophizing scale (PCS) [ Time Frame: Baseline (before operation) ]
  9. Activity assessment scale (AAS) [ Time Frame: Baseline (before operation) ]
    Functional status



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962338


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mette Astrup Madsen, M.D., Zealand University Hospital
ClinicalTrials.gov Identifier: NCT00962338     History of Changes
Other Study ID Numbers: SJ-125
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: August 22, 2011
Last Verified: August 2011

Keywords provided by Mette Astrup Madsen, Zealand University Hospital:
convalescence
pain
nausea
vomiting
sexual dysfunction

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