- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01670851
Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement (PRESSUR)
December 7, 2015 updated by: University Hospitals, Leicester
Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement
This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.
Study Overview
Detailed Description
About 40 subjects will be enrolled from 4 centers over approx 24 months.
Subjects will all be undergoing extralevator abdominoperineal excision with concomitant ostomy creation.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Slagelse, Denmark
- Slagelse Hospital
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Stockholm, Sweden
- Karolinska University Hospital
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Leicester, United Kingdom, LE5 4PW
- University Hospitals Leicester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with low rectal carcinoma
Description
Inclusion Criteria:
- Primary cancers undergoing curative surgery (R0)
- Life expectancy > 2 yrs
- Neoadjuvant radiotherapy with or without chemotherapy
Exclusion Criteria:
- Pelvic extenteration or extended resections
- Previously irradiated patients (i.e. radiation therapy for a previous cancer)
- Co-morbidities of: systemic infection, chronic liver failure, chronic renal failure, HIV, Hepatitis C, other advanced/metastatic cancer, collagen disorder
- sensitivity to porcine derived products or polysorbate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Strattice
eLAPE
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Perineal reconstruction and stoma reinforcement with Strattice
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Perineal wound healing
Time Frame: 12 months
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Perineal wound healing will be assessed using the Southamptom Wound Scoring System and perineal pain assessed using a visual analogue scale (VAS) daily during hospital stay and then POD 7, 30 and months 3, 6 and 12.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of perineal herniation
Time Frame: 24 months
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Incidence of perineal hernia
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24 months
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Incidence of parastomal hernia
Time Frame: 24 months
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Stoma will be assessed for herniation at Months 3, 6, 12 and 24
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Baljit Singh, FRCS, FACS, University Hospital Leicester, UK
- Principal Investigator: Sanjay Chaudhri, FRCS, University Hospital Leicester, UK
- Principal Investigator: Per J Nilsson, MD, Karolinska Institutet
- Principal Investigator: Pierre J Maina, MD, Slagelse Hospital, Denmark
- Principal Investigator: W Bemelman, MD, Academic Medical Center, Amsterdam, Netherlands
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (ACTUAL)
September 1, 2015
Study Completion (ACTUAL)
September 1, 2015
Study Registration Dates
First Submitted
August 19, 2012
First Submitted That Met QC Criteria
August 21, 2012
First Posted (ESTIMATE)
August 22, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
December 8, 2015
Last Update Submitted That Met QC Criteria
December 7, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISIS.11.01.06.BS/SC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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