Rectal CancerPRESSURNCT01670851
Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement
An observational study of Rectal Cancer, run by University Hospitals, Leicester at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Strattice
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with low rectal carcinoma
Who may be able to join
- Primary cancers undergoing curative surgery (R0)
- Life expectancy > 2 yrs
- Neoadjuvant radiotherapy with or without chemotherapy
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Strattice
- Keywords
- eLAPE,, perineum,, pelvic floor reconstruction
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StratticeDevice
Perineal reconstruction and stoma reinforcement with Strattice
| Study group | Role | What they receive |
|---|---|---|
| Strattice | eLAPE Receives: Device: Strattice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineal wound healing
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.
Measured: 12 months
Secondary outcomes (2)
Incidence of perineal herniation
Incidence of perineal hernia
Measured: 24 months
Incidence of parastomal hernia
Stoma will be assessed for herniation at Months 3, 6, 12 and 24
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startMar 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Slagelse Hospital
- Responsible party
- Sponsor
- Investigators
- Baljit Singh, FRCS, FACS, Principal investigator, University Hospital Leicester, UKSanjay Chaudhri, FRCS, Principal investigator, University Hospital Leicester, UKPer J Nilsson, MD, Principal investigator, Karolinska InstitutetPierre J Maina, MD, Principal investigator, Slagelse Hospital, DenmarkW Bemelman, MD, Principal investigator, Academic Medical Center, Amsterdam, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670851
- Sponsor's protocol ID
- ISIS.11.01.06.BS/SC
- Acronym
- PRESSUR
- Status last verified
- Dec 2015
- First submitted
- 19 Aug 2012
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement
- ClinicalTrials.gov ID
- NCT01670851
- Acronym / sponsor ID
- PRESSUR / ISIS.11.01.06.BS/SC
- Conditions
- Rectal Cancer
- Keywords
- eLAPE,, perineum,, pelvic floor reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Slagelse Hospital
- Study start
- Mar 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strattice | – | Device: StratticeeLAPE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with low rectal carcinoma
Key inclusion criteria (3 listed)
- Primary cancers undergoing curative surgery (R0)
- Life expectancy > 2 yrs
- Neoadjuvant radiotherapy with or without chemotherapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StratticePerineal reconstruction and stoma reinforcement with Strattice | Device | Strattice |
Primary outcome
Perineal wound healing
Time frame: 12 months
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.
2 secondary outcomes
Incidence of perineal herniation
Time frame: 24 months
Incidence of parastomal hernia
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baljit Singh, FRCS, FACS principal investigator
University Hospital Leicester, UK
Sanjay Chaudhri, FRCS principal investigator
University Hospital Leicester, UK
Per J Nilsson, MD principal investigator
Karolinska Institutet
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by University Hospitals, Leicester at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineal wound healing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.