Inguinal HerniaTAPP&TEPNCT02928146
Lichtenstein Versus TAPP and TEP in Groin Hernioplasty
A study testing Hernia Repair in people with Inguinal Hernia, run by Miroslaw Szura.
Trial summary
The aim of the study is to evaluate the effectiveness of various methods of inguinal hernia repair and to evaluate techniques of synthetic mesh fixation during laparoscopic and open hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Hernia Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- Phase
- Interventional
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male
- age: 18 - 65
- planned inguinal hernia repair using synthetic implant
- BMI range: 20-35 kg / m2
- written informed consent
Who cannot join
- prior midline laparotomy
- contraindications for general anaesthesia
- ASA > IV
- cirrhosis (Child B or C) or ascites
- active treatment with use of chemiotherapy
- incarcerated hernia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Lichtenstein Versus TAPP and TEP Techniques for Inguinal Hernia Repair
The aim of the study is to evaluate the effectiveness of various methods of inguinal hernia repair and to evaluate techniques of synthetic mesh fixation during laparoscopic and open hernia repair.
Read the detailed description
In modern literature there is no conclusive evidence for the superiority of endoscopic over open inguinal hernia repair techniques, due to the lack of prospective, multicenter, randomized studies involving a sufficient number of patients. Both Lichtenstein and TAPP/TEP techniques are widely used and accepted methods of treatment. The clinical significance of this study is to show the differences in the incidence of perioperative complications, the evaluation of postoperative pain, full recovery time and improving the quality of life. The diagnosis of inguinal hernia will be based on a physical examination performed by an experienced surgeon based on the medical history of the patient and, if necessary, on ultrasound examination of the abdominal wall. Random assignment of patients to one of three treatment arms will take place the day before the surgery using computer-generated randomization list. The operating surgeon will be determined prior to randomization. Each patient before the study will receive complete information about the study which will be explained in detail regarding all planned procedures, the patient will obtain answers to any questions. After explaining any doubts the patient will sign the informed consent to participate in the study, in the presence of the investigator. Patients will be divided into three groups - TAPP, TEP and Lichtenstein method. Patients treated by TAPP and Lichtenstein will be further divided into subgroups - fixation glue or stitching - Lichtenstein method; fixation glue, tackers or implantation without fixation - TAPP method. Patients will receive preoperative antibiotic prophylaxis with a single dose of cephalosporin. Patients undergoing surgery will be hospitalized in the Department of Surgery until the first postop day. In justified cases, hospitalization will be extended.
- Conditions
- Inguinal Hernia
- Being tested
- Hernia Repair
- Keywords
- TAPP, TEP, Lichtenstein, syntethic mesh, hernioplasty
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hernia RepairProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Lichtenstein technique | Active comparator | Lichtenstein inguinal hernia repair Receives: Procedure: Hernia Repair |
| TAPP | Active comparator | Transabdominal preperitoneal (TAPP) approach for inguinal hernia repair Receives: Procedure: Hernia Repair |
| TEP | Active comparator | Totally extraperitoneal (TEP) approach for inguinal hernia repair Receives: Procedure: Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications associated with wound
Wound infection with or without the need to remove the mesh, Wound necrosis, Hematoma or seroma in the wound.
Measured: 30 days after surgery
Secondary outcomes (1)
The frequency of conversions (from laparoscopic to open approach)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miroslaw Szura
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University, Holy Jan Grande Boni Fratres Hospital in Krakow, Stefan Zeromski Hospital in Kraków
- Responsible party
- Sponsor-investigator, Miroslaw Szura, Jagiellonian University
- Investigators
- Miroslaw Szura, MD, PhD, Study director, Department of Experimental and Clinical Surgery, Jagiellonian University Medical CollegeRafal Solecki, MD, PhD, Principal investigator, Department of Experimental and Clinical Surgery, Jagiellonian University Medical CollegeArtur Pasternak, MD,PhD, Principal investigator, Department of Anatomy, Jagiellonian University Medical CollegeJakub Łomnicki, MD, Principal investigator, Stefan Zeromski Hospital in Krakow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928146
- Sponsor's protocol ID
- Lichtenstein vs TAPP/TEP
- Acronym
- TAPP&TEP
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lichtenstein Versus TAPP and TEP Techniques for Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT02928146
- Acronym / sponsor ID
- TAPP&TEP / Lichtenstein vs TAPP/TEP
- Conditions
- Inguinal Hernia
- Keywords
- TAPP, TEP, Lichtenstein, syntethic mesh, hernioplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Miroslaw SzuraUniversity, hospital or other
- Collaborators
- Jagiellonian University, Holy Jan Grande Boni Fratres Hospital in Krakow, Stefan Zeromski Hospital in Kraków
- Study start
- Jan 2017
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Oct 2016 (estimated)
- 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.
