Hernia
Conditions
Keywords
Laparoscopic TAPP, tissue glue, tackers, hernia
Brief summary
This is a randomized control trial intending to study the clinical difference between different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .
Detailed description
Laparoscopic transabdominal preperitoneal ( TAPP ) hernioplasty has emerged as an essential procedure for adults complaining of both unilateral and bilateral inguinal hernia , various descriptions of the procedure have been published recently, complications and recurrence rates are being calculated for each method, different mesh fixation techniques are being used by different surgeons, some use surgical tackers, some use fibrin glue and some demonstrated an equal outcome if the mesh was not fixed at all. This is a randomized control trial intending to study the clinical difference between those different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .
Interventions
PROCEDUREtissue Glue for mesh fixation
one arm of the study had their mesh fixed with tissue glue applied at multiple sites
PROCEDUREMetallic Tackers for mesh fixation
in the other arm mesh was fixed with tackers applied avoiding the triangle of pain and the triangle of doom using a three point fixation technique; Cooper's ligament, medial cranial edge of the mesh and just lateral to the inferior epigastric vessels.
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* all Adult Patients ages between 18 and 80 years old, males and females, inguinal hernias, unilateral or bilateral and femoral hernias.
Exclusion criteria
* operations which were converted from TAPP to other procedures (such as open repair or TEP). * Patients who were unfit for general anesthesia * patients who refused to participate in the study * patients with chronic pain disorders requiring long term pain management before the procedure. * cases with complicated hernias that required emergency repair.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | 6 weeks | postoperative pain was measured using The visual analog scale ( VAS ) scored from 1-10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complications | 6 weeks | postoperative complications including : seroma, ssi , hematoma and others |
| operative time | intraoperative | operative time |
| hospital stay | 6 WEEKS | postoperative days in hospital measured |
Countries
Jordan
Outcome results
None listed