Condition category
Digestive System
Date applied
12/07/2006
Date assigned
11/08/2006
Last edited
25/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Tina Jane Adams

ORCID ID

Contact details

Tissue Science Laboratories
Victoria House
Victoria Road
Aldershot
Hampshire
GU11 1EJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RL100

Study information

Scientific title

Acronym

PROPHECI

Study hypothesis

Our hypothesis is that reinforcing the stoma trephine with Permacola® when the stoma is being formed is superior to the standard technique without reinforcement in terms of preventing herniation, and the use of Permacol® is associated with less morbidity, infection and pain.

Ethics approval

Approved by the Huntingdon Research Ethics Committee on 30/05/2006 (reference number: 06/Q0104/32).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Parastomal herniation

Intervention

We intend to randomise a cohort of patients who are undergoing permanent stoma formation for a variety of elective procedures between collagen mesh reinforcement of the stoma versus no mesh as control.

Intervention type

Drug

Phase

Not Specified

Drug names

Permacola®

Primary outcome measures

1. To determine the efficacy of Permacol® in reducing the incidence of parastomal hernia
2. To test whether the use of collagen mesh reinforcement is associated with lower rates of clinical herniation than no reinforcement. This will be evaluated at discharge and one, six, 12, 18 and 24 months post-operatively.

Secondary outcome measures

The secondary objectives of the study will be to determine differences in:
1. The radiological incidence of herniation as detected by Computerised Tomography (CT) scan and correlate this with the primary objective at 12 months
2. Complications associated with the technique used for the reinforcement. These will be evaluated at discharge and one, six, 12, 18 and 24 months post-operatively.
3. The handling characteristics, ease of insertion and suturing of the implant will be evaluated by the surgeon
4. Cost-benefit analysis comparing the cost of the reinforcement technique and the length of stay
5. Quality of life assessed using short-form-36 questionnaire (SF36) version two and EuroQol EQ-5D before and at one, six, 12, 18 and 24 months post-operatively

Overall trial start date

01/07/2006

Overall trial end date

01/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Requirement of an elective permanent stoma due to bowel disease
2. Written informed consent
3. Must be aged 18 -100 years and agree to the randomised procedure
4. If of childbearing potential, must have given a negative pregnancy test

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. If participant is taking part in another clinical study, which directly relates to this study
2. Suffering from an untreated metabolic or systemic illness (e.g. diabetes or rheumatoid arthritis or any immunological disease)
3. A diagnosis of mentally limiting conditions such as Alzheimer's or mental retardation or is unable to understand all study requirements
4. Is allergic to any porcine or collagen products
5. Has any indication of a Methicillin-Resistant Staphylococcus Aureus (MRSA) infection
6. Any indication of abdominal wall sepsis

Recruitment start date

01/07/2006

Recruitment end date

01/08/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Tissue Science Laboratories
Hampshire
GU11 1EJ
United Kingdom

Sponsor information

Organisation

Tissue Science Laboratories plc (UK)

Sponsor details

Victoria House
Victoria Road
Aldershot
Hampshire
GU11 1EJ
United Kingdom

Sponsor type

Industry

Website

http://www.tissuescience.com/

Funders

Funder type

Industry

Funder name

Tissue Science Laboratories plc (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes