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
About this trial
This is an interventional treatment trial for Hernia, Inguinal
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.
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
NCT ID
NCT04272424
First Posted
February 11, 2020
Last Updated
September 5, 2022
Sponsor
Zagazig University
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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