Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05863624
• Other study ID #: KUH5200667
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2023
• Source: Kuopio University Hospital
• Contact: Hannu EK Paajanen, MD
• Phone: 0405263101
• Email: paajanen[@]surffi.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• primary inguinal hernia in females

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hernia, Inguinal
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Open hernioplasty
Inguinal hernia is operated using open surgery
• TEP hernioplasty
Inguinal hernia is operated using laparoendoscopic technique

Locations

Country	Name	City	State
Finland	Mikkeli Central Hospital	Mikkeli

Sponsors (6)

Lead Sponsor	Collaborator
Kuopio University Hospital	Helsinki University Central Hospital, Jyväskylä Central Hospital, Mikkeli Central Hospital, North Karelia Central Hospital, Päijänne Tavastia Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain	Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery	from 1 week to one year
Secondary	Complications	Postoperative complications of surgery (wound infection, hemorrhage)	1 month
Secondary	Recurrence	Hernia recurrences after 5 years	5 years
Secondary	Sick leave	how many days the patient is not working after surgery	0-30 days
Secondary	Treatment costs	how much in euros the surgical treatment will cost	0-30 days