Trans-inguinal Pre-peritoneal Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair

Study Overview
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Brief Summary
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Mesh repair of inguinal hernia is the most common operation performed on general surgical patients. Approximately 20 million groin hernioplasties are performed each year worldwide. Countless studies have been reported in the medical literature in attempts to improve the overall outcomes following hernia operations and, due to this fact, the procedure has evolved immensely, especially over the last few decades. Recurrence of inguinal hernia was initially a significant problem. Lichtenstein repair (LR), recurrence rate has consistently been reported as low as 1-4%[2], a drop from up to 10%. But increased incidence of chronic groin pain following LR. Transinguinal preperitoneal (TIPP) inguinal hernia repair with soft mesh has been reported as a safe anterior approach with a preperitoneal mesh position . Theoretically, TIPP repair may be associated with lesser chronic postoperative pain than Lichtenstein's technique due to the placement of mesh in the preperitoneal space to avoid direct regional nerves dissection and their exposure to bio-reactive synthetic mesh. The placement of mesh in this plane without using any suture for fixation and lack of mesh exposure to regional nerves was assumed to result in the reduced risk of developing chronic groin pain. So aim of our study to prove less hospital stay and complication and cost effectiveness for preperitoneal meshplasty

Detailed Description
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This study is a prospective randomized study including all Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH during the period from 3- 2018 to 6- 2020 Methodology: Patients will be classified into two groups according to the surgical procedure performed as follows: Group A: Patients undergoing TIPP hernioplasty Group B: Patients undergoing lichtnestein's technique hernioplasty Sample size:15 patients for each group. D) Exclusion criteria: Patients who were unfit for operation. Patients with bilateral or recurrent inguinal hernia Patients aged below 18 years, Patients undergoing emergency hernia repairs

Official Title
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Trans-inguinal Pre-peritoneal (TIPP) Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Trans-inguinal Pre-peritoneal Hernioplasty
* Procedure: Lichtnestein's hernioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: . Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH Exclusion Criteria: Patients who were unfit for operation. Patients with bilateral or recurrent inguinal hernia Patients aged below 18 years, Patients undergoing emergency hernia repairs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients will be randomized into two groups according to the surgical technique performed as follows :- Group A: Patients undergoing TIPP hernioplasty Group B: Patients undergoing lichtnestein's technique hernioplasty
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>Patients undergoing trans-inguinal pre-peritoneal (TIPP) hernioplasty | Procedure: Trans-inguinal Pre-peritoneal Hernioplasty<br>* patients were catheterised pre-operatively, to prevent any injury to the bladder and aid in preperitoneal dissection. The catheter was removed after 48 hours post-operatively. Incision of TIPP is same as that of Lichtenstein technique . After dissection of the sac, the transversalis is fascia is incised to enter the preperitoneal space. The preperitoneal space is developed by dissection with index finger. The space extends from rectus muscle medially, arcuate line cranially, a little beyond the anterior superior iliac spine over the psoas muscle laterally and the lilipubic tract caudally. A 15 cm x 15 cm polypropylene mesh, cut into dimension 15 cm x 12 cm, the inferior medial angle of the mesh is trimmed in a semicircular fashion to prevent trauma to the bladder neck. The mesh is placed in the preperitoneal space and anchored to the Cooper's ligament with a single 2-0 interrupted prolene suture<br>* Other names: TIPP Technique;|
| Experimental: group B<br>Patients undergoing lichtnestein's hernioplasty | Procedure: Lichtnestein's hernioplasty<br>* incision 1 cm above and parallel to inguinal ligament,Opening subcutaneous fat ,Opening Scarpa fascia to external oblique aponeurosis ,visualization of external ring and lower border of the inguinal ligament,Opening deep fascia of the thigh,checking for a femoral hernia ,Division of external oblique aponeurosis from external ring laterally for 5 cm, safeguarding ilioinguinal nerve ,Mobilization of superior and inferior flaps of external oblique aponeurosis exposing underlying structures ,Mobilization of spermatic cord along with the cremaster, including (ilioinguinal ,genitofemoral) nerves, and spermatic vessels; all of these structures may be encircled in a tape ,Opening of the coverings of spermatic cord, identification and isolation of the hernia sac ,Inversion, division, resection, or ligation of the sac ,Placement and fixation of mesh to edges of the defect or weakness in the posterior wall of inguinal canal creating artificial internal ring,Closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison between the 2 techniques regarding presence and duration of post-operative chronic pain | post operative clinical examination for assessment of the presence and duration of chronic pain | visits will be within 6 months post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay post operative | comparison between the two techniques concerning Duration of hospital stay post operation after each procedure | first week post operative | 
| presence of any wound complication by examining the wound | comparison between the two techniques concerning presence of any wound complications by wound examination | first 2 weeks post operative | 
| recurrence rate | comparison between the two techniques concerning recurrence rate of inguinal hernia | 6 to 12 month post operative | 
| operation time | comparison between the two techniques regarding operative time | intra-operative | 
| time needed for the patient to return to work | comparison between the two techniques regarding needed time to return to work | 1 month post operative |