Clinical trial NCT06255314: Minimally Invasive Techniques in Ventral Hernioplasty
Official title: Evaluation of Minimally Invasive Ventral Hernioplasty With Extraperitoneal Mesh Placement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Operative time
timeFrame: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair.
measure: Intra operative injuries including bowel or vascular injuries
timeFrame: intra operative
Secondary outcomes:
measure: • Surgical site infection
timeFrame: postoperative up to 1month
measure: • Surgical site occurrence of hematoma ,seroma, necrosis
timeFrame: : 30 days
measure: • Hernia recurrence
timeFrame: : 1year
measure: Cost effectiveness
timeFrame: : 6months
measure: •Rate of mesh related complication such as bowel erosion
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine, Assiut University
Study officials:
References:
citation: LeBlanc KA, Booth WV. Laparoscopic repair of incisional abdominal hernias using expanded polytetrafluoroethylene: preliminary findings. Surg Laparosc Endosc. 1993 Feb;3(1):39-41.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.