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

Primary Purpose

Incisional LLQ Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mesh augmentation
Direct suture
Sponsored by
Buccheri La Ferla Hospital, Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incisional LLQ Hernia focused on measuring lateral incisional hernia, mesh augmentation, prevention, stomal closure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • patients < 18 y.o.
  • emergency surgery

Sites / Locations

  • Ospedale Buccheri La Ferla Palermo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Mesh Augmentated

Direct Suture

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.
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.
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.
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.

Full Information

First Posted
August 22, 2020
Last Updated
September 3, 2020
Sponsor
Buccheri La Ferla Hospital, Palermo
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1. Study Identification

Unique Protocol Identification Number
NCT04538768
Brief Title
Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh
Official Title
Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Buccheri La Ferla Hospital, Palermo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional LLQ Hernia
Keywords
lateral incisional hernia, mesh augmentation, prevention, stomal closure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesh Augmentated
Arm Type
Experimental
Arm Title
Direct Suture
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Mesh augmentation
Intervention Description
P4HB retromuscular mesh placement for prevention of lateral incisional hernia after stomal closure
Intervention Type
Procedure
Intervention Name(s)
Direct suture
Intervention Description
direct fascia suture
Primary Outcome Measure Information:
Title
rate of postoperative lateral incisional hernia after P4HB mesh placement vs direct fascia suture.
Description
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.
Time Frame
1 week to 18 months after surgery
Secondary Outcome Measure Information:
Title
surgical operation time in P4HB mesh placement group vs direct fascia suture group.
Description
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.
Time Frame
intraoperative
Title
length of hospital stay in P4HB mesh placement group vs direct fascia suture group.
Description
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).
Time Frame
From the starting date of the study until the date of its completion, assessed up to 18 months"
Title
rate of surgical site infection in P4HB mesh placement group vs direct fascia suture group.
Description
outcome 4 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complication such as surgical site infection.
Time Frame
1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
Title
rate of seroma formation in P4HB mesh placement group vs direct fascia suture group.
Description
outcome 5 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complications such as seroma.
Time Frame
1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
Title
rate of hematoma formation in P4HB mesh placement group vs direct fascia suture group.
Description
outcome 6 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complications such as hematoma.
Time Frame
1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
Title
assessment of quality of life (QoL) through QoL scale in P4HB mesh placement group vs direct fascia suture group.
Description
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.
Time Frame
18 months after surgery.
Title
cost effectiveness analysis of the P4HB mesh augmentation technique vs direct fascia suture group.
Description
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.
Time Frame
through study completion, an average of 1 year .

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients > 18 y.o. stomal closure elective surgery Exclusion Criteria: patients < 18 y.o. emergency surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leo Licari, MD
Phone
+39 3401710089
Email
lele.licari@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cosimo Callari, MD
Phone
+39 339 4574404
Email
cosimo.callari@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo Licari, MD
Organizational Affiliation
Ospedale Buccheri La Ferla Palermo; University of Palermo - Department of Surgical, Oncological and Oral Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cosimo Callari, MD
Organizational Affiliation
Ospedale Buccheri La Ferla Palermo
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Buccheri La Ferla Palermo
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leo Licari, MD
Phone
+39 3401710089
Email
lele.licari@gmail.com
First Name & Middle Initial & Last Name & Degree
Cosimo Callari, MD
Phone
+39 3394574404
Email
cosimo.callari@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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