Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh

Buccheri La Ferla Hospital, Palermo

Status: Unknown

Conditions: Incisional LLQ Hernia

Treatments: Procedure: Direct suture; Procedure: Mesh augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT04538768

20082020

Details and patient eligibility

About

The aim of the study is to determine whether the use of the P4HB retro muscular mesh can prevent the lateral incisional hernia after stomal closure.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients > 18 y.o.
• stomal closure
• elective surgery

Exclusion criteria

• patients < 18 y.o.
• emergency surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Mesh Augmentated

Experimental group

Treatment:

Procedure: Mesh augmentation

Direct Suture

Other group

Treatment:

Procedure: Direct suture