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NCT Number: NCT06255314

Minimally Invasive Techniques in Ventral Hernioplasty

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ventral Hernia Repair

Procedure

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

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

mohamed badr

CONTACT

[email protected]

01060624371

samir ammar, MD

CONTACT

[email protected]

01141459567

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Evaluation of Minimally Invasive Ventral Hernioplasty With Extraperitoneal Mesh Placement

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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