Electrocoagulation Employment During TAPP Inguinal Hernia Repair

NCT03566784 | Completed

• 1 other identifier: CHIR-02-Electrocoagulation
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Postoperative neuralgia

  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 Outcomes (3)

• Surgery time

  12 months

• Scrotal hematoma

  12 months

• Seroma

  12 months

Study Arms (2)

Electrocoagulation

Patients will undergo a standard procedure for inguinal hernia repair, with the use of electrocoagulation.

Procedure: Inguinal hernia repair

No electrocoagulation

Patients will undergo a standard procedure for inguinal hernia repair, without the use of electrocoagulation.

Procedure: Inguinal hernia repair

Interventions

Inguinal hernia repair PROCEDURE

Standard procedure for inguinal hernia repair

Electrocoagulation; No electrocoagulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for an inguinal hernia surgical repair.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava-Poruba, Czech Republic, 708 52, Czechia

Location

Related Publications (7)

• Archvadze VSh, Chkhivadze TF, Giorgadze KI, Chanukvadze IM, Dzhikiia DT, Koberidze GI, Tsamalaidze AM. [Electrocoagulation in the surgery of inguinal hernias]. Khirurgiia (Mosk). 2006;(1):53-4. Russian.

  PMID: 16482060 BACKGROUND

• Bittner R, Leibl B, Kraft K. [Laparoscopic hernia repair: prevention and therapy of complications]. Langenbecks Arch Chir Suppl Kongressbd. 1997;114:935-8. German.

  PMID: 9574303 BACKGROUND

• Zohar Y, Sadov R, Strauss M, Djialdetti M. Ultrastructural study of peripheral nerve injury induced by monopolar and bipolar diathermy. Ann Otol Rhinol Laryngol. 1996 Sep;105(9):673-7. doi: 10.1177/000348949610500901.

  PMID: 8800051 BACKGROUND

• Lee CH, Dellon AL. Surgical management of groin pain of neural origin. J Am Coll Surg. 2000 Aug;191(2):137-42. doi: 10.1016/s1072-7515(00)00319-7.

  PMID: 10945356 BACKGROUND

• Bansal VK, Misra MC, Babu D, Victor J, Kumar S, Sagar R, Rajeshwari S, Krishna A, Rewari V. A prospective, randomized comparison of long-term outcomes: chronic groin pain and quality of life following totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) laparoscopic inguinal hernia repair. Surg Endosc. 2013 Jul;27(7):2373-82. doi: 10.1007/s00464-013-2797-7. Epub 2013 Feb 7.

  PMID: 23389072 BACKGROUND

• Singh AN, Bansal VK, Misra MC, Kumar S, Rajeshwari S, Kumar A, Sagar R, Kumar A. Testicular functions, chronic groin pain, and quality of life after laparoscopic and open mesh repair of inguinal hernia: a prospective randomized controlled trial. Surg Endosc. 2012 May;26(5):1304-17. doi: 10.1007/s00464-011-2029-y. Epub 2011 Nov 15.

  PMID: 22083332 BACKGROUND

• Cesmebasi A, Yadav A, Gielecki J, Tubbs RS, Loukas M. Genitofemoral neuralgia: a review. Clin Anat. 2015 Jan;28(1):128-35. doi: 10.1002/ca.22481. Epub 2014 Nov 5.

  PMID: 25377757 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Hyperthermia; Pain, Postoperative; Neuralgia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Petr Ostruszka, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: June 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

CZ (1)