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

This study has been completed.
Karolinska University Hospital
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Slagelse Hospital
Information provided by (Responsible Party):
University Hospitals, Leicester Identifier:
First received: August 19, 2012
Last updated: December 7, 2015
Last verified: December 2015
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
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.

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

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
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Please refer to this study by its identifier: NCT01670851

Slagelse Hospital
Slagelse, Denmark
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
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 Identifier: NCT01670851     History of Changes
Other Study ID Numbers: ISIS.11.01.06.BS/SC
Study First Received: August 19, 2012
Last Updated: December 7, 2015

Keywords provided by University Hospitals, Leicester:
pelvic floor reconstruction

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases processed this record on May 25, 2017