Ventral Hernia Midline Clinical Trial
— ABSNOMEOfficial title:
Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.
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.
| Status | Completed |
| Enrollment | 1313 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Hvidovre Hospital University of Copenhagen | Hvidovre |
| Lead Sponsor | Collaborator |
|---|---|
| Hvidovre University Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | risk factors for recurrence and chronic pain | We identify risk factor for chronic pain and recurrence | 3-5 yrs | No |
| Primary | recurrence (clinical or reoperation for recurrence) | follow-up time will be from 3-5 years | 3 years | No |
| Secondary | chronic pain | patient self-registration on VRS. Moderate or severe pain is regarded as chronic pain | 3-5 years after surgery | No |