Minimally Invasive Techniques in Ventral Hernioplasty
Evaluation of Minimally Invasive Ventral Hernioplasty With Extraperitoneal Mesh Placement
1 other identifier
interventional
45
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2024
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedFirst Posted
Study publicly available on registry
February 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
February 13, 2024
January 1, 2024
2.7 years
January 20, 2024
February 2, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
• Surgical site infection
postoperative up to 1month
• Surgical site occurrence of hematoma ,seroma, necrosis
: 30 days
• Hernia recurrence
: 1year
Cost effectiveness
: 6months
•Rate of mesh related complication such as bowel erosion
1 year
Study Arms (3)
trans abdominal retromusclar laparoscopic ventral hernia repar
EXPERIMENTALenhanced view totally extraperitoneal laparoscopic ventral hernia repair
EXPERIMENTALopen sublay ventral hernia repair
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Age of the patient : above 18 years
- Any type of ventral hernia including umbilical,paraumbilical,epigastric,spigelian and incisional hernias
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of medicine, Assiut University
Asyut, 71515, Egypt
Related Publications (6)
LeBlanc KA, Booth WV. Laparoscopic repair of incisional abdominal hernias using expanded polytetrafluoroethylene: preliminary findings. Surg Laparosc Endosc. 1993 Feb;3(1):39-41.
PMID: 8258069BACKGROUNDColavita 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.
PMID: 23095614BACKGROUNDJin 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.
PMID: 18790156BACKGROUNDGolani 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.
PMID: 28025740BACKGROUNDMuschalla 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.
PMID: 26983436BACKGROUNDTung 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.
PMID: 26246228BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- teaching assistant
Study Record Dates
First Submitted
January 20, 2024
First Posted
February 13, 2024
Study Start
February 1, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
February 13, 2024
Record last verified: 2024-01