Hernia, InguinalNCT02920307
Study of Laparoscopic Inguinal Hernia Repair
A study testing TEP without fixation, TEP with fixation and TAPP without fixation in people with Hernia, Inguinal and Inguinal Hernia, Direct, run by Medical Park Gaziantep Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hernia, Inguinal, Inguinal Hernia, Direct, Inguinal Hernia, Indirect
- What is being tested?
- TEP without fixation, TEP with fixation and TAPP without fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2010to Sep 2016
- Phase
- Interventional
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- unilateral hernia
- uncomplicated hernia
- medical fitness for general anesthesia
Who cannot join
- unfit for general anesthesia
- complicated hernia
- uncorrectable coagulopathy
- BMI > 35
- concomitant pathologies requiring simultaneous surgery
- bilateral hernia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medical Park Gaziantep Hospital
Gaziantep, 27090
About this study
Official title: Prospective, Randomized and Controlled Study Comparing Fixation Versus no Fixation of Mesh in Laparoscopic Inguinal Hernia Repair
Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.
Read the detailed description
A randomized prospective study was conducted. Four groups of patients were constituted: (1) TEP with mesh fixation (2) TEP without fixation, (3) TAPP with mesh fixation, (4) TAPP without fixation. 120 patients were randomized to each group. The principal outcomes assessed were postoperative chronic groin pain assessed by visual analogue pain scale (VAS), hernia recurrence, other morbidity rates and hospital costs. Patients were reviewed in outpatient unit at 1 week and at 1, 6, 12 and 24 months.
- Conditions
- Hernia, Inguinal, Inguinal Hernia, Direct, Inguinal Hernia, Indirect, Hernia, Femoral, Recurrence, Neuralgia, Atypical
- Being tested
- TEP without fixation, TEP with fixation, TAPP without fixation, TAPP with fixation
- Keywords
- laparoscopic inguinal hernia repair, total extraperitoneoscopic hernia repair, transabdominal preperitoneal hernia repair, inguinal hernia, laparoscopy, hernia repair, herniorraphy, laparoscopic surgery
- Medical subject headings
- Hernia, Inguinal, Hernia, Femoral, Recurrence, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEP without fixationProcedure or surgery
Also called TEP no fixation
Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair
TEP with fixationProcedure or surgery
Also called Standard TEP
Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair
TAPP without fixationProcedure or surgery
Also called TAPP no fixation
Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation
TAPP with fixationProcedure or surgery
Also called Standard TAPP
Standard transabdominal preperitoneal (TAPP) inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| TEP without fixation | Experimental | Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair without mesh fixation Receives: Procedure: TEP without fixation |
| TEP with fixation | Active comparator | Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair Receives: Procedure: TEP with fixation |
| TAPP without fixation | Experimental | Standard transabdominal preperitoneal (TAPP) hernia repair without mesh fixation Receives: Procedure: TAPP without fixation |
| TAPP with fixation | Active comparator | Standard transabdominal preperitoneal (TAPP) hernia repair Receives: Procedure: TAPP with fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS)
neuralgia, inguinal
Measured: preoperative and postoperative 2nd year
Change from preoperative pain levels at 1 year assessed by the VAS
neuralgia, inguinal
Measured: preoperative and postoperative 1st year
Change from preoperative pain levels at 6 months assessed by the VAS
neuralgia, inguinal
Measured: preoperative and postoperative 6th month
Change from preoperative pain levels at 3 months assessed by the VAS
neuralgia, inguinal
Measured: preoperative and postoperative 3th month
Change from preoperative pain levels at 1 month assessed by the VAS
neuralgia, inguinal
Measured: preoperative and postoperative 1 month
Change from preoperative pain levels at 1 week assessed by the VAS
neuralgia, inguinal
Measured: preoperative and postoperative 1th week
Secondary outcomes (4)
Total hospital costs
consisted all costs of hospital stays and outpatient treatments
Measured: up to 24 months
conversion rate
conversion to open surgery
Measured: through the first day
recurrence rate
clinical and radiological diagnosed
Measured: up to 24 months
rate of minor and major complications
it was assessed as; no complication, minor complications, major complications and complications needed reoperation
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startMay 2010
- Primary completionSep 2014
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Park Gaziantep Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Muğla Sıtkı Koçman University, Bahçeşehir University
- Responsible party
- Principal investigator, Mehmet Kaplan, Medical Park Gaziantep Hospital
- Investigators
- Mehmet Kaplan, M.D., Principal investigator, Bahçeşehir Üniversitesi Tıp FakültesiOnder Ozcan, M.D., Study chair, Mugla University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920307
- Sponsor's protocol ID
- MK-002-LHR
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes