High Incidence of Chronic Complaints and Recurrence 5 Years After Simple Sutured Umbilical Hernia Repair
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 295
- Primary Endpoint
- pain at rest at the hernia repair site
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- discomfort at rest at the hernia site(5 years)
Investigators
Thue Bisgaard
MD, DMSc
Hvidovre University Hospital