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Electrocoagulation Employment During TAPP Inguinal Hernia Repair

U

University Hospital Ostrava

Status

Completed

Conditions

Inguinal Hernia

Treatments

Procedure: Inguinal hernia repair

Study type

Observational

Funder types

Other

Identifiers

NCT03566784
CHIR-02-Electrocoagulation

Details and patient eligibility

About

Laparoscopic TAPP (transabdominal preperitoneal) hernia repair presents a minimally invasive surgical procedure, which tends to be a gold standard in a wide range of inguinal hernia operations. Postoperative neuralgia is a troublesome complication following TAPP, which occurs in 0.2-7% of patients. The most common cause of nerve injury is an inappropriate use of electrocoagulation or dangerous tissue dissection during TAPP. However, the association between electrocoagulation employment during TAPP and postoperative neuralgia has not been investigated properly until now.

The aim of the project is to compare postoperative pain (postoperative neuralgia) in patients undergoing TAPP inguinal hernia repair with/without the use of electrocoagulation.

Full description

Worldwide, more than 20 million patients undergo inguinal hernia repair annually. Laparoscopic hernia repair presents a minimally invasive surgical procedure, which tends to be a gold standard for inguinal hernia repair. In comparison with open techniques of hernia repair, TAPP approach requires a totally different anatomic point of view. The operating surgeon must understand the basic principles and technical key points of TAPP in order to ensure satisfactory surgical outcomes and to prevent the occurrence of complications.

Postoperative neuralgia presents a troublesome complication following TAPP, which occurs in 0.2-7% of patients. Neuralgia is caused by intraoperative injury of genitofemoral, ilioinguinal, iliohypogastric or cutaneous femoris lateralis nerves (genitofemoral nerve being is the most often damaged). During TAPP, the most frequent causes of neural injury include clip application, inappropriate use of electrocoagulation or dangerous tissue dissection. At present, the employment of modern self-gripping meshes and tissue glues leave the use of electrocoagulation the main risk factor for potential nerve injury.

The aim of the proposed project is to evaluate postoperative pain (postoperative neuralgia) in patients undergoing TAPP inguinal hernia repair with/without the use of electrocoagulation. The assessment of the pain in the groin region will be performed on the 2nd and 7th postoperative day by means of clinical examination and by fulfilling the visual scale of pain. In patients showing clinical signs of postoperative neuralgia on the 7th postoperative day, clinical examination by an experienced neurologist will be performed.

Enrollment

100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age ≥18 years
  • unilateral inguinal hernia
  • no previous intraabdominal operations
  • no history of neurological diseases

Exclusion criteria

  • recurrent inguinal hernia
  • bilateral inguinal hernia
  • history of chronic pain syndrome
  • preoperative ASA classification IV-V

Trial design

100 participants in 2 patient groups

Electrocoagulation
Description:
Patients will undergo a standard procedure for inguinal hernia repair, with the use of electrocoagulation.
Treatment:
Procedure: Inguinal hernia repair
No electrocoagulation
Description:
Patients will undergo a standard procedure for inguinal hernia repair, without the use of electrocoagulation.
Treatment:
Procedure: Inguinal hernia repair

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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