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Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

Primary Purpose

Post Operative Pain

Status

Not yet recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Open hernioplasty

TEP hernioplasty

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: primary inguinal hernia in females Exclusion Criteria: emergency operation recurrent hernia groin pain without hernia frail and sick patient ASA ≥ 4

Sites / Locations

Mikkeli Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Open hernioplasty

TEP hernioplasty

Arm Description

Open Lichtenstein hernia repair

totally endoscopic hernia repair (TEP)

Outcomes

Primary Outcome Measures

Chronic pain

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

Secondary Outcome Measures

Complications

Postoperative complications of surgery (wound infection, hemorrhage)

Recurrence

Hernia recurrences after 5 years

Sick leave

how many days the patient is not working after surgery

Treatment costs

how much in euros the surgical treatment will cost

Full Information

NCT ID

NCT05863624

First Posted

April 17, 2023

Last Updated

July 31, 2023

Sponsor

Kuopio University Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05863624

Brief Title

Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2023 (Anticipated)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kuopio University Hospital

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized follow-up study

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Open hernioplasty

Arm Type

Experimental

Arm Description

Open Lichtenstein hernia repair

Arm Title

TEP hernioplasty

Arm Type

Active Comparator

Arm Description

totally endoscopic hernia repair (TEP)

Intervention Type

Procedure

Intervention Name(s)

Open hernioplasty

Other Intervention Name(s)

Open Lichtenstein hernia repair

Intervention Description

Inguinal hernia is operated using open surgery

Intervention Type

Procedure

Intervention Name(s)

TEP hernioplasty

Other Intervention Name(s)

totally endoscopic hernia repair (TEP)

Intervention Description

Inguinal hernia is operated using laparoendoscopic technique

Primary Outcome Measure Information:

Title

Chronic pain

Description

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 Outcome Measure Information:

Title

Complications

Description

Postoperative complications of surgery (wound infection, hemorrhage)

Time Frame

1 month

Title

Recurrence

Description

Hernia recurrences after 5 years

Time Frame

5 years

Title

Sick leave

Description

how many days the patient is not working after surgery

Time Frame

0-30 days

Title

Treatment costs

Description

how much in euros the surgical treatment will cost

Time Frame

0-30 days

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

This study includes only females

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: primary inguinal hernia in females Exclusion Criteria: emergency operation recurrent hernia groin pain without hernia frail and sick patient ASA ≥ 4

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hannu EK Paajanen, MD

Phone

0405263101

Ext

+358

paajanen@surffi.fi

Facility Information:

Facility Name

Mikkeli Central Hospital

City

Mikkeli

ZIP/Postal Code

50100

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

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