Electrocoagulation Employment During TAPP Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566784
• Other study ID #: CHIR-02-Electrocoagulation
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2020
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Inguinal hernia repair
Standard procedure for inguinal hernia repair

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava-Poruba	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & 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. — View Citation

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. — View Citation

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

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. Review. — View Citation

Lee CH, Dellon AL. Surgical management of groin pain of neural origin. J Am Coll Surg. 2000 Aug;191(2):137-42. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgery time	The surgery time (skin to skin) will be measured in all patients (in minutes).	12 months
Secondary	Scrotal hematoma	The presence of scrotal hematoma (yes/no) will be assessed in all patients.	12 months
Secondary	Seroma	The presence of seroma (yes/no) will be assessed in all patients.	12 months