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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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
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 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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT02920307
Study groupRoleWhat they receive
TEP without fixationExperimentalStandard totally extraperitoneoscopic preperitoneal (TEP) hernia repair without mesh fixation
Receives: Procedure: TEP without fixation
TEP with fixationActive comparatorStandard totally extraperitoneoscopic preperitoneal (TEP) hernia repair
Receives: Procedure: TEP with fixation
TAPP without fixationExperimentalStandard transabdominal preperitoneal (TAPP) hernia repair without mesh fixation
Receives: Procedure: TAPP without fixation
TAPP with fixationActive comparatorStandard 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.

  1. Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS)

    neuralgia, inguinal

    Measured: preoperative and postoperative 2nd year

  2. Change from preoperative pain levels at 1 year assessed by the VAS

    neuralgia, inguinal

    Measured: preoperative and postoperative 1st year

  3. Change from preoperative pain levels at 6 months assessed by the VAS

    neuralgia, inguinal

    Measured: preoperative and postoperative 6th month

  4. Change from preoperative pain levels at 3 months assessed by the VAS

    neuralgia, inguinal

    Measured: preoperative and postoperative 3th month

  5. Change from preoperative pain levels at 1 month assessed by the VAS

    neuralgia, inguinal

    Measured: preoperative and postoperative 1 month

  6. Change from preoperative pain levels at 1 week assessed by the VAS

    neuralgia, inguinal

    Measured: preoperative and postoperative 1th week

Secondary outcomes (4)

  1. Total hospital costs

    consisted all costs of hospital stays and outpatient treatments

    Measured: up to 24 months

  2. conversion rate

    conversion to open surgery

    Measured: through the first day

  3. recurrence rate

    clinical and radiological diagnosed

    Measured: up to 24 months

  4. 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.

  1. First posted30 Sep 2016 (estimated)
  2. Study startMay 2010
  3. Primary completionSep 2014
  4. Study completionSep 2016

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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).

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 3 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: finished, as of the sponsor's last update on 30 Sep 2016. 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 Turkey (Türkiye). 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?

Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS) (time frame: preoperative and postoperative 2nd year). The study lists 6 primary outcomes in all. 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 NCT02920307.

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 30 Sep 2016.

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