Ventral Mesh Hernioplasty : Laparoscopic Versus Open Sublay

NCT ID: NCT06149858

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-03-01

Brief Summary

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

Detailed Description

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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)

Conditions

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Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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sublay

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

Group Type EXPERIMENTAL

hernioplasty

Intervention Type PROCEDURE

ventral hernia repair with mesh

laparoscopic

patients with ventral hernia operated as laparoscopic repair positioning TAPP mesh

Group Type EXPERIMENTAL

hernioplasty

Intervention Type PROCEDURE

ventral hernia repair with mesh

Interventions

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hernioplasty

ventral hernia repair with mesh

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All cases of midline ventral hernia fit for surgery

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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ahmed hussein abozeid ahmed

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hisham ryad

Role: STUDY_DIRECTOR

Central Contacts

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ahmed hussein

Role: CONTACT

Phone: 01091081032

Email: [email protected]

Ibrahim Mostafa

Role: CONTACT

Phone: 01090526849

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 35103166 (View on PubMed)

Other Identifiers

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ventral hernia repair

Identifier Type: -

Identifier Source: org_study_id