Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

March 5, 2024 updated by: Kuopio University Hospital

Postoperative Pain and Recurrences After Totally Extraperitoneal Endoscopic (TEP) vs. Lichtenstein Hernioplasty in Female Inguinal Hernia Repair: a Prospective Randomized Multi-center Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Mikkeli, Finland, 50100
        • Mikkeli Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • primary inguinal hernia in females

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TEP hernioplasty
totally endoscopic hernia repair (TEP)
Procedure: TEP hernioplasty
Inguinal hernia is operated using laparoendoscopic technique
Other Names:
  • totally endoscopic hernia repair (TEP)
Experimental: Open hernioplasty
Open Lichtenstein hernia repair
Procedure: Open hernioplasty
Inguinal hernia is operated using open surgery
Other Names:
  • Open Lichtenstein hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from 1 week to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 1 month
Postoperative complications of surgery (wound infection, hemorrhage)
1 month
Recurrence
Time Frame: 5 years
Hernia recurrences after 5 years
5 years
Sick leave
Time Frame: 0-30 days
how many days the patient is not working after surgery
0-30 days
Treatment costs
Time Frame: 0-30 days
how much in euros the surgical treatment will cost
0-30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

Helsinki University Central Hospital
Päijänne Tavastia Central Hospital
Jyväskylä Central Hospital
North Karelia Central Hospital
Mikkeli Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5200667

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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