Incisional HerniaPRINCESSNCT05400083
Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure (PRINCESS)
An observational study of Incisional Hernia, run by Federico II University at 1 site in Italy.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- How many people
- 203 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2021to May 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: General and teaching hospitals
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Minimally Invasive General and Oncologic Surgery Unit - Univesity of Naples Federico II
Naples, 80131
Umberto Bracale, Prof, +390817462544
Roberto Peltrini, Dr
About this study
Official title: Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure
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 .
- Conditions
- Incisional Hernia
- Medical subject headings
- Incisional Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia rate
CT scan or Ultrasound as imaging to detect incisional hernia
Measured: at 24 months
Secondary outcomes (4)
Early and Long-term Complication Rates
Clavien-Dindo classification
Measured: after surgery to 24 months
Postoperative pain
Visual analogue scales (VAS) Range: 1-100. Higher score correlates with more pain
Measured: after surgery to 24 months
Quality of life by Carolinas Comfort Scale (CCS) and Euro-Qol 5D-5L questionnaires
CCS - Range: 0-115. Higher score correlates with worse outcome
Measured: after surgery to 24 months
Budget Impact Analysis
Healthcare Cost Analysis including direct costs (fixed and variable)
Measured: after surgery to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start17 May 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umberto Bracale, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400083
- Sponsor's protocol ID
- 471/20
- Acronym
- PRINCESS
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure
- ClinicalTrials.gov ID
- NCT05400083
- Acronym / sponsor ID
- PRINCESS / 471/20
- Conditions
- Incisional Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- General and teaching hospitals
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incisional hernia rate
Time frame: at 24 months
CT scan or Ultrasound as imaging to detect incisional hernia
4 secondary outcomes
Early and Long-term Complication Rates
Time frame: after surgery to 24 months
Postoperative pain
Time frame: after surgery to 24 months
Quality of life by Carolinas Comfort Scale (CCS) and Euro-Qol 5D-5L questionnaires
Time frame: after surgery to 24 months
Budget Impact Analysis
Time frame: after surgery to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umberto Bracale, Prof (+390817462544, umbertobracale@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia rate (time frame: at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.