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

Study Overview
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Brief Summary
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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.

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

Conditions
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Incisional LLQ Hernia

Intervention / Treatment
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* Procedure: Mesh augmentation
* Procedure: Direct suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients > 18 y.o. stomal closure elective surgery Exclusion Criteria: patients < 18 y.o. emergency surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesh Augmentated<br> | Procedure: Mesh augmentation<br>* P4HB retromuscular mesh placement for prevention of lateral incisional hernia after stomal closure<br>|
| Other: Direct Suture<br> | Procedure: Direct suture<br>* direct fascia suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of postoperative lateral incisional hernia after P4HB mesh placement vs direct fascia suture. | the outcome 1 will be assessed through clinical examination during follow up time. when the suspicion of incisional hernia will be hypothesized the patients will be conducted to perform US of the abdomen and CT scan of the abdomen if strictly required to confirm the suspicion. | 1 week to 18 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical operation time in P4HB mesh placement group vs direct fascia suture group. | outcome 2 will be assessed through the measurement of the length of surgical operation. The length of the surgical operation will be measured in minutes from the incision of the skin to the suture of the skin. data will be compared with those of the control arm (direct fascia suture) to understand the feasibility of the technique proposed. | intraoperative | 
| length of hospital stay in P4HB mesh placement group vs direct fascia suture group. | outcome 3 will be assessed through the measurement of the length of the hospital stay. The length of hospital stay will be measured in days from admission to dimission of the patient. Data will be compared with those of the control arm (direct fascia suture). | From the starting date of the study until the date of its completion, assessed up to 18 months | 
| rate of surgical site infection in P4HB mesh placement group vs direct fascia suture group. | outcome 4 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complication such as surgical site infection. | 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery | 
| rate of seroma formation in P4HB mesh placement group vs direct fascia suture group. | outcome 5 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complications such as seroma. | 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery | 
| rate of hematoma formation in P4HB mesh placement group vs direct fascia suture group. | outcome 6 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complications such as hematoma. | 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery | 
| assessment of quality of life (QoL) through QoL scale in P4HB mesh placement group vs direct fascia suture group. | outcome 7 will be assessed through assessment of the postoperative QoL. The SF-36 questionnaire will be administered post-operatively. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. The SF-36, as described in the name, is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. | 18 months after surgery. | 
| cost effectiveness analysis of the P4HB mesh augmentation technique vs direct fascia suture group. | the outcome 8 will be assessed through the collection of data about the total costs for the surgical operation and the hospitalization considering materials and mesh used. The analysis will be used to compare the costs of the technique proposed with those of the incisional hernia management in order to conduct a cost effectiveness analysis. | through study completion, an average of 1 year . | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lateral incisional hernia, mesh augmentation, prevention, stomal closure