Electrocoagulation Employment During TAPP Inguinal Hernia Repair

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Inguinal hernia repair

• Registration Number: NCT03566784
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-25
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postoperative neuralgia	12 months	The patients will assess the postoperative neuralgia in the groin area using a questionnaire with a 5-point scale (1-5). The value of 1 indicates no pain, value 5 indicates the highest possible imaginable pain, as assessed by the patients.

Secondary Outcome Measures

Name	Time	Method
Surgery time	12 months	The surgery time (skin to skin) will be measured in all patients (in minutes).
Scrotal hematoma	12 months	The presence of scrotal hematoma (yes/no) will be assessed in all patients.
Seroma	12 months	The presence of seroma (yes/no) will be assessed in all patients.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava-Poruba, Czech Republic, Czechia