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Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure (PRINCESS) (PRINCESS)

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ClinicalTrials.gov Identifier: NCT05400083
Recruitment Status : Recruiting
First Posted : June 1, 2022
Last Update Posted : June 3, 2022
Sponsor:
Information provided by (Responsible Party):
Umberto Bracale, Federico II University

Study Description
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Brief Summary:

Prophylactic mesh reinforcement of the abdominal wall at the site of temporary ileostomy closure is effective in preventing postoperative incisional hernia.

This prospective, multicenter, observational study will evaluate performance of Phasix biosynthetic mesh when used to reinforce fascial closure .


Condition or disease
Incisional Hernia

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 203 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure
Actual Study Start Date : May 17, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Incisional hernia rate [ Time Frame: at 24 months ]
    CT scan or Ultrasound as imaging to detect incisional hernia


Secondary Outcome Measures :
  1. Early and Long-term Complication Rates [ Time Frame: after surgery to 24 months ]
    Clavien-Dindo classification

  2. Postoperative pain [ Time Frame: after surgery to 24 months ]
    Visual analogue scales (VAS) Range: 1-100. Higher score correlates with more pain

  3. Quality of life by Carolinas Comfort Scale (CCS) and Euro-Qol 5D-5L questionnaires [ Time Frame: after surgery to 24 months ]
    CCS - Range: 0-115. Higher score correlates with worse outcome

  4. Budget Impact Analysis [ Time Frame: after surgery to 24 months ]
    Healthcare Cost Analysis including direct costs (fixed and variable)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
General and teaching hospitals
Criteria

Inclusion Criteria:

  • Subjects will be informed about the study, and will have read; understood and signed the informed consent
  • Subjects of either gender that are at least the age of 18 years
  • Subjects will be undergoing ileostomy reversal with retromuscular placement technique of the Phasix biosynthetic mesh reinforcement

Exclusion Criteria:

  • Subjects who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study
  • Subjects with parastomal hernia or midline incisional hernia
  • Subjects who required midline laparotomy during ileostomy reversal
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): NCT05400083


Contacts
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Contact: Umberto Bracale, Prof +390817462544 umbertobracale@gmail.com

Locations
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Italy
Minimally Invasive General and Oncologic Surgery Unit - Univesity of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Umberto Bracale, Prof    +390817462544      
Sub-Investigator: Roberto Peltrini, Dr         
Sponsors and Collaborators
Federico II University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Umberto Bracale, Prof., Federico II University
ClinicalTrials.gov Identifier: NCT05400083    
Other Study ID Numbers: 471/20
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes