NCT07196254

Brief Summary

Lumbar incisional hernia occurs after lumbar incision which is difficult to manage due deficient fascial aponeurosis and a proximity of the bonny boundaries, namely the iliac crest and the last rib. There is a need to evaluate sandwich mesh application, preperitoneal and onlay mesh, in the treatment of lumbar incisional hernia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

Same day

First QC Date

September 19, 2025

Last Update Submit

September 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • hernia recurrence rate detect by clinical examination and ultrasonography

    Hernia recurrence is the most critical measure of surgical failure and is a direct indicator of the long-term effectiveness of the repair. A lower recurrence rate demonstrates the superiority of one surgical technique or material over another.

    6 months starting from the postoperative day 1

Secondary Outcomes (1)

  • the rate of seroma formation as detected by subcutanous drain

    30 days from postoperative day 1

Study Arms (1)

hernia arm represent patients with lumbar abdominal hernia

EXPERIMENTAL

the patient that will undergo sandwich technique repair with onlay and sublay mesh

Procedure: sandwich mesh technique

Interventions

the hernia repair include using double mesh onlay and sublay

hernia arm represent patients with lumbar abdominal hernia

Eligibility Criteria

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

You may qualify if:

  • Patients older than 18 years old with primary inguinal hernia.

You may not qualify if:

  • Pregnancy or patients with bleeding tendency.
  • Complicated hernia.
  • Patients who are not fit for surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig Univeesity Hospitals

Zagazig, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

September 19, 2025

First Posted

September 29, 2025

Study Start

January 14, 2024

Primary Completion

January 14, 2024

Study Completion

January 14, 2024

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations