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Changing the Innate Consensus About Mesh Fixation in Trans-abdominal Preperitoneal Laparoscopic Inguinal Hernioplasty in Adults: Short and Long Term Outcome. Randomized Controlled Clinical Trial

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic mesh fixation
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ranging from 20 to 50
  • Both sex
  • An uncomplicated oblique inguinal hernia.
  • Unilateral hernia

Exclusion Criteria:

  • Patients younger than 20 or older than 50 year old
  • Patients with complicated hernia
  • Bilateral hernia
  • Recurrent hernia
  • Patients with previous lower abdominal surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    group A

    group B

    group C

    Arm Description

    laparoscopic hernioplasty with no fixation

    laparoscopic hernioplasty with tacker fixation

    laparoscopic hernioplasty with histoacryl fixation

    Outcomes

    Primary Outcome Measures

    pain following lap hernioplasty with different method of fixation
    pain on visual analogue score

    Secondary Outcome Measures

    recurrence of the disease following lap hernioplasty with different method of mesh fixation
    recurrent hernia

    Full Information

    First Posted
    February 11, 2020
    Last Updated
    September 5, 2022
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04272424
    Brief Title
    Changing the Innate Consensus About Mesh Fixation in Trans-abdominal Preperitoneal Laparoscopic Inguinal Hernioplasty in Adults: Short and Long Term Outcome. Randomized Controlled Clinical Trial
    Official Title
    Changing the Innate Consensus About Mesh Fixation in Trans-abdominal Preperitoneal Laparoscopic Inguinal Hernioplasty in Adults: Short and Long Term Outcome. Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    July 1, 2018 (Actual)
    Study Completion Date
    July 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig 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
    Introduction: Inguinal hernioplasty is the standard treatment for inguinal hernia. Mesh fixation is used to keep mesh in place for which various mesh fixation techniques have been used in laparoscopic inguinal hernia repair, but their effectiveness has remained inconclusive. Aim of the work: Randomized comparative study comparing early and late outcome of different method of mesh fixation. Methods: In Zagazig University Hospitals, over the period from July 2016 to July 2018, patients with with oblique inguinal hernias undergoing Tans abdominal preperitoneal technique were randomized into 3 groups: Group A; mesh non fixation . Group B; tacker mesh fixation Group C: Cyanoacrylic tissue glues (Histoacryl) mesh fixation Clinical effects were assessed by the following variables: intraoperative data, postoperative outcome as regard recurrence rate, postoperative complications, analgesic consumption, operation time, hospital stay, and patient costs. Follow up was 18 months.
    Detailed Description
    Inguinal hernias are the commonest hernia met in clinical practice and accounts for 75% of abdominal hernia. Inguinal hernia repair is regarded as the standard treatment for adult symptomatic inguinal hernia following the international guideline for groin hernia management in which mesh is used to reinforce inguinal floor. Surgical mesh repair can be performed by open or laparoscopic techniques. Lichtenstein repair is commonly applied for open approach whereas trans-abdominal preperitoneal repair (TAPP) and totally extra peritoneal repair (TEP) are commonly used for laparoscopic approach. During the repair of an inguinal hernia, sutures or tacks are generally used to secure the prosthetic mesh in place. In TAPP repairs the peritoneum is closed using sutures or tacks. These mesh fixation or peritoneal closure techniques may contribute to postoperative chronic pain presumably due to nerve irritation or entrapment . Several techniques for mesh fixations have been used including suture, glue or self-gripping mesh for open hernia repair (OHR); metallic tack, absorbable tack, glue, suture, self-gripping mesh or even non-fixation techniques for laparoscopic hernia repair (LHR). Up to date, there have been eight systematic reviews and meta-analyses (SRMAs) on OHR (ie, glue vs suture (n=5) and self-gripping mesh vs suture (n=3) and one network meta-analysis (NMA For LHR, comparisons were tack and glue (n=6). fixation versus no fixation (n=3) .Although evidences were interesting, the overall results were inconclusive. In mesh-based repair, flat mesh is recommended over three-dimension mesh, while self-gripping mesh is another alternative mesh.. Intraoperative strategies to reduce pain include the non-fixation of mesh or the use of non-mechanical methods of mesh fixation other than tacking or suturing, which may be less traumatic to the local tissue and less likely to cause local nerve entrapment. These non-mechanical methods include self-fixating meshes or glue. Similarly, closing the peritoneum with sutures may be less traumatic than the use of tacks, thus resulting in less postoperative pain . Once positioned, meshes are designed to be integrated in local tissue by a fibrotic reaction that gradually incorporates them. Therefore, a good fixation is essential to secure the mesh in its correct position, while the integration process occurs. The introduction of synthetic meshes and their proper fixation has reduced recurrence rates to below 5%. As a consequence, the most frequent postoperative morbidities have become mesh migration, chronic pain, infection, and seroma . Cyanoacrylic glues ensure high-degree and strong bonding to biologic tissues .When they get in contact with blood or water contained in the tissue, they form a very tight cover, binding to the surface within 5-6 s Overall, tacks provide excellent fixation strength, and they are also easy to apply. Nevertheless, their use is associated with significant morbidity. The penetration of the abdominal wall, in fact, may cause nerve and vessel entrapment. Also, tacks are themselves foreign bodies introduced in the abdomen, so they may cause inflammatory reactions. As a result, a significant number of patients suffer from pain and develop adhesion in the postoperative period. Moreover, cases of migration of titanium tacks have been described. At present, absorbable tacks are connected to lower inflammation rates, adhesion formation, and migration so the use of titanium tacks is no longer advisable Aim of the work: to determine whether there is any clinical or statistical difference in outcomes and morbidity when mesh is fixed or not during laparoscopic TAPP inguinal hernia repair. We will also compare different methods of mesh fixation (i.e.no fixation, tacks (non-absorbable and absorbable), and histoacryl) and techniques of peritoneal closure in TAPP repairs (tacks/sutures). Patients & Methods: Our study is a randomized controlled clinical trial. It was conducted on sixty adult male patients presenting with oblique inguinal hernia admitted in general surgery department, faculty of medicine Zagazig university from June 2016 to June 2018. All the patients in this study were performed under the same surgical team after fulfilling the consent of the operation and after acceptance of the faculty of medicine Zagazig ethical committee. The patients were randomly divided into three groups Group (A): includes twenty patients: no mesh fixation. Group (B): includes twenty patients: fixation of the mesh by tacker Group C: includes twenty patients: fixation of mesh by histoacryl. Types of outcome measures Primary outcomes: Hernia recurrence (clinical or radiological at any time point), Chronic pain: pain persisting beyond three months postoperatively and persisting numbness: numbness in the groin or testicle persisting beyond three months postoperatively Secondary outcomes: Length of surgery (in minutes), Immediate postoperative pain (visual analogue scale (VAS)/ pain score),Vascular/visceral injury at operation,Haematoma/seroma development in postoperative period, Length of hospital stay (in days),Urinary retention in immediate postoperative period, Wound infection/mesh infection at any time point and Recovery time to normal activity (in days)

