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Completed

NCT Number: NCT02748629

ProGrip Mesh Repair vs Lichtenstein Operation

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Health Center in Kartuzy

Kartuzy, 83-300, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with primary inguinal hernia
  • Signed consent

Exclusion criteria

  • Recurrent hernia
  • Emergency procedure
  • Patient not willing to participate

Treatment and study plan

Covidien Parietex ProGrip Self-Fixating Mesh

Device

Lightweight Polypropylene Mesh (<38g/m2 after absorption)

Device

Serag Wiessner SERAMESH® PA 15x10 cm

Primary outcomes

  1. Incidence of post-operative pain and its intensity using VAS Scale

    Time frame: 12 Months

    Assessment will be made using Visual Analogue Scale (VAS).

Secondary outcomes

  1. Rate of foreign body sensation - Subjective feeling of discomfort in the groin

    Time frame: 12 Months

    Foreign body sensation is a patients' subjective feeling of discomfort in the groin. Assesment will be made by phone questionnaire.

  2. Hernia recurrence rate

    Time frame: 12 Months

    Recurrence rate is number of hernia recurrences after surgery (can only be diagnosed by surgeon via clinical examination)

  3. Post-operative complications

    Time frame: 12 Months

    Short and Longterm complications: surgical site injury, hematoma, seroma, testicle ischemia, chronic pain)

  4. Duration of surgery

    Time frame: Day of surgery

  5. Incidence of Treatment-Emergent Adverse Events [Safety]

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Regional Health Center in Kartuzy, Poland

Other

Collaborators

  • Medical University of Gdansk

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 22, 2016
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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