NCT01635868|Completed
The Effect of Sutures Versus Mesh in Umbilical Hernia Repair
ABSNOME
Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.
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ABSNOME
Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.
Sponsor study identifier
observational
1,313
1 country
1
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Study Completion
October 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 4, 2012
Actual (reported)July 10, 2012
Actual (reported)December 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 2013
Actual (reported)October 2013
Actual (reported)recurrence (clinical or reoperation for recurrence)
follow-up time will be from 3-5 years
3 years
chronic pain
3-5 years after surgery
risk factors for recurrence and chronic pain
3-5 yrs
patients having umbilical or epigastric hernia repair from 2008-2010 in Zealand
all patient having mesh or sutured repair of small (\> 2 cm) umbilical or epigastric hernias in the region of Zealand from 1th of January 2008 to 31th of December 2010.
Hvidovre Hospital University of Copenhagen
Hvidovre, 2650, Denmark
Thue Bisgaard, DMSc
University Hospital of Copenhagen Hvidovre
1,313 participants (actual enrollment reported by the registry).
First Submitted
July 4, 2012
First Posted
July 10, 2012
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2013
Actual (reported)Study Completion
October 2013
Actual (reported)Last Updated
February 20, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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