Electrocoagulation Employment During TAPP Inguinal Hernia Repair

October 5, 2020 updated by: University Hospital Ostrava

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Ostrava-Poruba, Czech Republic, Czechia, 708 52
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients indicated for an inguinal hernia surgical repair.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative neuralgia
Time Frame: 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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Petr Ostruszka, MD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

June 12, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHIR-02-Electrocoagulation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The investigators have not decided to share the IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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