The Effect of Sutures Versus Mesh in Umbilical Hernia Repair

Completed

• Conditions: Ventral Hernia Midline

• Registration Number: NCT01635868
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-10
• Study Start: 2012-12
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1313

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrence (clinical or reoperation for recurrence)	3 years	follow-up time will be from 3-5 years

Secondary Outcome Measures

Name	Time	Method
chronic pain	3-5 years after surgery	patient self-registration on VRS. Moderate or severe pain is regarded as chronic pain

Trial Locations

Locations (1)

Hvidovre Hospital University of Copenhagen; 🇩🇰 Hvidovre, Denmark