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CompletedNCT01699971Updated Oct 4, 2012

Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair

An interventional study of Hernia repair and Hernia repair in Inguinal Hernia, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-10-04.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Male
01

Study summary

The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups

02

Conditions studied

  • Inguinal Hernia
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 160 is above the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 18-75 years
  • unilateral primary hernia
  • open surgery

Exclusion criteria

Exclusion Criteria:

  • Recurrent Hernia
  • Bilateral Hernia
  • laparoscopic surgery
  • Female
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
160 participants (actual)

Study arms

  • Active comparator
    Lichtenstein

    Hernia repair with lichtenstein propylene mesh

    Procedure: Hernia repair

Interventions

  • ProcedureHernia repair

    Hernia repair admodum Lichtenstein with polypropylene mesh

  • ProcedureHernia repair

    Hernia repair with Ultra Pro Hernia System (UHS)

  • ProcedureHernia repair

    Hernia repair with Prolene Hernia System(PHS)

06

What researchers measure

Primary outcomes

  1. postoperatively pain

    Visual analog scale (VAS)

    Time frame: Postoperative 36 month

Secondary outcomes

  1. Quality of life

    SF36

    Time frame: 36 month postoperative

  2. frequency of recurrencies

    check patients journal

    Time frame: postopertive 36 month

07

Study locations

1 site
  • Ersta Hospital
    Stockholm, 116 91, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01699971
Lead sponsor
Karolinska Institutet
Responsible party
Anders Thorell (Assoc prof, Karolinska Institutet) — Principal investigator
First posted
Oct 4, 2012
Start date
Oct 2006
Primary completion
Mar 2009
Completion
Mar 2012
Last update
Oct 4, 2012

Study contacts

Anders Thorell, Assoc Prof
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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