ProGrip Mesh Repair vs Lichtenstein Operation

Inguinal Hernia Clinical Trial

Official title:

Randomized Controlled Single-Center Trial: Self-Gripping ProGrip Mesh Repair vs Lichtenstein Operation of Inguinal Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748629
• Other study ID #: NKBNN/258/2015
• Status: Completed
• Phase: N/A
• First received: April 12, 2016
• Last updated: October 4, 2016
• Start date: March 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Regional Health Center in Kartuzy, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Independent Bioethics Commission for Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein Operation with lightweight polypropylene mesh.

Description:

Single-center patient-blinded randomized clinical trial comparing self-gripping mesh (Parietex ProGrip) and standard Lichtenstein method using lightweight polypropylene mesh. Patients will be randomly allocated to the Lichtenstein Operation (L) and ProGrip Repair (R) group. Patients will be followed for one year. The primary outcome measure are: postoperative pain using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS). Assessments will be made before the surgery, in the day of discharge, 1, 6 and 12 months postoperatively.

Secondary endpoints: recurrence rate, post-operative complications (short and long-term), foreign body sensation, incidence of surgical-site injury, costs, hospital stay, surgery duration, safety and patients satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with primary inguinal hernia

• Signed consent

Exclusion Criteria:

• Recurrent hernia

• Emergency procedure

• Patient not willing to participate

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Device:
• Covidien Parietex ProGrip Self-Fixating Mesh

• Lightweight Polypropylene Mesh (<38g/m2 after absorption)
Serag Wiessner SERAMESH® PA 15x10 cm

Locations

Country	Name	City	State
Poland	Regional Health Center in Kartuzy	Kartuzy

Sponsors (2)

Lead Sponsor	Collaborator
Regional Health Center in Kartuzy, Poland	Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-operative pain and its intensity using VAS Scale	Assessment will be made using Visual Analogue Scale (VAS).	12 Months	No
Secondary	Rate of foreign body sensation - Subjective feeling of discomfort in the groin	Foreign body sensation is a patients' subjective feeling of discomfort in the groin. Assesment will be made by phone questionnaire.	12 Months	No
Secondary	Hernia recurrence rate	Recurrence rate is number of hernia recurrences after surgery (can only be diagnosed by surgeon via clinical examination)	12 Months	Yes
Secondary	Post-operative complications	Short and Longterm complications: surgical site injury, hematoma, seroma, testicle ischemia, chronic pain)	12 Months	Yes
Secondary	Duration of surgery		Day of surgery	No
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety]		12 Months	Yes