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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrocoagulation | Patients will undergo a standard procedure for inguinal hernia repair, with the use of electrocoagulation. |
| |
| No electrocoagulation | Patients will undergo a standard procedure for inguinal hernia repair, without the use of electrocoagulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inguinal hernia repair | Procedure | Standard procedure for inguinal hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery time | The surgery time (skin to skin) will be measured in all patients (in minutes). | 12 months |
| Scrotal hematoma | The presence of scrotal hematoma (yes/no) will be assessed in all patients. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients indicated for an inguinal hernia surgical repair.
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| Name | Affiliation | Role |
|---|---|---|
| Petr Ostruszka, MD | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava-Poruba | Czech Republic | 708 52 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16482060 | Background | 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. | |
| 9574303 | 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. |
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The investigators have not decided to share the IPD with other researchers.
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D000084462 | Hyperthermia |
| D010149 | Pain, Postoperative |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 12 months |
| Seroma | The presence of seroma (yes/no) will be assessed in all patients. | 12 months |
| 8800051 | 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. |
| 10945356 | 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. |
| 23389072 | 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. |
| 22083332 | 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. |
| 25377757 | 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. |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |