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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
Sponsor:
Information provided by (Responsible Party):
Mohamad Hamdy, Assiut University

Study Description
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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


Condition or disease Intervention/treatment Phase
Inguinal Hernia Procedure: Trans-inguinal Pre-peritoneal Hernioplasty Procedure: Lichtnestein's hernioplasty Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. recurrence rate [ Time Frame: 6 to 12 month post operative ]
    comparison between the two techniques concerning recurrence rate of inguinal hernia

  4. operation time [ Time Frame: intra-operative ]
    comparison between the two techniques regarding operative time

  5. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
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Contact: mohamad hamdy, MBBS 01028086209 mohamdy.mh@gmail.com
Contact: faculty of medicine - assiut university faculty of medicine - assiut university

Sponsors and Collaborators
Assiut University
More Information
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Additional Information:

Publications:

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Responsible Party: Mohamad Hamdy, Resident doctor at General surgery department, Assiut University
ClinicalTrials.gov Identifier: NCT03438786    
Other Study ID Numbers: inguinal hernia
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical examination will be undertaken immediately post-operative looking for any wound complication or scrotal collection .

Clinical examination will be undertaken at 1 , 3 ,6 months post-operative looking for :-

  • Wound complication
  • Scrotal collection
  • Chronic Pain
  • Recurrence

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal