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Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05863624
Recruitment Status : Not yet recruiting
First Posted : May 18, 2023
Last Update Posted : March 6, 2024
Sponsor:
Collaborators:
Helsinki University Central Hospital
Päijänne Tavastia Central Hospital
North Karelia Central Hospital
Jyväskylä Central Hospital
Mikkeli Central Hospital
Information provided by (Responsible Party):
Kuopio University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Procedure: Open hernioplasty Procedure: TEP hernioplasty Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized follow-up study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain and Recurrences After Totally Extraperitoneal Endoscopic (TEP) vs. Lichtenstein Hernioplasty in Female Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
Estimated Study Start Date : September 1, 2024
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open hernioplasty
Open Lichtenstein hernia repair
 Procedure: Open hernioplasty
Inguinal hernia is operated using open surgery
Other Name: Open Lichtenstein hernia repair
Active Comparator: TEP hernioplasty
totally endoscopic hernia repair (TEP)
 Procedure: TEP hernioplasty
Inguinal hernia is operated using laparoendoscopic technique
Other Name: totally endoscopic hernia repair (TEP)


Outcome Measures
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Primary Outcome Measures :
  1. Chronic pain [ Time Frame: from 1 week to one year ]
    Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery


Secondary Outcome Measures :
  1. Complications [ Time Frame: 1 month ]
    Postoperative complications of surgery (wound infection, hemorrhage)

  2. Recurrence [ Time Frame: 5 years ]
    Hernia recurrences after 5 years

  3. Sick leave [ Time Frame: 0-30 days ]
    how many days the patient is not working after surgery

  4. Treatment costs [ Time Frame: 0-30 days ]
    how much in euros the surgical treatment will cost


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study includes only females
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary inguinal hernia in females

Exclusion Criteria:

  • emergency operation
  • recurrent hernia
  • groin pain without hernia
  • frail and sick patient ASA ≥ 4
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05863624


Contacts
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Contact: Hannu EK Paajanen, MD 0405263101 ext +358 paajanen@surffi.fi

Locations
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Finland
Mikkeli Central Hospital
Mikkeli, Finland, 50100
Sponsors and Collaborators
Kuopio University Hospital
Helsinki University Central Hospital
Päijänne Tavastia Central Hospital
North Karelia Central Hospital
Jyväskylä Central Hospital
Mikkeli Central Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT05863624    
Other Study ID Numbers: KUH5200667
First Posted: May 18, 2023    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Hernia, Inguinal
Hernia
Pathological Conditions, Anatomical
Postoperative Complications
 Pathologic Processes
Pain
Neurologic Manifestations
Hernia, Abdominal