The Effect of Sutures Versus Mesh in Umbilical Hernia Repair (ABSNOME)
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|ClinicalTrials.gov Identifier: NCT01635868|
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : February 20, 2014
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.
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.
|Condition or disease|
|Ventral Hernia Midline|
|Study Type :||Observational|
|Actual Enrollment :||1313 participants|
|Official Title:||Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.|
|Study Start Date :||December 2012|
|Primary Completion Date :||October 2013|
|Study Completion Date :||October 2013|
umbilical hernia repair
patients having umbilical or epigastric hernia repair from 2008-2010 in Zealand
- recurrence (clinical or reoperation for recurrence) [ Time Frame: 3 years ]follow-up time will be from 3-5 years
- chronic pain [ Time Frame: 3-5 years after surgery ]patient self-registration on VRS. Moderate or severe pain is regarded as chronic pain
- risk factors for recurrence and chronic pain [ Time Frame: 3-5 yrs ]We identify risk factor for chronic pain and recurrence
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635868
|Hvidovre Hospital University of Copenhagen|
|Hvidovre, Denmark, 2650|
|Study Director:||Thue Bisgaard, DMSc||University Hospital of Copenhagen Hvidovre|