Trans-inguinal Pre-peritoneal Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair (TIPP)
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|ClinicalTrials.gov Identifier: NCT03438786|
Recruitment Status : Unknown
Verified February 2018 by Mohamad Hamdy, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : February 20, 2018
Last Update Posted : February 20, 2018
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%, 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
|Condition or disease||Intervention/treatment||Phase|
|Inguinal Hernia||Procedure: Trans-inguinal Pre-peritoneal Hernioplasty Procedure: Lichtnestein's hernioplasty||Not Applicable|
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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
patients will be randomized into two groups according to the surgical technique performed as follows :-
|Official Title:||Trans-inguinal Pre-peritoneal (TIPP) Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair|
|Estimated Study Start Date :||March 2018|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: group A
Patients undergoing trans-inguinal pre-peritoneal (TIPP) hernioplasty
Procedure: Trans-inguinal Pre-peritoneal Hernioplasty
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
Other Name: TIPP Technique
Experimental: group B
Patients undergoing lichtnestein's hernioplasty
Procedure: Lichtnestein's hernioplasty
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
- comparison between the 2 techniques regarding presence and duration of post-operative chronic pain [ Time Frame: visits will be within 6 months post operative ]post operative clinical examination for assessment of the presence and duration of chronic pain
- Duration of hospital stay post operative [ Time Frame: first week post operative ]comparison between the two techniques concerning Duration of hospital stay post operation after each procedure
- presence of any wound complication by examining the wound [ Time Frame: first 2 weeks post operative ]comparison between the two techniques concerning presence of any wound complications by wound examination
- recurrence rate [ Time Frame: 6 to 12 month post operative ]comparison between the two techniques concerning recurrence rate of inguinal hernia
- operation time [ Time Frame: intra-operative ]comparison between the two techniques regarding operative time
- time needed for the patient to return to work [ Time Frame: 1 month post operative ]comparison between the two techniques regarding needed time to return to work
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438786
|Contact: mohamad hamdy, MBBSemail@example.com|
|Contact: faculty of medicine - assiut university faculty of medicine - assiut university|