The Effect of Sutures Versus Mesh in Umbilical Hernia Repair

NCT01635868 | Completed

• 1 other identifier: ABSNOME
• Study Type: observational
• Target: 1,313
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• recurrence (clinical or reoperation for recurrence)

  follow-up time will be from 3-5 years

  3 years

Secondary Outcomes (1)

• chronic pain

  3-5 years after surgery

Other Outcomes (1)

• risk factors for recurrence and chronic pain

  3-5 yrs

Study Arms (1)

umbilical hernia repair

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• elective open mesh or sutured repair of small umbilical or epigastric hernia repairs

You may not qualify if:

• acute operation
• operation outside region of Zealand
• laparoscopic repair

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre Hospital University of Copenhagen

Hvidovre, 2650, Denmark

Location

Study Officials

• Thue Bisgaard, DMSc

  University Hospital of Copenhagen Hvidovre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: July 10, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

DK (1)