NCT06255314

Brief Summary

  1. 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. 2.Reviewing advantages and drawbacks of each surgical technique regarding feasibility ,cost effectiveness and technical difficulties

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress85%
Feb 2024Oct 2026

First Submitted

Initial submission to the registry

January 20, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 13, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

January 20, 2024

Last Update Submit

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

EXPERIMENTAL
Procedure: ventral hernia repair

enhanced view totally extraperitoneal laparoscopic ventral hernia repair

EXPERIMENTAL
Procedure: ventral hernia repair

open sublay ventral hernia repair

EXPERIMENTAL
Procedure: ventral hernia repair

Interventions

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

enhanced view totally extraperitoneal laparoscopic ventral hernia repairopen sublay ventral hernia repairtrans abdominal retromusclar laparoscopic ventral hernia repar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 8258069BACKGROUND
  • 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.

    PMID: 23095614BACKGROUND
  • 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.

    PMID: 18790156BACKGROUND
  • 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.

    PMID: 28025740BACKGROUND
  • 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.

    PMID: 26983436BACKGROUND
  • 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.

    PMID: 26246228BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

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

Locations