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

This study is not yet open for participant recruitment.
Verified February 2013 by University Hospitals, Leicester
Sponsor:
Collaborators:
Karolinska University Hospital
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Slagelse Hospital
Information provided by (Responsible Party):
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT01670851
First received: August 19, 2012
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • Perineal wound healing [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Incidence of perineal hernia

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


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670851

Locations
Denmark
Slagelse Hospital Not yet recruiting
Slagelse, Denmark
Netherlands
Academic Medical Centre Not yet recruiting
Amsterdam, Netherlands
Sweden
Karolinska University Hospital Not yet recruiting
Stockholm, Sweden
United Kingdom
University Hospitals Leicester Not yet recruiting
Leicester, United Kingdom, LE5 4PW
Contact: Baljit Singh, FRCS, FACS            
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

No publications provided

Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT01670851     History of Changes
Other Study ID Numbers: ISIS.11.01.06.BS/SC
Study First Received: August 19, 2012
Last Updated: February 19, 2013
Health Authority: United Kingdom: National Health Service

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

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013