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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01741740
Other study ID # SMALLUMBI123
Secondary ID
Status Completed
Phase N/A
First received December 3, 2012
Last updated December 21, 2012
Start date January 2000
Est. completion date January 2009

Study information

Verified date December 2012
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 295
Est. completion date January 2009
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Outcome

Type Measure Description Time frame Safety issue
Other recurrence reoperation for recurrence combined with clinical examination for non reoperated recurrences five years No
Primary pain at rest at the hernia repair site a verbal rating scale for pain is used (none, little, moderate or severe chronic complaints 5 years after hernia repair No
Secondary discomfort at rest at the hernia site a verbal rating scale for pain is used (none, little, moderate or severea 5 years No
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