NCT05863624

Brief Summary

This randomized study compares open inguinal hernia repair (Lichtenstein hernioplasty) to endoscopic repair (TEP) in terms of chronic pain and recurrences in one and five years after operation.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress32%
Sep 2024Dec 2029

First Submitted

Initial submission to the registry

April 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Expected
Last Updated

March 6, 2024

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

April 17, 2023

Last Update Submit

March 5, 2024

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Chronic pain

    Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery

    from 1 week to one year

Secondary Outcomes (4)

  • Complications

    1 month

  • Recurrence

    5 years

  • Sick leave

    0-30 days

  • Treatment costs

    0-30 days

Study Arms (2)

Open hernioplasty

EXPERIMENTAL

Open Lichtenstein hernia repair

Procedure: Open hernioplasty

TEP hernioplasty

ACTIVE COMPARATOR

totally endoscopic hernia repair (TEP)

Procedure: TEP hernioplasty

Interventions

Open hernioplastyPROCEDURE

Inguinal hernia is operated using open surgery

Also known as: Open Lichtenstein hernia repair
Open hernioplasty
TEP hernioplastyPROCEDURE

Inguinal hernia is operated using laparoendoscopic technique

Also known as: totally endoscopic hernia repair (TEP)
TEP hernioplasty

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study includes only females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary inguinal hernia in females

You may not qualify if:

  • emergency operation
  • recurrent hernia
  • groin pain without hernia
  • frail and sick patient ASA ≥ 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mikkeli Central Hospital

Mikkeli, 50100, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Hannu EK Paajanen, MD

CONTACT

0405263101paajanen@surffi.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized follow-up study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

May 18, 2023

Study Start

September 1, 2024

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2029

Last Updated

March 6, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)