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Multicentric Evaluation of UPP, UHS and Ultra Pro Comfort Plug for Inguinal Hernia Surgery Including Quality of Life Evaluation

NCT02315209 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2014-12-11

No results posted yet for this study

Summary

Outpatient services in Germany are less controlled by external quality assurance programs. Comprehensive outcome data for benchmarking or health-care decision-making are missing e.g. for day case surgery. A quality-of-life instrument specific to hernia repair with mesh has been recently proposed (Carolinas Comfort Scale, CCS) .This study evaluates the integration of CSS as part of a multicentre quality assurance scheme for day-case (outpatient) surgery.b.The Study Group on "Quality assurance in ambulatory hernia surgery" has developed and standardized Operation technique for 3D Implants. As a consequence, any deviation must be documented by the standard. The extension to other centers according to a standardized protocol took place (shadowing to learn the operational standards, training in documentation, Minimum quantity 30 interventions per year, etc.).

Conditions

  • Inguinal Hernia

Interventions

DEVICE

UHS, UPP, Comfort Plug

only Repairs with 3D Devices (UPP,UHS,Comfort Plug)

Sponsors & Collaborators

  • University of Magdeburg

    lead OTHER

Principal Investigators

  • Andreas Koch, MD, FACS · Institute for Quality Assurance in Operative Medicine

  • Ralph Lorenz, MD · Institute for Quality Assurance in Operative Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-12-31
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02315209 on ClinicalTrials.gov