Chronic Complaints After Small Umbilical Hernia Repair

High Incidence of Chronic Complaints and Recurrence 5 Years After Simple Sutured Umbilical Hernia Repair

There are only little data on the risk of chronic complaints (pain and discomfort) following open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly recurrence. The setup was a retrospective two-centre study including patients ≥18 years undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. The survey included questions on suspicion of recurrence, reoperation for recurrence (if yes patients were examined by a consultant in patients home), pain, discomfort, work, and leisure activities. We analysed 295 consecutive patients through a non-validated structured questionnaire.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Ventral Hernia

• Study Type: Observational
• Enrollment (Actual): 295

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repair during a five years period

Description

Inclusion Criteria:

• primary elective open non-mesh sutured umbilical or epigastric hernia repair

Exclusion Criteria:

• mesh repair, acute repair, repair secondary to other operation, recurrent hernia repair, combined hernia repair, laparoscopic hernie repair, trocar hernia repair, incompensated liver cirrhosis, age < 18 years, pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
retrospective surgical patients; consecutive elective umbilical hernia repair patients during two years from two hospitals,- retrospective id with prospective follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain at rest at the hernia repair site	a verbal rating scale for pain is used (none, little, moderate or severe	chronic complaints 5 years after hernia repair

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
discomfort at rest at the hernia site	a verbal rating scale for pain is used (none, little, moderate or severea	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence	reoperation for recurrence combined with clinical examination for non reoperated recurrences	five years

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Principal Investigator: Thue Bisgaard, DMSc, Hvidovre and Glostrup University Hospitals

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): January 1, 2005
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): December 24, 2012
• Last Update Submitted That Met QC Criteria: December 21, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: pain, hernia, chronic, discomfort, retrospective
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Chronic Pain; Hernia, Ventral; Hernia, Umbilical
• Other Study ID Numbers: SMALLUMBI123