The Effect of Sutures Versus Mesh in Umbilical Hernia Repair

Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01635868

Acronym

ABSNOME

Enrollment

1313

Registered

2012-07-10

Start date

2012-12-31

Completion date

2013-10-31

Last updated

2014-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventral Hernia Midline

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
recurrence (clinical or reoperation for recurrence)	3 years	follow-up time will be from 3-5 years

Secondary

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

Other

Measure	Time frame	Description
risk factors for recurrence and chronic pain	3-5 yrs	We identify risk factor for chronic pain and recurrence

Countries

Denmark

Outcome results