A Randomized Controlled Trial Studying Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Jordan
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- postoperative pain
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
tissue glue
mesh fixed using tissue glue
Intervention: tissue Glue for mesh fixation (Procedure)
metallic tackers
mesh fixed using metallic tackers
Intervention: Metallic Tackers for mesh fixation (Procedure)
Outcomes
Primary Outcomes
postoperative pain
Time Frame: 6 weeks
postoperative pain was measured using The visual analog scale ( VAS ) scored from 1-10
Secondary Outcomes
- hospital stay(6 WEEKS)
- postoperative complications(6 weeks)
- operative time(intraoperative)
Investigators
Hanan Ibrahim Mansour
General surgery specialist
University of Jordan