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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Incisional LLQ Hernia
• Intervention / Treatment: Procedure: Mesh augmentation; Procedure: Direct suture

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leo Licari, MD; Phone Number: +39 3401710089; Email: lele.licari@gmail.com
• Study Contact Backup: Name: Cosimo Callari, MD; Phone Number: +39 339 4574404; Email: cosimo.callari@gmail.com

Study Locations

• Italy
  • Palermo, Italy, 90100
    • Ospedale Buccheri La Ferla Palermo
    • Contact: Leo Licari, MD; Phone Number: +39 3401710089; Email: lele.licari@gmail.com
    • Contact: Cosimo Callari, MD; Phone Number: +39 3394574404; Email: cosimo.callari@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patients < 18 y.o.
• emergency surgery

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 .

Collaborators and Investigators

• Sponsor: Buccheri La Ferla Hospital, Palermo
• Investigators: Study Director: Leo Licari, MD, Ospedale Buccheri La Ferla Palermo; University of Palermo - Department of Surgical, Oncological and Oral Sciences; Study Chair: Cosimo Callari, MD, Ospedale Buccheri La Ferla Palermo

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: August 22, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: prevention; lateral incisional hernia; mesh augmentation; stomal closure
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 20082020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No