Clinical trial NCT01635868: The Effect of Sutures Versus Mesh in Umbilical Hernia Repair
Official title: Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia Midline
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 1313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: recurrence (clinical or reoperation for recurrence)
timeFrame: 3 years
Secondary outcomes:
measure: chronic pain
timeFrame: 3-5 years after surgery
Other outcomes:
measure: risk factors for recurrence and chronic pain
timeFrame: 3-5 yrs
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital University of Copenhagen
Study officials:
affiliation: University Hospital of Copenhagen Hvidovre
name: Thue Bisgaard, DMSc
role: STUDY_DIRECTOR
References: