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

NCT02315209 | Unknown DMC

• 1 other identifier: GR13-108
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Inguinal Hernia, Quality of Life, Mesh

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  Evaluation with Carolina Comfort Scale

  4-12-52 weeks after surgery

Secondary Outcomes (3)

• Postoperative Complications

  4-12 weeks after surgery

• pain after Surgery

  4-12-52 weeks after surgery

• Recurrence

  4-12-52 weeks after surgery

Interventions

UHS, UPP, Comfort Plug DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive Patients with inguinal Hernia, Age \>18 ys., Mesh Augmentation with Ultra Pro Hernia System, Ultra pro Plug or Ultra pro comfort Plug

You may qualify if:

• Primary and recurrent inguinal Hernia
• Age\>18ys
• using 3D devices

You may not qualify if:

• \- Age under 18 ys.

Sponsors & Collaborators

• University of Magdeburg: lead

Related Publications (1)

• Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1.

  PMID: 18387468 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Koch, MD, FACS

  Institute for Quality Assurance in Operative Medicine

  PRINCIPAL INVESTIGATOR

• Ralph Lorenz, MD

  Institute for Quality Assurance in Operative Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Member of the Scientific Board

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 11, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 11, 2014

Record last verified: 2014-12