A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair

NCT02240550 | Completed

• 1 other identifier: P0133
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs. Lichtenstein inguinal hernia repair.

Conditions

Inguinal Hernia

Keywords

Open Inguinal Hernia

Outcome Measures

Primary Outcomes (2)

• Evaluate the immediate and short-term amount of pain.

  We will evaluate the immediate and short-term amount of pain using the VAS and Carolinas Comfort Scale (CCS) assessments held at regular intervals.

  1 month

• Compare the time required for return to normal activities (work).

  We will capture the time required to return to normal activities as indicated by the patient.

  1 month

Secondary Outcomes (1)

• Identify any short-term related complication/adverse events associated with the procedures.

  1 month

Study Arms (2)

ProFlor Hernia Repair System

ACTIVE COMPARATOR

A 3-D hernia mesh

Device: ProFlor Hernia Repair System

Lichtenstein Hernia Repair

ACTIVE COMPARATOR

Using flat polypropylene mesh

Device: Lichtenstein hernia repair

Interventions

ProFlor Hernia Repair System DEVICE

The 3-D hernia mesh will be used in the repair of your inguinal hernia.

Also known as: 3D mesh

ProFlor Hernia Repair System

Lichtenstein hernia repair DEVICE

The standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia.

Also known as: Polypropylene

Lichtenstein Hernia Repair

Eligibility Criteria

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

You may qualify if:

• Scheduled to undergo routine inguinal hernia repair
• Male and Female patients between 18 and 65 years old
• Competent to give consent
• Clinically relevant inguinal hernia (classification: EHS P L/M 1/2/3)
• Defect size at operation is between 5mm and 35mm
• Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
• Primary hernia at the operative site

You may not qualify if:

• Signs of obvious local or systemic infection
• Any previous surgery on the hernia operative site
• Hernia is not in the inguinal area
• Hernia is not identified as indirect or direct
• Femoral hernias
• Known collagen disorder
• Presenting with unstable angina or NYHA class of IV
• Known Pregnancy or Nursing women
• Active drug user
• Recurrence of a repair by any method
• Patients with giant inguinoscrotal hernia or abdominal wall defect \>35 mm in diameter - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3
• Immunosuppression, prednisone\>15 mg/day, active chemotherapy
• End stage renal disease
• Abdominal ascites
• Skin infection in area of surgical field

Sponsors & Collaborators

• Insightra Medical, Inc.: lead

Study Sites (1)

Healing Hands Clinic

Pune, India

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

Study Officials

• John Murphy, MD

  Healing Hands Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 15, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

IN (1)