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

December 7, 2015 updated by: University Hospitals, Leicester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Slagelse, Denmark
        • Slagelse Hospital
      • Stockholm, Sweden
        • Karolinska University Hospital
      • Leicester, United Kingdom, LE5 4PW
        • University Hospitals Leicester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with low rectal carcinoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Strattice
eLAPE
Perineal reconstruction and stoma reinforcement with Strattice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of perineal herniation
Time Frame: 24 months
Incidence of perineal hernia
24 months
Incidence of parastomal hernia
Time Frame: 24 months
Stoma will be assessed for herniation at Months 3, 6, 12 and 24
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

August 19, 2012

First Submitted That Met QC Criteria

August 21, 2012

First Posted (ESTIMATE)

August 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

December 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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