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Clinical Trials/NCT03438786
NCT03438786
Unknown
Not Applicable

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

Assiut University0 sites30 target enrollmentMarch 2018
ConditionsInguinal Hernia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inguinal Hernia
Sponsor
Assiut University
Enrollment
30
Primary Endpoint
comparison between the 2 techniques regarding presence and duration of post-operative chronic pain
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 2018
End Date
June 30, 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamad Hamdy

Resident doctor at General surgery department

Assiut University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • operation time(intra-operative)
  • Duration of hospital stay post operative(first week post operative)
  • presence of any wound complication by examining the wound(first 2 weeks post operative)
  • recurrence rate(6 to 12 month post operative)
  • time needed for the patient to return to work(1 month post operative)

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