The Effect of Sutures Versus Mesh in Umbilical Hernia Repair (ABSNOME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mette Willaume Christoffersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01635868
First received: July 4, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition
Ventral Hernia Midline

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • recurrence (clinical or reoperation for recurrence) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    follow-up time will be from 3-5 years


Secondary Outcome Measures:
  • chronic pain [ Time Frame: 3-5 years after surgery ] [ Designated as safety issue: No ]
    patient self-registration on VRS. Moderate or severe pain is regarded as chronic pain


Other Outcome Measures:
  • risk factors for recurrence and chronic pain [ Time Frame: 3-5 yrs ] [ Designated as safety issue: No ]
    We identify risk factor for chronic pain and recurrence


Enrollment: 1313
Study Start Date: December 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
umbilical hernia repair
patients having umbilical or epigastric hernia repair from 2008-2010 in Zealand

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635868

Locations
Denmark
Hvidovre Hospital University of Copenhagen
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Study Director: Thue Bisgaard, DMSc University Hospital of Copenhagen Hvidovre
  More Information

No publications provided

Responsible Party: Mette Willaume Christoffersen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01635868     History of Changes
Other Study ID Numbers: ABSNOME
Study First Received: July 4, 2012
Last Updated: February 19, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 22, 2014