Chronic Complaints After Small Umbilical Hernia Repair | NCT01741740

Studies
Chronic Complaints After Small Umbilical Hernia Repair

NCT01741740

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Dec 24, 2012Estimated

Enrollment

295Actual

Phase

Not provided

Conditions

Chronic Pain
Ventral Hernia

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000

Primary Completion Date

Jan 2005Actual

Completion Date

Jan 2009Actual

First Submitted Date

Dec 3, 2012

First Submission Date that Met QC Criteria

Dec 4, 2012

First Posted Date

Dec 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2012

Last Update Posted Date

Dec 24, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

295Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
retrospective surgical patients		consecutive elective umbilical hernia repair patients during two years from two hospitals,- retrospective id with prospective follow up

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thue Bisgaard, DMSc	Hvidovre and Glostrup University Hospitals	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain
D006555	Hernia, Ventral
D010146	Pain
D006547	Hernia
D000092122	Bronchiolitis Obliterans Syndrome

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D046449	Hernia, Abdominal

Browse Leaves

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Browse Branches

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