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Hernia, InguinalNCT05504122

Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique

A study testing inguinal hernia repair in people with Hernia, Inguinal, run by Kocaeli Derince Education and Research Hospital.

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

Open tension-free mesh repair (Lichtenstein) and laparoscopic totally extraperitoneal (TEP) repair are the most commonly preferred techniques for inguinal hernia surgery. There's still a debate going on about which of these two techniques (open versus laparoscopic) is effective. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hernia, Inguinal
What is being tested?
inguinal hernia repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
No sites listed yet
Study dates
1 Jan 2012to 1 Jan 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who were diagnosed with inguinal hernia (primary, recurrent, unilateral, bilateral)
  • American Society of Anesthesiologists (ASA) score of I and II
  • Gave informed consent to participate in the study

Who cannot join

  • Patients with scrotal, strangulated, or obstructed hernia
  • Periumbilical or subumbilical incision scar (median, right or left paramedian)
  • Undergoing prostatectomy or abdominal bladder surgery
  • Pfannenstiel incision scar
  • ASA score >3

About this study

Official title: Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique in Long-term Follow-up

Open tension-free mesh repair (Lichtenstein) and laparoscopic totally extraperitoneal (TEP) repair are the most commonly preferred techniques for inguinal hernia surgery. There's still a debate going on about which of these two techniques (open versus laparoscopic) is effective. This prospective randomized study aimed at comparing the early and long-term results of these two techniques (TEP vs. Lichtenstein).

Read the detailed description

Various studies comparing the laparoscopic totally extraperitoneal (TEP) and Lichtenstein techniques have been reported. These studies have shown that TEP repair is associated with less postoperative pain and faster recovery. However, there are different views on the long-term (recurrence, chronic pain, etc.) results of the two techniques. This study was designed to compare the short- and long-term outcomes of open tension-free mesh repair technique(Lichtenstein) and laparoscopic repair technique(TEP).

Being tested
inguinal hernia repair
Keywords
hernia, laparoscopic, Lichtenstein
Medical subject headings
Hernia, Inguinal, Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • inguinal hernia repairProcedure or surgery

    Patients who will undergo inguinal hernia repair will be divided into two groups(TEP versus Lichtenstein) according to the technique to be applied

Study groups in NCT05504122
Study groupRoleWhat they receive
Laparoscopic Totally Extraperitoneal (TEP)Active comparatorPatients who underwent Laparoscopic Totally Extraperitoneal (TEP) will be included in this group.
Receives: Procedure: inguinal hernia repair
Open tension-free mesh repair technique (Lichtenstein)Placebo comparatorPatients with open tension-free inguinal hernia(Lichtenstein) repair will be included in this group.
Receives: Procedure: inguinal hernia repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative complication status

    number of patients with complications

    Measured: up to the first 10 days postoperatively

  2. early period complication status

    number of patients with complications

    Measured: up to the first 3 months postoperatively

  3. late period complication status

    number of patients with complications

    Measured: Postoperative 3rd to 84th month

  4. early recurrence rate

    number of patients with recurrence

    Measured: up to the first 3 months postoperatively

  5. late recurrence rate

    number of patients with recurrence

    Measured: Postoperative 3rd to 84th month

Secondary outcomes (4)

  1. Visual Analog Score for pain

    Units on a Scale; 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-9: severe pain, 10: worst pain possible.

    Measured: postoperative 24th hour

  2. total analgesic requirement

    the number of analgesics used.

    Measured: postoperative 1 to 10 days

  3. time to return to work after surgery

    day

    Measured: Postoperative 3rd month

  4. early complication status

    Number of patients with complications

    Measured: postoperative 1st month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2022
  2. Study start1 Jan 2012
  3. Primary completion31 Dec 2014
  4. Study completion1 Jan 2022

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05504122
Sponsor's protocol ID
KOU KAEK 2012/161-17/14
Status last verified
Aug 2022
First submitted
31 Jul 2022
Last updated
17 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Langeveld HR, van't Riet M, Weidema WF, Stassen LP, Steyerberg EW, Lange J, Bonjer HJ, Jeekel J. Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial. Ann Surg. 2010 May;251(5):819-24. doi: 10.1097/SLA.0b013e3181d96c32.

    PubMed 20395851

  • Eklund AS, Montgomery AK, Rasmussen IC, Sandbue RP, Bergkvist LA, Rudberg CR. Low recurrence rate after laparoscopic (TEP) and open (Lichtenstein) inguinal hernia repair: a randomized, multicenter trial with 5-year follow-up. Ann Surg. 2009 Jan;249(1):33-8. doi: 10.1097/SLA.0b013e31819255d0.

    PubMed 19106673

  • O'Reilly EA, Burke JP, O'Connell PR. A meta-analysis of surgical morbidity and recurrence after laparoscopic and open repair of primary unilateral inguinal hernia. Ann Surg. 2012 May;255(5):846-53. doi: 10.1097/SLA.0b013e31824e96cf.

    PubMed 22470068

Questions about this trial

What is this clinical trial studying?

A study testing inguinal hernia repair in people with Hernia, Inguinal, run by Kocaeli Derince Education and Research Hospital.

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 5 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 17 Aug 2022. 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. Some participants in this study may receive a placebo. 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 complication status (time frame: up to the first 10 days postoperatively). The study lists 5 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 NCT05504122, which also lists 3 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 17 Aug 2022.

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