Clinical trial NCT03438786: Trans-inguinal Pre-peritoneal Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair
Official title: Trans-inguinal Pre-peritoneal (TIPP) Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. Patients who were unfit for operation.
2. Patients with bilateral or recurrent inguinal hernia
3. Patients aged below 18 years,
4. Patients undergoing emergency hernia repairs

Eligibility criteria: Inclusion Criteria:

* . Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH

Exclusion Criteria:

1. Patients who were unfit for operation.
2. Patients with bilateral or recurrent inguinal hernia
3. Patients aged below 18 years,
4. Patients undergoing emergency hernia repairs

Primary outcomes:
measure: comparison between the 2 techniques regarding presence and duration of post-operative chronic pain
timeFrame: visits will be within 6 months post operative
Secondary outcomes:
measure: Duration of hospital stay post operative
timeFrame: first week post operative
measure: presence of any wound complication by examining the wound
timeFrame: first 2 weeks post operative
measure: recurrence rate
timeFrame: 6 to 12 month post operative
measure: operation time
timeFrame: intra-operative
measure: time needed for the patient to return to work
timeFrame: 1 month post operative
Other outcomes:
Locations:
Study officials:
References:
citation: Cheek CM, Black NA, Devlin HB, Kingsnorth AN, Taylor RS, Watkin DF. Groin hernia surgery: a systematic review. Ann R Coll Surg Engl. 1998;80 Suppl 1:S1-80.
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citation: Vironen J, Nieminen J, Eklund A, Paavolainen P. Randomized clinical trial of Lichtenstein patch or Prolene Hernia System for inguinal hernia repair. Br J Surg. 2006 Jan;93(1):33-9. doi: 10.1002/bjs.5235.
citation: Gilbert AI, Felton LL. Infection in inguinal hernia repair considering biomaterials and antibiotics. Surg Gynecol Obstet. 1993 Aug;177(2):126-30.
citation: Awad SS, Fagan SP. Current approaches to inguinal hernia repair. Am J Surg. 2004 Dec;188(6A Suppl):9S-16S. doi: 10.1016/j.amjsurg.2004.09.007.
citation: Chung L, Norrie J, O'Dwyer PJ. Long-term follow-up of patients with a painless inguinal hernia from a randomized clinical trial. Br J Surg. 2011 Apr;98(4):596-9. doi: 10.1002/bjs.7355. Epub 2010 Nov 30.
citation: Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009 Aug;13(4):343-403. doi: 10.1007/s10029-009-0529-7. Epub 2009 Jul 28.