Chronic Complaints After Small Umbilical Hernia Repair

Chronic Pain Clinical Trial

Official title:

High Incidence of Chronic Complaints and Recurrence 5 Years After Simple Sutured Umbilical Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741740
• Other study ID #: SMALLUMBI123
• 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

Related Conditions & MeSH terms

• Chronic Pain
• Hernia
• Hernia, Umbilical
• Hernia, Ventral
• Ventral Hernia

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