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Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement (PRESSUR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01670851
First Posted: August 22, 2012
Last Update Posted: December 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Karolinska University Hospital
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Slagelse Hospital
Information provided by (Responsible Party):
University Hospitals, Leicester
  Purpose
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.

Condition Intervention
Rectal Cancer Device: Strattice

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement

Resource links provided by NLM:


Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Incidence of perineal herniation [ Time Frame: 24 months ]
    Incidence of perineal hernia

  • Incidence of parastomal hernia [ Time Frame: 24 months ]
    Stoma will be assessed for herniation at Months 3, 6, 12 and 24


Enrollment: 20
Study Start Date: March 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Strattice
eLAPE
Device: Strattice
Perineal reconstruction and stoma reinforcement with Strattice

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with low rectal carcinoma
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670851


Locations
Denmark
Slagelse Hospital
Slagelse, Denmark
Sweden
Karolinska University Hospital
Stockholm, Sweden
United Kingdom
University Hospitals Leicester
Leicester, United Kingdom, LE5 4PW
Sponsors and Collaborators
University Hospitals, Leicester
Karolinska University Hospital
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Slagelse Hospital
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
  More Information

Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT01670851     History of Changes
Other Study ID Numbers: ISIS.11.01.06.BS/SC
First Submitted: August 19, 2012
First Posted: August 22, 2012
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by University Hospitals, Leicester:
eLAPE,
perineum,
pelvic floor reconstruction