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Minimally Invasive Techniques in Ventral Hernioplasty

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ClinicalTrials.gov Identifier: NCT06255314
Recruitment Status : Not yet recruiting
First Posted : February 13, 2024
Last Update Posted : February 13, 2024
Sponsor:
Information provided by (Responsible Party):
Mohamed Ashraf Mohamed Badr, Assiut University

Study Description
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Brief Summary:
  1. Review the surgical outcome of different techniques using extraperitoneal ventral hernia repair regarding postoperative pain. wound infection ,hospital stay , recurrence ,mesh migration and mesh induced visceral complications.
  2. Reviewing advantages and drawbacks of each surgical technique regarding feasibility ,cost effectiveness and technical difficulties

Condition or disease Intervention/treatment Phase
Ventral Hernia Procedure: ventral hernia repair Not Applicable

Detailed Description:
The laparoscopic ventral hernia repair was first introduced by LeBlanc and Booth in the early 1990s . Since its introduction, it has continued to evolve and has become an important option in the hernia surgeon's armamentarium. However, only 27.4% of ventral hernia repairs are performed laparoscopically, likely because of the relatively advanced nature of this procedure and because all hernias may not be suitable for a laparoscopic approach. Using current techniques, numerous studies have documented the safety and efficacy of this approach. Some data suggest that the laparoscopic approach results in a shorter hospital stay and lower recurrence rates compared with open approaches. However, pain may still be significant after laparoscopic repairs and there are not significant advantages from this standpoint. Nonetheless, it is well accepted that the primary advantage of the laparoscopic approach is that wound infections are less frequent compared with open approaches .LeBlanc and Booth in 1993 first reported application of intra-peritoneal onlay mesh (IPOM) for ventral and incisional hernia, However the technique requires expensive fixation devices which may cause acute and chronic pain .The laparoscopic groin hernia repair using synthetic mesh in TEP or TAPP are acceptable surgical techniques today These techniques are rarely associated with mesh induced complications, the reason being extraperitoneal placement of synthetic mesh. It is apparent that despite great progress in mesh technology, nearly all types of meshes have been found to produce a varying level of adhesion or tissue reaction, regardless of the material and coating used. Preoperatively unpredictable, a mesh-induced visceral complication may occur in some patients to produce severe reaction or major mesh-related adverse events.The incitation to develop certain novel minimally invasive techniques that enables researchers to bring the mesh out of abdominal cavity has been an exciting trend in laparoscopic hernia repair.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Minimally Invasive Ventral Hernioplasty With Extraperitoneal Mesh Placement
Estimated Study Start Date : February 2024
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: trans abdominal retromusclar laparoscopic ventral hernia repar Procedure: ventral hernia repair

Laparoscopic transabdominal retromuscular repair is a minimally invasive approach to the open Rives Stoppa retromuscular sublay repair for ventral hernia.

In ventral hernia repair, it relies on initiation of dissection in one retrorectus space and then crossover to the contralateral retrorectus space The sublay mesh technique is an open surgical procedure for ventral and incisional hernias
Experimental: enhanced view totally extraperitoneal laparoscopic ventral hernia repair Procedure: ventral hernia repair

Laparoscopic transabdominal retromuscular repair is a minimally invasive approach to the open Rives Stoppa retromuscular sublay repair for ventral hernia.

In ventral hernia repair, it relies on initiation of dissection in one retrorectus space and then crossover to the contralateral retrorectus space The sublay mesh technique is an open surgical procedure for ventral and incisional hernias
Experimental: open sublay ventral hernia repair Procedure: ventral hernia repair

Laparoscopic transabdominal retromuscular repair is a minimally invasive approach to the open Rives Stoppa retromuscular sublay repair for ventral hernia.

In ventral hernia repair, it relies on initiation of dissection in one retrorectus space and then crossover to the contralateral retrorectus space The sublay mesh technique is an open surgical procedure for ventral and incisional hernias


Outcome Measures
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Primary Outcome Measures :
  1. Operative time [ Time Frame: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair. ]
  2. Intra operative injuries including bowel or vascular injuries [ Time Frame: intra operative ]

Secondary Outcome Measures :
  1. • Surgical site infection [ Time Frame: postoperative up to 1month ]
  2. • Surgical site occurrence of hematoma ,seroma, necrosis [ Time Frame: : 30 days ]
  3. • Hernia recurrence [ Time Frame: : 1year ]
  4. Cost effectiveness [ Time Frame: : 6months ]
    cost of polyprolene mesh compared to composite mesh by egyptian pound

  5. •Rate of mesh related complication such as bowel erosion [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Able to give informed consent for inclusion in the study

    • Age of the patient : above 18 years
    • Any type of ventral hernia including umbilical,paraumbilical,epigastric,spigelian and incisional hernias

Exclusion Criteria:

  • • Patients with inguinal hernia.

    • Strangulated or obstructed hernia.
    • Previous mesh hernia repair.
    • Loss of abdominal domain.
    • Infected or contaminated field.
    • Defect size more than 10cm.
Contacts and Locations
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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): NCT06255314


Contacts
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Contact: mohamed badr 01060624371 akhel93@yahoo.com
Contact: samir ammar, MD 01141459567 samirahmed22@aun.edu.eg

Locations
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Egypt
Faculty of medicine, Assiut University
Assiut, Egypt, 71515
Contact: samir ammar, MD    01141459567    samirahmed22@aun.edu.eg   
Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Mohamed Ashraf Mohamed Badr, teaching assistant, Assiut University
ClinicalTrials.gov Identifier: NCT06255314    
Other Study ID Numbers: laparoscopic ventral hernia
First Posted: February 13, 2024    Key Record Dates
Last Update Posted: February 13, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Ventral
Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal