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

Not Applicable

• Conditions: Incisional LLQ Hernia
• Interventions: Procedure: Mesh augmentation; Procedure: Direct suture

• Registration Number: NCT04538768
• Lead Sponsor: Buccheri La Ferla Hospital, Palermo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-22
• Study First Submitted QC: 2020-09-03
• Last Update Submitted: 2020-09-03
• Study First Posted: 2020-09-04
• Last Update Posted: 2020-09-04
• Study Start: 2020-10
• Primary Completion: 2021-10
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• patients < 18 y.o.
• emergency surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesh Augmentated	Mesh augmentation	-
Direct Suture	Direct suture	-

Primary Outcome Measures

Name	Time	Method
rate of postoperative lateral incisional hernia after P4HB mesh placement vs direct fascia suture.	1 week to 18 months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
rate of seroma formation in P4HB mesh placement group vs direct fascia suture group.	1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery	outcome 5 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complications such as seroma.
rate of hematoma formation in P4HB mesh placement group vs direct fascia suture group.	1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery	outcome 6 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complications such as hematoma.
rate of surgical site infection in P4HB mesh placement group vs direct fascia suture group.	1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery	outcome 4 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complication such as surgical site infection.
surgical operation time in P4HB mesh placement group vs direct fascia suture group.	intraoperative	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.
length of hospital stay in P4HB mesh placement group vs direct fascia suture group.	From the starting date of the study until the date of its completion, assessed up to 18 months"	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).
assessment of quality of life (QoL) through QoL scale in P4HB mesh placement group vs direct fascia suture group.	18 months after surgery.	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.
cost effectiveness analysis of the P4HB mesh augmentation technique vs direct fascia suture group.	through study completion, an average of 1 year .	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.

Trial Locations

Locations (1)

Ospedale Buccheri La Ferla Palermo; 🇮🇹 Palermo, Italy