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Electrocoagulation Employment During TAPP Inguinal Hernia Repair

Electrocoagulation Employment During TAPP (Transabdominal Preperitoneal Approach) Inguinal Hernia Repair

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03566784
Enrollment
100
Registered
2018-06-25
Start date
2018-06-01
Completion date
2019-06-30
Last updated
2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

inguinal hernia repair, electrocoagulation, postoperative pain, thermal injury, neuralgia

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.

Interventions

PROCEDUREInguinal hernia repair

Standard procedure for inguinal hernia repair

Sponsors

University Hospital Ostrava
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative neuralgia12 monthsThe 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

MeasureTime frameDescription
Surgery time12 monthsThe surgery time (skin to skin) will be measured in all patients (in minutes).
Scrotal hematoma12 monthsThe presence of scrotal hematoma (yes/no) will be assessed in all patients.
Seroma12 monthsThe presence of seroma (yes/no) will be assessed in all patients.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026