Minimally Invasive Techniques in Ventral Hernioplasty

Evaluation of Minimally Invasive Ventral Hernioplasty With Extraperitoneal Mesh Placement

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ventral Hernia
• Intervention / Treatment: Procedure: ventral hernia repair

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohamed badr; Phone Number: 01060624371; Email: akhel93@yahoo.com
• Study Contact Backup: Name: samir ammar, MD; Phone Number: 01141459567; Email: samirahmed22@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Faculty of Medicine, Assiut University
    • Contact: samir ammar, MD; Phone Number: 01141459567; Email: samirahmed22@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• LeBlanc KA, Booth WV. Laparoscopic repair of incisional abdominal hernias using expanded polytetrafluoroethylene: preliminary findings. Surg Laparosc Endosc. 1993 Feb;3(1):39-41.
• Colavita PD, Tsirline VB, Belyansky I, Walters AL, Lincourt AE, Sing RF, Heniford BT. Prospective, long-term comparison of quality of life in laparoscopic versus open ventral hernia repair. Ann Surg. 2012 Nov;256(5):714-22; discussion 722-3. doi: 10.1097/SLA.0b013e3182734130.
• Jin J, Rosen MJ. Laparoscopic versus open ventral hernia repair. Surg Clin North Am. 2008 Oct;88(5):1083-100, viii. doi: 10.1016/j.suc.2008.05.015.
• Golani S, Middleton P. Long-term follow-up of laparoscopic total extraperitoneal (TEP) repair in inguinal hernia without mesh fixation. Hernia. 2017 Feb;21(1):37-43. doi: 10.1007/s10029-016-1558-7. Epub 2016 Dec 26.
• Muschalla F, Schwarz J, Bittner R. Effectivity of laparoscopic inguinal hernia repair (TAPP) in daily clinical practice: early and long-term result. Surg Endosc. 2016 Nov;30(11):4985-4994. doi: 10.1007/s00464-016-4843-8. Epub 2016 Mar 16.
• Tung KLM, Cheung HYS, Tang CN. Non-healing enterocutaneous fistula caused by mesh migration. ANZ J Surg. 2018 Jan;88(1-2):E73-E74. doi: 10.1111/ans.13253. Epub 2015 Aug 5. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 20, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: laparoscopic ventral hernia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No