MedDataX Logo

Trial Outcomes & Findings for Prevention of Parastomal Hernia by Mesh Placement (NCT NCT02404545)

NCT ID: NCT02404545

Last Updated: 2017-09-25

Results Overview

Rate of reduction of the incidence of parastomal hernia in study participants, as assessed by physical examination

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

18 months

Results posted on

2017-09-25

Participant Flow

Participant milestones

Participant milestones
Measure
Group 1 - Ideal Conduit No Mesh
No mesh will be placed at the time of radical cystectomy and ileal conduit.
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.
Overall Study
STARTED
6
6
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
6
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Group 1 - Ideal Conduit No Mesh
No mesh will be placed at the time of radical cystectomy and ileal conduit.
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.
Overall Study
Sponsor Termination
6
6

Baseline Characteristics

Prevention of Parastomal Hernia by Mesh Placement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1 - Ideal Conduit No Mesh
n=6 Participants
No mesh will be placed at the time of radical cystectomy and ileal conduit.
Group 2 - Ileal Conduit With Mesh
n=6 Participants
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.
Total
n=12 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
Age, Categorical
>=65 years
5 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
5 Participants
n=7 Participants
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
4 Participants
n=7 Participants
9 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Rate of reduction of the incidence of parastomal hernia in study participants, as assessed by physical examination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Group 1 - Ideal Conduit No Mesh

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 2 - Ileal Conduit With Mesh

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Murugesan Manoharan MD, FRCS (Eng), FRACS (Urol)

Baptist Health South Florida - Miami Cancer Institute

Phone: 305-595-2141

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place