Inguinal HerniaNCT03566784
Electrocoagulation Employment During TAPP Inguinal Hernia Repair
An observational study of Inguinal Hernia, run by University Hospital Ostrava at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Inguinal hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients indicated for an inguinal hernia surgical repair.
Who may be able to join
- age ≥18 years
- unilateral inguinal hernia
- no previous intraabdominal operations
- no history of neurological diseases
Who cannot join
- recurrent inguinal hernia
- bilateral inguinal hernia
- history of chronic pain syndrome
- preoperative ASA classification IV-V
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava-Poruba, Czech Republic, 708 52
About this study
Official title: 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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Inguinal hernia repair
- Keywords
- inguinal hernia repair, electrocoagulation, postoperative pain, thermal injury, neuralgia
- Medical subject headings
- Hernia, Inguinal, Hyperthermia, Pain, Postoperative, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal hernia repairProcedure or surgery
Standard procedure for inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Electrocoagulation | Patients will undergo a standard procedure for inguinal hernia repair, with the use of electrocoagulation. Receives: Procedure: Inguinal hernia repair | |
| No electrocoagulation | Patients will undergo a standard procedure for inguinal hernia repair, without the use of electrocoagulation. Receives: Procedure: Inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Surgery time
The surgery time (skin to skin) will be measured in all patients (in minutes).
Measured: 12 months
Scrotal hematoma
The presence of scrotal hematoma (yes/no) will be assessed in all patients.
Measured: 12 months
Seroma
The presence of seroma (yes/no) will be assessed in all patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 Jun 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petr Ostruszka, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566784
- Sponsor's protocol ID
- CHIR-02-Electrocoagulation
- Status last verified
- Oct 2020
- First submitted
- 12 Jun 2018
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not decided to share the IPD with other researchers.
Publications
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.
PubMed 16482060Bittner R, Leibl B, Kraft K. [Laparoscopic hernia repair: prevention and therapy of complications]. Langenbecks Arch Chir Suppl Kongressbd. 1997;114:935-8. German.
PubMed 9574303Zohar 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.
PubMed 8800051Lee 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.
PubMed 10945356Bansal 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.
PubMed 23389072Singh 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.
PubMed 22083332Cesmebasi 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.
PubMed 25377757
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocoagulation Employment During TAPP (Transabdominal Preperitoneal Approach) Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT03566784
- Acronym / sponsor ID
- CHIR-02-Electrocoagulation
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia repair, electrocoagulation, postoperative pain, thermal injury, neuralgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrocoagulation | – | Procedure: Inguinal hernia repairPatients will undergo a standard procedure for inguinal hernia repair, with the use of electrocoagulation. |
| No electrocoagulation | – | Procedure: Inguinal hernia repairPatients will undergo a standard procedure for inguinal hernia repair, without the use of electrocoagulation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for an inguinal hernia surgical repair.
Key inclusion criteria (4 listed)
- age ≥18 years
- unilateral inguinal hernia
- no previous intraabdominal operations
- no history of neurological diseases
Key exclusion criteria (4 listed)
- recurrent inguinal hernia
- bilateral inguinal hernia
- history of chronic pain syndrome
- preoperative ASA classification IV-V
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inguinal hernia repairStandard procedure for inguinal hernia repair | Procedure or surgery | Electrocoagulation, No electrocoagulation |
Primary outcome
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.
3 secondary outcomes
Surgery time
Time frame: 12 months
Scrotal hematoma
Time frame: 12 months
Seroma
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Background: PubMed 16482060Archvadze 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.
- Background: PubMed 9574303Bittner R, Leibl B, Kraft K. [Laparoscopic hernia repair: prevention and therapy of complications]. Langenbecks Arch Chir Suppl Kongressbd. 1997;114:935-8. German.
- Background: PubMed 8800051Zohar 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.
- Background: PubMed 10945356Lee 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.
- Background: PubMed 23389072Bansal 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.
- Background: PubMed 22083332Singh 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.
- Background: PubMed 25377757Cesmebasi 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.
- Individual participant dataSharing planned: Undecided. The investigators have not decided to share the IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Ostruszka, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative neuralgia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03566784, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.