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

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ClinicalTrials.gov Identifier: NCT04538768
Recruitment Status : Not yet recruiting
First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Leo Licari, Buccheri La Ferla Hospital, Palermo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Incisional LLQ Hernia Procedure: Mesh augmentation Procedure: Direct suture Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mesh Augmentated Procedure: Mesh augmentation
P4HB retromuscular mesh placement for prevention of lateral incisional hernia after stomal closure
Direct Suture Procedure: Direct suture
direct fascia suture


Outcome Measures
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Primary Outcome Measures :
  1. rate of postoperative lateral incisional hernia after P4HB mesh placement vs direct fascia suture. [ Time Frame: 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 :
  1. surgical operation time in P4HB mesh placement group vs direct fascia suture group. [ Time Frame: 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.

  2. length of hospital stay in P4HB mesh placement group vs direct fascia suture group. [ Time Frame: 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).

  3. rate of surgical site infection in P4HB mesh placement group vs direct fascia suture group. [ 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 ]
    outcome 4 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complication such as surgical site infection.

  4. rate of seroma formation in P4HB mesh placement group vs direct fascia suture group. [ 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 ]
    outcome 5 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complications such as seroma.

  5. rate of hematoma formation in P4HB mesh placement group vs direct fascia suture group. [ 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 ]
    outcome 6 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complications such as hematoma.

  6. assessment of quality of life (QoL) through QoL scale in P4HB mesh placement group vs direct fascia suture group. [ Time Frame: 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.


  7. cost effectiveness analysis of the P4HB mesh augmentation technique vs direct fascia suture group. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients < 18 y.o.
  • emergency surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04538768


Contacts
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Contact: Leo Licari, MD +39 3401710089 lele.licari@gmail.com
Contact: Cosimo Callari, MD +39 339 4574404 cosimo.callari@gmail.com

Locations
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Italy
Ospedale Buccheri La Ferla Palermo
Palermo, Italy, 90100
Contact: Leo Licari, MD    +39 3401710089    lele.licari@gmail.com   
Contact: Cosimo Callari, MD    +39 3394574404    cosimo.callari@gmail.com   
Sponsors and Collaborators
Buccheri La Ferla Hospital, Palermo
Investigators
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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
More Information
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Responsible Party: Leo Licari, Principal Investigator, Buccheri La Ferla Hospital, Palermo
ClinicalTrials.gov Identifier: NCT04538768    
Other Study ID Numbers: 20082020
First Posted: September 4, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leo Licari, Buccheri La Ferla Hospital, Palermo:
lateral incisional hernia
mesh augmentation
prevention
stomal closure
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes