The Effect of Sutures Versus Mesh in Umbilical Hernia Repair
CompletedNCT01635868
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Background Mesh repair reduces the risk of reoperation for recurrence in patients with small umbilical and epigastric hernias compared with sutured repair. However, reoperation for recurrence underestimates total recurrence (reoperation or clinical) and mesh reinforcement may induce chronic pain. This study investigated the cumulated risk of recurrence after open mesh and sutured repair in small (≤2 cm) umbilical and epigastric hernias. Possible risk factors were evaluated for chronic pain and recurrence. Methods A cohort study with questionnaire-follow-up was conducted. Patients with primary, elective, open mesh or sutured repair for a small umbilical or epigastric hernia (≤2 cm) were included. Follow-up was performed by a validated questionnaire regarding suspicion of recurrence and chronic pain (moderate or severe). Suspected recurrence qualified for clinical examination. Recurrence was defined as reoperation for recurrence or clinical recurrence. Risk factors for recurrence and chronic pain were investigated by multivariate analyses. Results 1 313 patients completed the questionnaire and/or clinical follow-up (83 % response rate) and follow-up time was median 40 months (range 0-66 months). The total cumulated recurrence rate 55 months after primary repair was 10 % for mesh repair and 21 % for sutured repair (P=0.001). The incidence of chronic pain was 6 % after mesh repair and 5 % after sutured repair (P = 0.711). Recurrence was the only independent risk factor for chronic pain (P\<0.001). Conclusion Mesh repair halved the long-term risk of recurrence after repair for small umbilical and epigastric hernias without increased risk of chronic pain.
Study details
- Official title
- Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.
- Conditions
- Ventral Hernia Midline
- Sponsor
- Hvidovre University Hospital
- Start date
- 2012-12
- Primary completion
- 2013-10
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * elective open mesh or sutured repair of small umbilical or epigastric hernia repairs Exclusion Criteria: * acute operation * operation outside region of Zealand * laparoscopic repair
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01635868