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Hernia, InguinalNCT04272424

Changing the Innate Consensus About Mesh Fixation in Trans-abdominal Preperitoneal Laparoscopic Inguinal Hernioplasty in Adults: Short and Long Term Outcome. Randomized Controlled Clinical Trial

A study testing laparoscopic mesh fixation in people with Hernia, Inguinal, run by Zagazig University.

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

Introduction: Inguinal hernioplasty is the standard treatment for inguinal hernia. Mesh fixation is used to keep mesh in place for which various mesh fixation techniques have been used in laparoscopic inguinal hernia repair, but their effectiveness has remained inconclusive. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Hernia, Inguinal
What is being tested?
laparoscopic mesh fixation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
No sites listed yet
Study dates
1 Jul 2016to 1 Jul 2018
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 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age ranging from 20 to 50
  • Both sex
  • An uncomplicated oblique inguinal hernia.
  • Unilateral hernia

Who cannot join

  • Patients younger than 20 or older than 50 year old
  • Patients with complicated hernia
  • Bilateral hernia
  • Recurrent hernia
  • Patients with previous lower abdominal surgery.

About this study

Introduction: Inguinal hernioplasty is the standard treatment for inguinal hernia. Mesh fixation is used to keep mesh in place for which various mesh fixation techniques have been used in laparoscopic inguinal hernia repair, but their effectiveness has remained inconclusive.

Aim of the work: Randomized comparative study comparing early and late outcome of different method of mesh fixation.

Methods: In Zagazig University Hospitals, over the period from July 2016 to July 2018, patients with with oblique inguinal hernias undergoing Tans abdominal preperitoneal technique were randomized into 3 groups: Group A; mesh non fixation . Group B; tacker mesh fixation Group C: Cyanoacrylic tissue glues (Histoacryl) mesh fixation Clinical effects were assessed by the following variables: intraoperative data, postoperative outcome as regard recurrence rate, postoperative complications, analgesic consumption, operation time, hospital stay, and patient costs. Follow up was 18 months.

Read the detailed description

Inguinal hernias are the commonest hernia met in clinical practice and accounts for 75% of abdominal hernia. Inguinal hernia repair is regarded as the standard treatment for adult symptomatic inguinal hernia following the international guideline for groin hernia management in which mesh is used to reinforce inguinal floor. Surgical mesh repair can be performed by open or laparoscopic techniques. Lichtenstein repair is commonly applied for open approach whereas trans-abdominal preperitoneal repair (TAPP) and totally extra peritoneal repair (TEP) are commonly used for laparoscopic approach.

During the repair of an inguinal hernia, sutures or tacks are generally used to secure the prosthetic mesh in place. In TAPP repairs the peritoneum is closed using sutures or tacks. These mesh fixation or peritoneal closure techniques may contribute to postoperative chronic pain presumably due to nerve irritation or entrapment .

Several techniques for mesh fixations have been used including suture, glue or self-gripping mesh for open hernia repair (OHR); metallic tack, absorbable tack, glue, suture, self-gripping mesh or even non-fixation techniques for laparoscopic hernia repair (LHR). Up to date, there have been eight systematic reviews and meta-analyses (SRMAs) on OHR (ie, glue vs suture (n=5) and self-gripping mesh vs suture (n=3) and one network meta-analysis (NMA For LHR, comparisons were tack and glue (n=6).

fixation versus no fixation (n=3) .Although evidences were interesting, the overall results were inconclusive. In mesh-based repair, flat mesh is recommended over three-dimension mesh, while self-gripping mesh is another alternative mesh..

Intraoperative strategies to reduce pain include the non-fixation of mesh or the use of non-mechanical methods of mesh fixation other than tacking or suturing, which may be less traumatic to the local tissue and less likely to cause local nerve entrapment. These non-mechanical methods include self-fixating meshes or glue. Similarly, closing the peritoneum with sutures may be less traumatic than the use of tacks, thus resulting in less postoperative pain .

