Chronic Complaints After Small 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.

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Key information

Conditions

Chronic Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Hernia Hernia, Abdominal Hernia, Ventral Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Ventral Hernia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

pain at rest at the hernia repair site

Time frame: chronic complaints 5 years after hernia repair

a verbal rating scale for pain is used (none, little, moderate or severe

Secondary outcomes

discomfort at rest at the hernia site

Time frame: 5 years

a verbal rating scale for pain is used (none, little, moderate or severea

Other outcomes

recurrence

Time frame: five years

reoperation for recurrence combined with clinical examination for non reoperated recurrences

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2000
Primary completion: 2005
Study completion: 2009
First posted: Dec 5, 2012
Registry last updated: Dec 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed