Minimally Invasive Techniques in Ventral Hernioplasty

Not Applicable

Not yet recruiting

• Conditions: Ventral Hernia
• Interventions: Procedure: ventral hernia repair

• Registration Number: NCT06255314
• Lead Sponsor: Assiut University

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

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 Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-20
• Study Start: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enhanced view totally extraperitoneal laparoscopic ventral hernia repair	ventral hernia repair	-
trans abdominal retromusclar laparoscopic ventral hernia repar	ventral hernia repair	-
open sublay ventral hernia repair	ventral hernia repair	-

Primary Outcome Measures

Name	Time	Method
Operative time	from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair.
Intra operative injuries including bowel or vascular injuries	intra operative

Secondary Outcome Measures

Name	Time	Method
• Surgical site occurrence of hematoma ,seroma, necrosis	: 30 days
• Surgical site infection	postoperative up to 1month
• Hernia recurrence	: 1year
Cost effectiveness	: 6months	cost of polyprolene mesh compared to composite mesh by egyptian pound
•Rate of mesh related complication such as bowel erosion	1 year

Trial Locations

Locations (1)

Faculty of medicine, Assiut University; 🇪🇬 Assiut, Egypt