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

Primary Purpose

Inguinal Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Trans-inguinal Pre-peritoneal Hernioplasty
Lichtnestein's hernioplasty
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    group A

    group B

    Arm Description

    Patients undergoing trans-inguinal pre-peritoneal (TIPP) hernioplasty

    Patients undergoing lichtnestein's hernioplasty

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Duration of hospital stay 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
    comparison between the two techniques concerning presence of any wound complications by wound examination
    recurrence rate
    comparison between the two techniques concerning recurrence rate of inguinal hernia
    operation time
    comparison between the two techniques regarding operative time
    time needed for the patient to return to work
    comparison between the two techniques regarding needed time to return to work

    Full Information

    First Posted
    January 23, 2018
    Last Updated
    February 17, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03438786
    Brief Title
    Trans-inguinal Pre-peritoneal Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair
    Acronym
    TIPP
    Official Title
    Trans-inguinal Pre-peritoneal (TIPP) Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    June 1, 2020 (Anticipated)
    Study Completion Date
    June 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inguinal Hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Experimental
    Arm Description
    Patients undergoing trans-inguinal pre-peritoneal (TIPP) hernioplasty
    Arm Title
    group B
    Arm Type
    Experimental
    Arm Description
    Patients undergoing lichtnestein's hernioplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    Trans-inguinal Pre-peritoneal Hernioplasty
    Other Intervention Name(s)
    TIPP Technique
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Lichtnestein's hernioplasty
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    comparison between the 2 techniques regarding presence and duration of post-operative chronic pain
    Description
    post operative clinical examination for assessment of the presence and duration of chronic pain
    Time Frame
    visits will be within 6 months post operative
    Secondary Outcome Measure Information:
    Title
    Duration of hospital stay post operative
    Description
    comparison between the two techniques concerning Duration of hospital stay post operation after each procedure
    Time Frame
    first week post operative
    Title
    presence of any wound complication by examining the wound
    Description
    comparison between the two techniques concerning presence of any wound complications by wound examination
    Time Frame
    first 2 weeks post operative
    Title
    recurrence rate
    Description
    comparison between the two techniques concerning recurrence rate of inguinal hernia
    Time Frame
    6 to 12 month post operative
    Title
    operation time
    Description
    comparison between the two techniques regarding operative time
    Time Frame
    intra-operative
    Title
    time needed for the patient to return to work
    Description
    comparison between the two techniques regarding needed time to return to work
    Time Frame
    1 month post operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohamad hamdy, MBBS
    Phone
    01028086209
    Email
    mohamdy.mh@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    faculty of medicine - assiut university faculty of medicine - assiut university

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing 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
    Citations:
    PubMed Identifier
    11432408
    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.
    Results Reference
    background
    PubMed Identifier
    14735339
    Citation
    Heikkinen T, Bringman S, Ohtonen P, Kunelius P, Haukipuro K, Hulkko A. Five-year outcome of laparoscopic and Lichtenstein hernioplasties. Surg Endosc. 2004 Mar;18(3):518-22. doi: 10.1007/s00464-003-9119-4. Epub 2004 Jan 23.
    Results Reference
    background
    PubMed Identifier
    16329082
    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.
    Results Reference
    background
    PubMed Identifier
    8251018
    Citation
    Gilbert AI, Felton LL. Infection in inguinal hernia repair considering biomaterials and antibiotics. Surg Gynecol Obstet. 1993 Aug;177(2):126-30. Erratum In: Surg Gynecol Obstet 1993 Nov;177(5):528.
    Results Reference
    background
    PubMed Identifier
    15610887
    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.
    Results Reference
    background
    PubMed Identifier
    21656724
    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.
    Results Reference
    background
    PubMed Identifier
    19636493
    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.
    Results Reference
    background
    Links:
    URL
    https://emedicine.medscape.com/article/1534281-overview
    Description
    Related Info
    URL
    https://emedicine.medscape.com/article/1534281-technique#c2
    Description
    Related Info

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

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