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Chronic Complaints After Small Umbilical Hernia Repair

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ClinicalTrials.gov Identifier: NCT01741740
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 24, 2012
Sponsor:
Information provided by (Responsible Party):
Thue Bisgaard, Hvidovre University Hospital

Brief Summary:
There are only little data on the risk of chronic complaints (pain and discomfort) following open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly recurrence. The setup was a retrospective two-centre study including patients ≥18 years undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. The survey included questions on suspicion of recurrence, reoperation for recurrence (if yes patients were examined by a consultant in patients home), pain, discomfort, work, and leisure activities. We analysed 295 consecutive patients through a non-validated structured questionnaire.

Condition or disease
Chronic Pain Ventral Hernia

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Study Type : Observational
Actual Enrollment : 295 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: High Incidence of Chronic Complaints and Recurrence 5 Years After Simple Sutured Umbilical Hernia Repair
Study Start Date : January 2000
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort
retrospective surgical patients
consecutive elective umbilical hernia repair patients during two years from two hospitals,- retrospective id with prospective follow up



Primary Outcome Measures :
  1. pain at rest at the hernia repair site [ Time Frame: chronic complaints 5 years after hernia repair ]
    a verbal rating scale for pain is used (none, little, moderate or severe


Secondary Outcome Measures :
  1. discomfort at rest at the hernia site [ Time Frame: 5 years ]
    a verbal rating scale for pain is used (none, little, moderate or severea


Other Outcome Measures:
  1. recurrence [ Time Frame: five years ]
    reoperation for recurrence combined with clinical examination for non reoperated recurrences



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repair during a five years period
Criteria

Inclusion Criteria:

  • primary elective open non-mesh sutured umbilical or epigastric hernia repair

Exclusion Criteria:

  • mesh repair, acute repair, repair secondary to other operation, recurrent hernia repair, combined hernia repair, laparoscopic hernie repair, trocar hernia repair, incompensated liver cirrhosis, age < 18 years, pregnancy

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): NCT01741740


Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Thue Bisgaard, DMSc Hvidovre and Glostrup University Hospitals
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Responsible Party: Thue Bisgaard, MD, DMSc, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01741740    
Other Study ID Numbers: SMALLUMBI123
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: December 24, 2012
Last Verified: December 2012
Keywords provided by Thue Bisgaard, Hvidovre University Hospital:
pain, hernia, chronic, discomfort, retrospective
Additional relevant MeSH terms:
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Hernia, Umbilical
Chronic Pain
Hernia
Hernia, Ventral
Pain
Neurologic Manifestations
Pathological Conditions, Anatomical
Hernia, Abdominal
Infant, Newborn, Diseases