NCT05400083

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 24, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

June 3, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

May 24, 2022

Last Update Submit

May 31, 2022

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

  • Incisional hernia rate

    CT scan or Ultrasound as imaging to detect incisional hernia

    at 24 months

Secondary Outcomes (4)

  • Early and Long-term Complication Rates

    after surgery to 24 months

  • Postoperative pain

    after surgery to 24 months

  • Quality of life by Carolinas Comfort Scale (CCS) and Euro-Qol 5D-5L questionnaires

    after surgery to 24 months

  • Budget Impact Analysis

    after surgery to 24 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General and teaching hospitals

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minimally Invasive General and Oncologic Surgery Unit - Univesity of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Central Study Contacts

Umberto Bracale, Prof

CONTACT

+390817462544umbertobracale@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 24, 2022

First Posted

June 1, 2022

Study Start

May 17, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2024

Last Updated

June 3, 2022

Record last verified: 2022-05

Locations

IT(1)