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

Inguinal Hernia Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02315209
• Other study ID #: GR13-108
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 9, 2014
• Last updated: December 9, 2014
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2014
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational [Patient Registry]

Clinical Trial 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.).

Description:

• Rationale

1. In the care of inguinal hernias exists a considerable diversity of methods. Germany is expected to experience a significant shift of service delivery from inpatient to outpatient care within the next few years. As a result of this, the need for quality-controlled procedures in the ambulatory use has emerged.

2. A first register phase for open inguinal hernia was designed in 2010 and is now almost finished. After the evaluation of approximately 6,000 patient records, the process is considered to be extremely successful.

3. As a central result of this first register phase can already be stated that the integration of 3D meshes in a standardized process proved to be extremely effective in open inguinal hernia. In all of the examined relevant parameters, a quality of care well above the status quo could be exhibited.

4. This data quality is unique to the hernia care not only in Germany. In Contrast, the results also achieved considerable international attention. Hence, the working group received the Fruchaud prize for presenting the results of the American Hernia Society 2013. (see Annex, www.americanherniasociety.org)

• Objective

a. Since this approach has proven successful in the first register phase in every respect, it is now to be continued for another two years in order to develop the basis to establish this concept as widespread (outpatient) standard. The central question will be investigated of whether the outstanding results of register phase 1 will also occur in a wide and distributed application to more centers. If this can be proved, the conditions based on worldwide unique scientific data (methodology and follow-up rates, see below) are created to establish the standard surgical procedure with central integration of 3D meshes (UPP UHS) as gold standard against the Lichtenstein method in the outpatient sector.

• Design

1. Prospective multicenter observational study of online-based (daily updated) recording of all relevant pre-, peri-and postoperative data, including patient- as well as physician-specific follow up.

2. Analysis of the most relevant patient-specific endpoints recurrence, pain and quality of life with a 4, 12 and 52 weeks follow-up and the use of psychometrically validated Carolina Comfort Scale (anonymous and tamper-resistant).

3. Significant expansion of the participating centers with a special comparison of the quality of results between newly added centers and centers, that have been proven already.

4. Duration: 01/01/2014 - 12/31/2015 with an additional one-year follow-up to 12/31/2016.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4000
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary and recurrent inguinal Hernia

• Age>18ys

• using 3D devices

Exclusion Criteria:

• Age under 18 ys.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Magdeburg

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	Evaluation with Carolina Comfort Scale	4-12-52 weeks after surgery	No
Secondary	Postoperative Complications	clinical examination	4-12 weeks after surgery	No
Secondary	pain after Surgery	clinical examination, questionnaire, VAS	4-12-52 weeks after surgery	No
Secondary	Recurrence	clinical examination	4-12-52 weeks after surgery	No