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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 : Unknown
Verified May 2022 by Umberto Bracale, Federico II University.
Recruitment status was:  Recruiting
First Posted : June 1, 2022
Last Update Posted : June 3, 2022
Sponsor:
Information provided by (Responsible Party):
Umberto Bracale, Federico II University

Tracking Information
First Submitted Date May 24, 2022
First Posted Date June 1, 2022
Last Update Posted Date June 3, 2022
Actual Study Start Date May 17, 2021
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2022)		 Incisional hernia rate [ Time Frame: at 24 months ]
CT scan or Ultrasound as imaging to detect incisional hernia
Original Primary Outcome Measures
 (submitted: May 26, 2022)		 Incisional hernia rate [ Time Frame: at 24 months ]
Imaging to detect incisional hernia
Change History
Current Secondary Outcome Measures
 (submitted: May 26, 2022)
  • Early and Long-term Complication Rates [ Time Frame: after surgery to 24 months ]
    Clavien-Dindo classification
  • Postoperative pain [ Time Frame: after surgery to 24 months ]
    Visual analogue scales (VAS) Range: 1-100. Higher score correlates with more pain
  • 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
  • Budget Impact Analysis [ Time Frame: after surgery to 24 months ]
    Healthcare Cost Analysis including direct costs (fixed and variable)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure (PRINCESS)
Official Title Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure
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 .
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population General and teaching hospitals
Condition Incisional Hernia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 26, 2022)		 203
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2024
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT05400083
Other Study ID Numbers 471/20
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Umberto Bracale, Federico II University
Original Responsible Party Same as current
Current Study Sponsor Federico II University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Federico II University
Verification Date May 2022