Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 4:36 AM
Study NCT ID:
NCT01635868
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2012-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sutures Versus Mesh in Umbilical Hernia Repair
Sponsor:
Hvidovre University Hospital
Organization:
Study Overview
Official Title:
Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABSNOME
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: