NCT02467140

Brief Summary

A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 9, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

June 4, 2015

Last Update Submit

June 5, 2015

Conditions

Inguinal HerniaPain

Keywords

Inguinal hernia repairHerniaProGrib self-fixating meshBiological meshTack fixation

Outcome Measures

Primary Outcomes (2)

  • Number of patients experiencing acute postoperative pain, using the NRS pain score.

    3 months

  • Number of patients with recurrent hernia.

    1 year

Secondary Outcomes (2)

  • Number of patients experiencing chronic postoperative pain, using the NRS pain score.

    1 year

  • Quality of life before and after surgery, using the Carolina Comfort Scale

    6 months

Study Arms (2)

Self-fixating mesh

ACTIVE COMPARATOR

During surgery, the Parietex ProGrib mesh will be used.

Device: Parietex ProGrib self-fixating mesh

Tack fixation

ACTIVE COMPARATOR

During surgery, the mesh will be fixated with tacks.

Device: Tack fixation

Interventions

Parietex ProGrib self-fixating meshDEVICE

Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh.

Self-fixating mesh
Tack fixationDEVICE

Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh using tack fixation.

Tack fixation

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for elective, inguinal hernia repair
  • years or older
  • Male gender
  • ASA physical classification system 1-3
  • Informed consent

You may not qualify if:

  • Patients with recurrent hernia, except patients operated in childhood without mesh application.
  • Patients with bilateral hernia
  • Patients with chronic pain
  • Patients in anticoagulation therapy
  • Previous major surgery in lower abdomen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospitalsenheden Midt

Viborg, Region Midt, 8800, Denmark

RECRUITING

MeSH Terms

Conditions

Hernia, InguinalPainHernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Michael F Nielsen, MD PhD

    STUDY DIRECTOR

Central Study Contacts

Malene O Dinesen, MD PhD

CONTACT

+45 42 29 00 23maledine@rm.dk

Marie K Christensen, MD

CONTACT

+45 40 79 54 59mariekirk@dadlnet.dk

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
SPONSOR

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 9, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

June 9, 2015

Record last verified: 2015-05

Locations

DK(1)