The aim of the study is to evaluate the effectiveness of various methods of inguinal hernia repair and to evaluate techniques of synthetic mesh fixation during laparoscopic and open hernia repair.
Detailed description
In modern literature there is no conclusive evidence for the superiority of endoscopic over open inguinal hernia repair techniques, due to the lack of prospective, multicenter, randomized studies involving a sufficient number of patients. Both Lichtenstein and TAPP/TEP techniques are widely used and accepted methods of treatment. The clinical significance of this study is to show the differences in the incidence of perioperative complications, the evaluation of postoperative pain, full recovery time and improving the quality of life. The diagnosis of inguinal hernia will be based on a physical examination performed by an experienced surgeon based on the medical history of the patient and, if necessary, on ultrasound examination of the abdominal wall. Random assignment of patients to one of three treatment arms will take place the day before the surgery using computer-generated randomization list. The operating surgeon will be determined prior to randomization. Each patient before the study will receive complete information about the study which will be explained in detail regarding all planned procedures, the patient will obtain answers to any questions. After explaining any doubts the patient will sign the informed consent to participate in the study, in the presence of the investigator. Patients will be divided into three groups - TAPP, TEP and Lichtenstein method. Patients treated by TAPP and Lichtenstein will be further divided into subgroups - fixation glue or stitching - Lichtenstein method; fixation glue, tackers or implantation without fixation - TAPP method. Patients will receive preoperative antibiotic prophylaxis with a single dose of cephalosporin. Patients undergoing surgery will be hospitalized in the Department of Surgery until the first postop day. In justified cases, hospitalization will be extended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein technique | Active comparator | Procedure: Hernia RepairLichtenstein inguinal hernia repair |
| TAPP | Active comparator | Procedure: Hernia RepairTransabdominal preperitoneal (TAPP) approach for inguinal hernia repair |
| TEP | Active comparator | Procedure: Hernia RepairTotally extraperitoneal (TEP) approach for inguinal hernia repair |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male
- age: 18 - 65
- planned inguinal hernia repair using synthetic implant
- BMI range: 20-35 kg / m2
- written informed consent
Key exclusion criteria (6 listed)
- prior midline laparotomy
- contraindications for general anaesthesia
- ASA > IV
- cirrhosis (Child B or C) or ascites
- active treatment with use of chemiotherapy
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 |
|---|---|---|
| Hernia Repair | Procedure or surgery | Lichtenstein technique, TAPP, TEP |
Primary outcome
Post-operative complications associated with wound
Time frame: 30 days after surgery
Wound infection with or without the need to remove the mesh, Wound necrosis, Hematoma or seroma in the wound.
1 secondary outcome
The frequency of conversions (from laparoscopic to open approach)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Miroslaw Szura, MD, PhD study director
Department of Experimental and Clinical Surgery, Jagiellonian University Medical College
Rafal Solecki, MD, PhD principal investigator
Department of Experimental and Clinical Surgery, Jagiellonian University Medical College
Artur Pasternak, MD,PhD principal investigator
Department of Anatomy, Jagiellonian University Medical College
Questions about this trial
What is this clinical trial studying?
A study testing Hernia Repair in people with Inguinal Hernia, run by Miroslaw Szura.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miroslaw Szura, MD, PhD (609210030, msszura@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complications associated with wound (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2016.