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Not yet recruitingNCT06149858Updated Nov 29, 2023

Ventral Mesh Hernioplasty : Laparoscopic Versus Open Sublay

An interventional study of hernioplasty in Ventral Hernia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To compare between laparoscopic ventral hernia repair and open sublay technique (recurrence ,operative time ,bleeding ,rate of complication and injury , seroma, post operative pain)

Read the detailed description

A hernia usually happens in abdomen or groin, when one of your organs pushes through the muscle or tissue that contains it. Most hernias eventually will need surgical repair.

sublay mesh repair has the lowest recurrence and surgical site infection in open anterior abdominal hernia repair it is a perfect choice for the repair of ventral abdominal hernia the principles included two main steps: (1) mesh placement deep into the recti muscles and (2) mesh extension beyond the hernia defect.

Laparoscopic ventral hernia repair (LVHR) has established itself as a well-accepted option in the treatment of hernias. Clear benefits have been established regarding the superiority of LVHR in terms of fewer wound infections compared with open repairs. Meticulous technique and appropriate patient selection are critical to obtain the reported results.

  • In the laparoscopic technique, a prosthetic mesh is inserted through a trocar into the abdominal cavity and fixed against the abdominal wall. After reducing the hernia contents, the hernia sac is left unresected, and most surgeons do not place additional sutures for closing the hernia orifice. A specific risk of laparoscopic hernia repair lies in freeing adhesions between intestine and abdominal wall, which may result in (sometimes unrecognised) bowel perforation . The mesh should overlap the hernia orifice by at least 5 cm and is anchored to the abdominal wall with tacks, transfascial sutures, or a combination of the two methods. In laparoscopic abdominal hernia repair, mesh placement methods are generally classified into intraperitoneal onlay mesh (IPOM), transabdominal abdominal preperitoneal (TAPP)
02

Conditions studied

  • Ventral Hernia

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03

In context

Hernia, Ventral

230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 153 interventional studies indexed under Hernia, Ventral.

Browse Hernia, Ventral studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All cases of midline ventral hernia fit for surgery

Exclusion criteria

Exclusion Criteria:

  1. Surgically unfit cases
  2. Complicated hernia (obstructed ,irreducible, strangulated)
  3. incisional ,massive ,recurrent hernias
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    sublay

    patients with ventral hernia operated as sublay mesh repair positioning of mesh under sheath

    Procedure: hernioplasty

  • Experimental
    laparoscopic

    patients with ventral hernia operated as laparoscopic repair positioning TAPP mesh

    Procedure: hernioplasty

Interventions

  • Procedurehernioplasty

    ventral hernia repair with mesh

06

What researchers measure

Primary outcomes

  1. recurrence rate

    compare between laparoscopic ventral hernia repair and open sublay technique in how long the hernia take to occur again

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Issa M, Noureldin K, Elgadi A, Abdelaziz A, Badawi M, Makram M. Evaluation of the Sublay Mesh Repair Outcomes in Different Types of Ventral Hernia. Cureus. 2021 Dec 21;13(12):e20590. doi: 10.7759/cureus.20590. eCollection 2021 Dec. PubMed 35103166 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06149858
Lead sponsor
Assiut University
Responsible party
ahmed hussein abozeid ahmed (resident doctor, Assiut University) — Principal investigator
First posted
Nov 29, 2023
Start date
Dec 1, 2023 (estimated)
Primary completion
Dec 30, 2025 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Nov 29, 2023

Study contacts

ahmed hussein
Contact
ahmed.nazeir.1996@gmail.com
01091081032
Ibrahim Mostafa
Contact
Ibrahim.mostafa@aun.edu.eg
01090526849
hisham ryad
study director

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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