Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal (TAPP) Inguinal Hernia Repair Without Mesh Fixation, Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zagazig University
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- postoperative pain
Study Overview
Brief Summary
comparison between two groups of participants suffering inguinal hernia each group 23 individual all underwent laparoscopic trans-abdominal inguinal hernia repair first group received mesh fixation the second underwent no fixation , results of follow up in the first year were compared together
Detailed Description
This comparative study was performed in Zagazig university hospitals, general surgery department in the time period between july 2018 and june 2020 0n 46 patients undergoing laparoscopic trans abdominal preperitoneal (TAPP) repair for un complicated unilateral inguinal hernia.
Patient selection; In this study we enrolled patients above
- 18 years old suffering unilateral,
- non -recurrent,
- un-complicated inguinal hernia. We excluded patients with
- previous abdominal or pelvic surgery,
- unfit with laparoscopic surgery,
- those with ascites,
- abdominal malignancy
- on chemotherapy and immune-compromised patients.
Randomization; using computer generated random numbers , the study participants were randomly allocated into two equal groups each group 23 individual, the first group; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), and group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
All the study participants were subjected to thorough history taking, detailed clinical examination, determination of the presence of inguinal hernia, measurement of the hernia defect diameter by ultrasound or computerized tomography in difficult cases, preoperative laboratory tests were performed as per usual
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
the participants and the follow up surgeon don't know which received fixation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years old suffering unilateral,
- •non -recurrent,
- •un-complicated inguinal hernia.
Exclusion Criteria
- •previous abdominal or pelvic surgery,
- •unfit with laparoscopic surgery,
- •those with ascites,
- •abdominal malignancy
- •on chemotherapy and immune-compromised patients.
Arms & Interventions
fixation group
; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic),
Intervention: fixation of mesh prosthesis (Procedure)
non fixation group
group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
Intervention: mesh placement without fixation (Procedure)
Outcomes
Primary Outcomes
postoperative pain
Time Frame: 6 month
pain in the first 6 month of surgery measured by visual analogue scale
hernia recurrence
Time Frame: 1 year
recurrence of inguinal hernia measured by computed tomography of the abdomen
Secondary Outcomes
No secondary outcomes reported
Investigators
Hazem Nour Abdellatif
Assistant professor
Zagazig University