Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients

Mehmet Eşref Ulutaş

Status: Enrolling

Conditions: Postoperative Complications; Urinary Retention; Relapse; Pain

Treatments: Procedure: Laparoscopic TEP Repair; Procedure: Open Technique (Lichtenstein)

Study type: Interventional

Funder types: Other

Identifiers

NCT06417346

65646564

Details and patient eligibility

About

Inguinal hernia is one of the most frequently performed surgeries in general surgery. This surgery can be performed with both open and laparoscopic techniques. There is no clear consensus on whether inguinal hernia repair, which is one of the most frequently performed surgeries in elderly patients, should be performed open or laparoscopic. The application of the open technique with regional anesthesia methods such as spinal anesthesia and local anesthesia makes these methods attractive. The fact that laparoscopic techniques cause patients to recover faster also makes these techniques attractive. However, the fact that it is usually performed under general anesthesia is a significant disadvantage. Increasing comorbidities and increased drug use, especially in elderly patients, make surgeons think about which technique to prefer. The aim of this study is to compare open and laparoscopic inguinal hernia repair, which should be preferred in patients over 65 years of age.

Enrollment: 160 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with inguinal hernias.
• Patients aged over 65.

Exclusion criteria

• Younger than 65 years.
• Incarcerated or strangulated inguinal hernias.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Laparoscopic TEP Repair under General Anesthesia

Experimental group

Description:

A mini-incision was made at the umbilical margin, passing through the skin and subcutaneous tissue to expose the external sheath of the rectus muscle. The RS was incised, and the rectus muscle was laterally displaced. A 10-mm trocar was inserted into the preperitoneal space, and CO2 insufflation was performed with a pressure set at 12 mmHg. Two additional 5 mm trocars were inserted between the umbilicus and the symphysis pubis under laparoscopic guidance. Using laparoscopic dissectors and graspers, all steps of myopectineal orifice dissection were performed (16). A 15 × 10 cm prolene mesh was spread and secured to cover both direct and indirect hernia areas, extending approximately 2-3 cm beyond. Trocars were removed under camera surveillance after CO2 desufflation, and the skin was closed.

Treatment:

Procedure: Laparoscopic TEP Repair

Open Technique (Lichtenstein) under Spinal Anesthesia

Active Comparator group

Description:

Following a classic inguinal incision of approximately 5-7 cm extending laterally from the pubic tubercle, the external oblique aponeurosis was opened, the external ring was disrupted, and the spermatic cord/round ligament was suspended. The hernia sac was isolated from surrounding tissues and the spermatic cord/round ligament, then either reduced or ligated. Subsequently, a polypropylene mesh measuring approximately 60x110 mm² was placed to completely cover the transverse fascia, and continuous sutures were used to secure it laterally along the transverse arch starting from the pubic tubercle. Hemostasis was achieved, and the layers and skin were anatomically closed.

Treatment:

Procedure: Open Technique (Lichtenstein)