Once positioned, meshes are designed to be integrated in local tissue by a fibrotic reaction that gradually incorporates them. Therefore, a good fixation is essential to secure the mesh in its correct position, while the integration process occurs. The introduction of synthetic meshes and their proper fixation has reduced recurrence rates to below 5%. As a consequence, the most frequent postoperative morbidities have become mesh migration, chronic pain, infection, and seroma .

Cyanoacrylic glues ensure high-degree and strong bonding to biologic tissues .When they get in contact with blood or water contained in the tissue, they form a very tight cover, binding to the surface within 5-6 s Overall, tacks provide excellent fixation strength, and they are also easy to apply. Nevertheless, their use is associated with significant morbidity. The penetration of the abdominal wall, in fact, may cause nerve and vessel entrapment. Also, tacks are themselves foreign bodies introduced in the abdomen, so they may cause inflammatory reactions. As a result, a significant number of patients suffer from pain and develop adhesion in the postoperative period. Moreover, cases of migration of titanium tacks have been described. At present, absorbable tacks are connected to lower inflammation rates, adhesion formation, and migration so the use of titanium tacks is no longer advisable

Aim of the work:

to determine whether there is any clinical or statistical difference in outcomes and morbidity when mesh is fixed or not during laparoscopic TAPP inguinal hernia repair. We will also compare different methods of mesh fixation (i.e.no fixation, tacks (non-absorbable and absorbable), and histoacryl) and techniques of peritoneal closure in TAPP repairs (tacks/sutures).

Patients \& Methods:

Our study is a randomized controlled clinical trial. It was conducted on sixty adult male patients presenting with oblique inguinal hernia admitted in general surgery department, faculty of medicine Zagazig university from June 2016 to June 2018.

All the patients in this study were performed under the same surgical team after fulfilling the consent of the operation and after acceptance of the faculty of medicine Zagazig ethical committee.

The patients were randomly divided into three groups Group (A): includes twenty patients: no mesh fixation. Group (B): includes twenty patients: fixation of the mesh by tacker Group C: includes twenty patients: fixation of mesh by histoacryl.

Types of outcome measures Primary outcomes: Hernia recurrence (clinical or radiological at any time point), Chronic pain: pain persisting beyond three months postoperatively and persisting numbness: numbness in the groin or testicle persisting beyond three months postoperatively Secondary outcomes: Length of surgery (in minutes), Immediate postoperative pain (visual analogue scale (VAS)/ pain score),Vascular/visceral injury at operation,Haematoma/seroma development in postoperative period, Length of hospital stay (in days),Urinary retention in immediate postoperative period, Wound infection/mesh infection at any time point and Recovery time to normal activity (in days)

Being tested
laparoscopic mesh fixation
Medical subject headings
Hernia, Inguinal

What participants receive

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

  • laparoscopic mesh fixationProcedure or surgery

    laparoscopic mesh fixation by non fixation,tacker and histoacryl

Study groups in NCT04272424
Study groupRoleWhat they receive
group AActive comparatorlaparoscopic hernioplasty with no fixation
Receives: Procedure: laparoscopic mesh fixation
group BActive comparatorlaparoscopic hernioplasty with tacker fixation
Receives: Procedure: laparoscopic mesh fixation
group CActive comparatorlaparoscopic hernioplasty with histoacryl fixation
Receives: Procedure: laparoscopic mesh fixation

What is being measured

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

  1. pain following lap hernioplasty with different method of fixation

    pain on visual analogue score

    Measured: 1.5 years

Secondary outcomes (1)
  1. recurrence of the disease following lap hernioplasty with different method of mesh fixation

    recurrent hernia

    Measured: 1.5 years

Timeline

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

  1. First posted17 Feb 2020
  2. Study start1 Jul 2016
  3. Primary completion1 Jul 2018
  4. Study completion1 Jul 2018

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
Single blind
Who is masked
Participant
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04272424
Sponsor's protocol ID
zagazig university 3
Status last verified
Sep 2022
First submitted
11 Feb 2020
Last updated
7 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing laparoscopic mesh fixation in people with Hernia, Inguinal, run by Zagazig University.

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 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 7 Sep 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. 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?

pain following lap hernioplasty with different method of fixation (time frame: 1.5 years). 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 7 Sep 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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