NCT01670851

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

2.5 years

First QC Date

August 19, 2012

Last Update Submit

December 7, 2015

Conditions

Rectal Cancer

Keywords

eLAPE,perineum,pelvic floor reconstruction

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (2)

  • Incidence of perineal herniation

    24 months

  • Incidence of parastomal hernia

    24 months

Study Arms (1)

Strattice

eLAPE

Device: Strattice

Interventions

StratticeDEVICE

Perineal reconstruction and stoma reinforcement with Strattice

Strattice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with low rectal carcinoma

You may qualify if:

  • Primary cancers undergoing curative surgery (R0)
  • Life expectancy \> 2 yrs
  • Neoadjuvant radiotherapy with or without chemotherapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Slagelse Hospital

Slagelse, Denmark

Location

Karolinska University Hospital

Stockholm, Sweden

Location

University Hospitals Leicester

Leicester, LE5 4PW, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2012

First Posted

August 22, 2012

Study Start

March 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

DK(1)SE(1)GB(1)