NCT01699971

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
Last Updated

October 4, 2012

Status Verified

September 1, 2012

Enrollment Period

2.4 years

First QC Date

October 1, 2012

Last Update Submit

October 3, 2012

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • postoperatively pain

    Visual analog scale (VAS)

    Postoperative 36 month

Secondary Outcomes (2)

  • Quality of life

    36 month postoperative

  • frequency of recurrencies

    postopertive 36 month

Study Arms (1)

Lichtenstein

ACTIVE COMPARATOR

Hernia repair with lichtenstein propylene mesh

Procedure: Hernia repair

Interventions

Hernia repairPROCEDURE

Hernia repair admodum Lichtenstein with polypropylene mesh

Lichtenstein

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • unilateral primary hernia
  • open surgery

You may not qualify if:

  • Recurrent Hernia
  • Bilateral Hernia
  • laparoscopic surgery
  • Female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ersta Hospital

Stockholm, 116 91, Sweden

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Officials

  • Anders Thorell, Assoc Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc prof

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 4, 2012

Study Start

October 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2012

Last Updated

October 4, 2012

Record last verified: 2012-09

Locations

SE(1)