Parastomal Hernia
Conditions
Keywords
Hernia, Mesh, Ileal conduit
Brief summary
Concurrent placement of a mesh during formation of ileal conduit will decrease the incidence of parastomal hernia and associated complications.
Detailed description
Subject to inclusion and exclusion criteria, patients will be randomized 1:1 to the control and intervention groups: Randomization groups: * Group 1 (control): Ileal Conduit * Group 2 (intervention): Ileal conduit with concurrent mesh placement. Ethicon PHYSIOMESH composite mesh will be utilized for this study. This is a composite mesh with a reduced polypropylene content. It is a widely used, commercially available hernia mesh, and its use and placement are simple and well described. The mesh will be placed at the time of radical cystectomy and ileal conduit. A small circle of mesh, the diameter of the ileal conduit, will be excised to allow for fitment around the ileal conduit. The mesh will be placed so that it encompasses the ileal conduit in a non-constricting manner, and will be sutured to the anterior abdominal wall. Product will be stored in a secure, sterile manner at the UMH operating room sterile supply room, and in accordance with institutional policies. Patients from both groups will be followed up in a standard fashion. Follow up visits and clinical assessment will be at 6 weeks after surgery, 3 monthly during the first year, then every 6 months for at least 5 years. During each visit, patients will be clinically evaluated for the presence or absence of parastomal hernia, and any routine surveillance radiology imaging will be reviewed. Parastomal hernia is clinically defined as an incisional hernia at the site of the ileal conduit stoma. This may be clinically apparent by examining the patient during performance of abdominal straining or Valsalva maneuver, or may be evident on radiology imaging.
Interventions
DEVICEEthicon Physiomesh
Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit.
Sponsors
Ethicon, Inc.
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients eligible to undergo urinary diversion with ileal conduit. 2. Patients with the ability to understand and willingness to sign a written informed consent document. 3. Men and Women aged 18 to 80 years.
Exclusion criteria
1. Patients unable or unwilling to consent to the proposed surgery 2. Pregnant women 3. Patients with prior ileal conduit surgery undergoing revision.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Reduction of the Incidence of Parastomal Hernia | 18 months | Rate of reduction of the incidence of parastomal hernia in study participants, as assessed by physical examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Develop Mesh Related Complications | 60 months | Assessed by physical examination including: * Mesh erosion and infection * Stomal stenosis and necrosis * Frequency of stoma pouch appliance changes. * Record by physical exam the incidence of parastomal hernia at 5 years. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - Ideal Conduit No Mesh No mesh will be placed at the time of radical cystectomy and ileal conduit. | 6 |
| Group 2 - Ileal Conduit With Mesh Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.
Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Sponsor Termination | 6 | 6 |
Baseline characteristics
| Characteristic | Group 1 - Ideal Conduit No Mesh | Group 2 - Ileal Conduit With Mesh | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| 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 | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment United States | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Rate of Reduction of the Incidence of Parastomal Hernia
Rate of reduction of the incidence of parastomal hernia in study participants, as assessed by physical examination
Time frame: 18 months
Population: The study required a minimum of 13 participants enrolled per arm for analysis of this outcome measure. Due to the manufacturer's (Ethicon) termination of the Physiomesh device, the study was prematurely terminated with fewer than minimum number of participants required on each arm, and the data were not analyzed.
Secondary
Number of Participants Who Develop Mesh Related Complications
Assessed by physical examination including: * Mesh erosion and infection * Stomal stenosis and necrosis * Frequency of stoma pouch appliance changes. * Record by physical exam the incidence of parastomal hernia at 5 years.
Time frame: 60 months
Population: The study required a minimum of 13 participants enrolled per arm for analysis of this outcome measure. Due to the manufacturer's (Ethicon) termination of the Physiomesh device, the study was prematurely terminated with fewer than minimum number of participants required on each arm, and the data were not analyzed.