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Active Comparator
    Arm Description
    laparoscopic hernioplasty with no fixation
    Arm Title
    group B
    Arm Type
    Active Comparator
    Arm Description
    laparoscopic hernioplasty with tacker fixation
    Arm Title
    group C
    Arm Type
    Active Comparator
    Arm Description
    laparoscopic hernioplasty with histoacryl fixation
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic mesh fixation
    Intervention Description
    laparoscopic mesh fixation by non fixation,tacker and histoacryl
    Primary Outcome Measure Information:
    Title
    pain following lap hernioplasty with different method of fixation
    Description
    pain on visual analogue score
    Time Frame
    1.5 years
    Secondary Outcome Measure Information:
    Title
    recurrence of the disease following lap hernioplasty with different method of mesh fixation
    Description
    recurrent hernia
    Time Frame
    1.5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ranging from 20 to 50 Both sex An uncomplicated oblique inguinal hernia. Unilateral hernia Exclusion Criteria: Patients younger than 20 or older than 50 year old Patients with complicated hernia Bilateral hernia Recurrent hernia Patients with previous lower abdominal surgery.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    tamer A. alnaimy, MD
    Organizational Affiliation
    Zagazig University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Changing the Innate Consensus About Mesh Fixation in Trans-abdominal Preperitoneal Laparoscopic Inguinal Hernioplasty in Adults: Short and Long Term Outcome. Randomized Controlled Clinical Trial

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