NCT05879770

Brief Summary

When conducting the Shouldice procedure the 4-layer suture of the transversalis fascia is usually done with Prolene worldwide. At the Shouldice hospital the wire has originally been used for these augmentation. During the last decade several Shouldice Surgeons started to use the Prolene due to occasional delivery problems of the wire from Germany. The 1-year- recurrence rate at the Shouldice hospital is 1,15% (mainly wire-use). The published 1-year recurrence rate in Europe is 2%. As quality assessment, this project intends to evaluate these two options for suturing (wire vs Prolene) in the elective inguinal hernia patient in terms of 1-year recurrence rate. The population of focus will be those who had a primary or secondary inguinal hernia operation at Shouldice Hospital and the project is estimated to take 3 months.

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
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 18, 2023

Last Update Submit

May 18, 2023

Conditions

Inguinal Hernia

Keywords

Hernia, Shouldice Repair, groin hernia

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

    One-year recurrence rate

    1 year

Secondary Outcomes (1)

  • Reoperation rate due to a recurrence

    1 year

Study Arms (2)

Wire group

Patients who underwent Shouldice inguinal hernia repair using wire.

Other: suture material

prolene group

Patients who underwent Shouldice inguinal hernia repair using prolene.

Other: suture material

Interventions

suture materialOTHER

Some patients have had a shouldice repair with wire in the past and others with Prolene.

Wire groupprolene group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients of all sexes who have undergone inguinal hernia surgery in Shouldice technique.

You may qualify if:

  • Adult patients of all sexes who have undergone inguinal hernia surgery in Shouldice technique.

You may not qualify if:

  • Hernia repair using a mesh

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shouldice Hospital

Thornhill, Ontario, L3T 4A3,, Canada

RECRUITING

MeSH Terms

Conditions

Hernia, InguinalHernia

Interventions

Sutures

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 30, 2023

Study Start

September 1, 2023

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

May 30, 2023

Record last verified: 2023-05

Locations

CA(1)