Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

NCT ID: NCT05863624

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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The best operative technique in female inguinal hernia is not known. Some register studies recommend always laparoscopic hernia repair in females, but there are no randomized studies to show that laparoscopic repair is better than open hernioplasty. Our study compares operative complications, chronic pain and recurrences in Lichtenstein operation to totally endoscopic hernia repair (TEP) in 170 female patients with primary inguinal hernia. The patients are operated in six Finnish hospitals, randomized into 85 Lichtenstein vs 85 TEP and followed 1 week, 4 weeks, 12 months and 5 years. Main end-point in postoperative pain after one year, sencondary endpoints are sick leave, return to normal physical activity, complications of treatment, re-operations, chronic pain and costs of treatment.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized follow-up study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Open hernioplasty

Open Lichtenstein hernia repair

Group Type EXPERIMENTAL

Open hernioplasty

Intervention Type PROCEDURE

Inguinal hernia is operated using open surgery

TEP hernioplasty

totally endoscopic hernia repair (TEP)

Group Type ACTIVE_COMPARATOR

TEP hernioplasty

Intervention Type PROCEDURE

Inguinal hernia is operated using laparoendoscopic technique

Interventions

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Open hernioplasty

Inguinal hernia is operated using open surgery

Intervention Type PROCEDURE

TEP hernioplasty

Inguinal hernia is operated using laparoendoscopic technique

Intervention Type PROCEDURE

Other Intervention Names

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Open Lichtenstein hernia repair totally endoscopic hernia repair (TEP)

Eligibility Criteria

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Inclusion Criteria

* primary inguinal hernia in females

Exclusion Criteria

* emergency operation
* recurrent hernia
* groin pain without hernia
* frail and sick patient ASA ≥ 4
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Päijänne Tavastia Central Hospital

OTHER

Sponsor Role collaborator

North Karelia Central Hospital

OTHER

Sponsor Role collaborator

Jyväskylä Central Hospital

OTHER

Sponsor Role collaborator

Mikkeli Central Hospital

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mikkeli Central Hospital

Mikkeli, , Finland

Site Status

Countries

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Finland

Central Contacts

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Hannu EK Paajanen, MD

Role: CONTACT

0405263101 ext. +358

Other Identifiers

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KUH5200667

Identifier Type: -

Identifier Source: org_study_id

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