Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

Kuopio University Hospital

Status: Not yet enrolling

Conditions: Post Operative Pain

Treatments: Procedure: Open hernioplasty; Procedure: TEP hernioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT05863624

KUH5200667

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Open hernioplasty

Experimental group

Description:

Open Lichtenstein hernia repair

Treatment:

Procedure: Open hernioplasty

TEP hernioplasty

Active Comparator group

Description:

totally endoscopic hernia repair (TEP)

Treatment:

Procedure: TEP hernioplasty