NCT06149858

Brief 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)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

November 10, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

November 10, 2023

Last Update Submit

November 26, 2023

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

  • recurrence rate

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

    baseline

Study Arms (2)

sublay

EXPERIMENTAL

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

Procedure: hernioplasty

laparoscopic

EXPERIMENTAL

patients with ventral hernia operated as laparoscopic repair positioning TAPP mesh

Procedure: hernioplasty

Interventions

hernioplastyPROCEDURE

ventral hernia repair with mesh

laparoscopicsublay

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All cases of midline ventral hernia fit for surgery

You may not qualify if:

  • Surgically unfit cases
  • Complicated hernia (obstructed ,irreducible, strangulated)
  • incisional ,massive ,recurrent hernias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 35103166BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Officials

  • hisham ryad

    STUDY DIRECTOR

Central Study Contacts

ahmed hussein

CONTACT

01091081032ahmed.nazeir.1996@gmail.com

Ibrahim Mostafa

CONTACT

01090526849Ibrahim.mostafa@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 29, 2023

Study Start

December 1, 2023

Primary Completion

December 30, 2025

Study Completion

March 1, 2026

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share