Clinical trial NCT05466084: Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.
Official title: A Randomized Controlled Trial Studying Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Keywords: Laparoscopic TAPP
tissue glue
tackers
hernia
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: postoperative pain
timeFrame: 6 weeks
Secondary outcomes:
measure: postoperative complications
timeFrame: 6 weeks
measure: operative time
timeFrame: intraoperative
measure: hospital stay
timeFrame: 6 WEEKS
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan , faculty of medicine
Study officials:
References: