Chronic Complaints After Small Umbilical Hernia Repair

NCT ID: NCT01741740

Last Updated: 2012-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

295 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain Ventral Hernia

Keywords

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pain, hernia, chronic, discomfort, retrospective

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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retrospective surgical patients

consecutive elective umbilical hernia repair patients during two years from two hospitals,- retrospective id with prospective follow up

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thue Bisgaard

MD, DMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thue Bisgaard, DMSc

Role: PRINCIPAL_INVESTIGATOR

Hvidovre and Glostrup University Hospitals

Other Identifiers

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SMALLUMBI123

Identifier Type: -

Identifier Source: org_study_id