Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04272424 |
| Other study ID # |
zagazig university 3 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2016 |
| Est. completion date |
July 1, 2018 |
Study information
| Verified date |
September 2022 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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)
