Trial Outcomes & Findings for Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair (NCT NCT01070693)

NCT ID: NCT01070693

Last Updated: 2014-01-16

Results Overview

Any pain at five years

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2014-01-16

Participant Flow

Included were 300 adult patients (282 men, 18 women) referred for elective repair having unilateral or bilateral inguinal hernias. Study period: September 2001 - January 2004, outpatient unit of Jorvi Hospital (Helsinki University Central Hospital, Espoo, Finland).

Participant milestones

Measure	Prolene Hernia System Device Inguinal hernia repair either with a bilayer mesh (PHS)	Lichtenstein Inguinal hernia repair with the Lichtenstein technique
Overall Study STARTED	150	149
Overall Study COMPLETED	122	110
Overall Study NOT COMPLETED	28	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair

Baseline characteristics by cohort

Measure	Prolene Hernia System Device n=150 Participants Inguinal hernia repair either with a bilayer mesh (PHS)	Lichtenstein n=149 Participants Inguinal hernia repair with the Lichtenstein technique	Total n=299 Participants Total of all reporting groups
Age, Continuous	46 years n=5 Participants	47 years n=7 Participants	46 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	140 Participants n=5 Participants	141 Participants n=7 Participants	281 Participants n=5 Participants
Region of Enrollment Finland	150 participants n=5 Participants	149 participants n=7 Participants	299 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Any pain at five years

Outcome measures

Measure	Prolene Hernia System Device n=122 Participants Inguinal hernia repair either with a bilayer mesh (PHS) Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique Prolene Hernia System: Prolene Hernia System	Lichtenstein n=110 Participants Inguinal hernia repair with the Lichtenstein technique Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique Lichtenstein technique: Lichtenstein technique
Long-term Sequelae	10 percentage of participants	13 percentage of participants

Adverse Events

Prolene Hernia System Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lichtenstein

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Georgios Pierides

Helsinki University Central Hospital

Phone: +358 9 4711

Email: georgios.pierides@hus.fi

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place