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OpenTrials
Completed

NCT Number: NCT00962338

Pain and Convalescence After Laparoscopic Groin Hernia Repair

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.

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Key information

Conditions

Inguinal Hernia Convalescence Disease Attributes Genital Diseases Hernia Hernia, Abdominal Hernia, Inguinal Nausea Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sexual Dysfunction, Physiological Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Vomiting

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Køge

Koege, Region Sjælland, 4600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Information

Behavioral

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 outcomes

  1. duration of convalescence

    Time frame: 3 weeks in average

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Acronym: Lap-Lyske

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 20, 2009
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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