Parastomal Hernia
Conditions
Keywords
Ostomy creation, Parastomal hernia
Brief summary
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.
Interventions
DEVICEStrattice Reconstructive Matrix
Strattice will be placed as a fascial inlay to support stoma sites
OTHERStandard ostomy creation
Ostomy will be created as routinely performed
Sponsors
LifeCell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults * need for permanent ileostomy or colostomy
Exclusion criteria
* history of hernia at new ostomy site * has previously implanted surgical mesh at site of planned ostomy * requires a temporary ostomy * has need for multiple ostomies * is receiving chronic immunosuppression therapy, has MELD score of \> 17, has severe COPD, systemic infection, or known collagen disorder * is bedridden or otherwise non-ambulatory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay. | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Stoma Complications | 30 days |
| Stoma Quality of Life | Serially over 24 months |
Countries
United States
Participant flow
Pre-assignment details
7 subjects failed eligibility to continue to protocol-specific surgery after randomization.
Participants by arm
| Arm | Count |
|---|---|
| Strattice Fascial Inlay Strattice placed as a fascial inlay to support the ostomy site | 55 |
| Standard Ostomy Construction Ostomy created in the standard fashion | 58 |
| Total | 113 |
Baseline characteristics
| Characteristic | Strattice Fascial Inlay | Total | Standard Ostomy Construction |
|---|---|---|---|
| Age, Continuous | 60.25 years STANDARD_DEVIATION 13.65 | 59.7 years STANDARD_DEVIATION 13.97 | 59.14 years STANDARD_DEVIATION 14.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 105 Participants | 57 Participants |
| Region of Enrollment United States | 55 participants | 113 participants | 58 participants |
| Sex: Female, Male Female | 25 Participants | 54 Participants | 29 Participants |
| Sex: Female, Male Male | 30 Participants | 59 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 54 / 55 | 55 / 58 |
| serious Total, serious adverse events | 37 / 55 | 37 / 58 |
Outcome results
Primary
Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.
Time frame: 24 months
Population: Efficacy Evaluable Population (received assigned treatment, completed all protocol-required evaluations, no major protocol violations).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Strattice Fascial Inlay | Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay. | 6 participants |
| Standard Ostomy Construction | Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay. | 7 participants |
Secondary
Stoma Complications
Time frame: 30 days
Secondary
Stoma Complications
Time frame: more than 1 month postoperatively
Secondary
Stoma Quality of Life
Time frame: Serially over 24 months