Completed
PRESSURPerineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement
What is being collected
Device Data
Collected from today forward - ProspectiveDevice
Who is being recruted
Digestive System Diseases+8
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Over 18 Years
+7 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: March 2013
Summary
Principal SponsorUniversity Hospitals, Leicester
Last updated: December 8, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorUniversity Hospitals, Leicester
Last updated: December 8, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal NeoplasmsRectal Neoplasms
Criteria
3 inclusion criteria required to participate
Life expectancy > 2 yrs
Neoadjuvant radiotherapy with or without chemotherapy
Primary cancers undergoing curative surgery (R0)
4 exclusion criteria prevent from participating
Co-morbidities of: systemic infection, chronic liver failure, chronic renal failure, HIV, Hepatitis C, other advanced/metastatic cancer, collagen disorder
Pelvic extenteration or extended resections
Previously irradiated patients (i.e. radiation therapy for a previous cancer)
sensitivity to porcine derived products or polysorbate
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Karolinska University Hospital
Stockholm, SwedenUniversity Hospitals Leicester
Leicester, United KingdomCompleted3 Study Centers