Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorKuopio University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

primary inguinal hernia in females

Disqualifiers

emergency operation

recurrent hernia

groin pain without hernia

frail and sick patient ASA ≥ 4

Trial design

Design model

Parallel

Treatments tested in this trial

  • Open hernioplasty

    Procedure/Surgery

    Inguinal hernia is operated using open surgery

  • TEP hernioplasty

    Procedure/Surgery

    Inguinal hernia is operated using laparoendoscopic technique

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Open hernioplastyExperimental treatment 1 intervention
Group B: TEP hernioplastyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Chronic pain

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

Time frame
from 1 week to one year

Secondary outcomes

1

Complications

Postoperative complications of surgery (wound infection, hemorrhage)

Time frame
1 month
2

Recurrence

Hernia recurrences after 5 years

Time frame
5 years
3

Sick leave

how many days the patient is not working after surgery

Time frame
0-30 days
4

Treatment costs

how much in euros the surgical treatment will cost

Time frame
0-30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kuopio University Hospital

Lead sponsor

Helsinki University Central Hospital

Collaborator

Päijänne Tavastia Central Hospital

Collaborator

North Karelia Central Hospital

Collaborator

Jyväskylä Central Hospital

Collaborator

Mikkeli Central Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: