Study of Laparoscopic Inguinal Hernia Repair

Medical Park Gaziantep Hospital

Status: Completed

Conditions: Neuralgia, Ilioinguinal; Hernia, Femoral; Neuralgia, Iliohypogastric Nerve; Hernia, Inguinal; Inguinal Hernia, Direct; Neuralgia, Atypical; Inguinal Hernia, Indirect; Recurrence

Treatments: Procedure: TEP without fixation; Procedure: TEP with fixation; Procedure: TAPP with fixation; Procedure: TAPP without fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT02920307

MK-002-LHR

Details and patient eligibility

About

Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.

Full description

A randomized prospective study was conducted. Four groups of patients were constituted: (1) TEP with mesh fixation (2) TEP without fixation, (3) TAPP with mesh fixation, (4) TAPP without fixation. 120 patients were randomized to each group. The principal outcomes assessed were postoperative chronic groin pain assessed by visual analogue pain scale (VAS), hernia recurrence, other morbidity rates and hospital costs. Patients were reviewed in outpatient unit at 1 week and at 1, 6, 12 and 24 months.

Enrollment: 400 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• unilateral hernia
• uncomplicated hernia
• medical fitness for general anesthesia

Exclusion criteria

• unfit for general anesthesia
• complicated hernia
• uncorrectable coagulopathy
• BMI > 35
• concomitant pathologies requiring simultaneous surgery
• bilateral hernia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 4 patient groups

TEP without fixation

Experimental group

Description:

Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair without mesh fixation

Treatment:

Procedure: TEP without fixation

TEP with fixation

Active Comparator group

Description:

Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair

Treatment:

Procedure: TEP with fixation

TAPP without fixation

Experimental group

Description:

Standard transabdominal preperitoneal (TAPP) hernia repair without mesh fixation

Treatment:

Procedure: TAPP without fixation

TAPP with fixation

Active Comparator group

Description:

Standard transabdominal preperitoneal (TAPP) hernia repair

Treatment:

Procedure: TAPP with fixation