The Effect of Sutures Versus Mesh in Umbilical Hernia Repair

NCT ID: NCT01635868

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1313 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-10-31

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.

Conditions

Ventral Hernia Midline

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

umbilical hernia repair

patients having umbilical or epigastric hernia repair from 2008-2010 in Zealand

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mette Willaume Christoffersen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thue Bisgaard, DMSc

Role: STUDY_DIRECTOR

University Hospital of Copenhagen Hvidovre

Locations

Hvidovre Hospital University of Copenhagen

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

ABSNOME

Identifier Type: -

Identifier Source: org_study_id