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OpenTrials
Completed

NCT Number: NCT01670851

Perineal Reconstruction Following eLAPE 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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Slagelse Hospital, Slagelse, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strattice

Device

Perineal reconstruction and stoma reinforcement with Strattice

Primary outcomes

  1. 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 outcomes

  1. Incidence of perineal herniation

    Time frame: 24 months

    Incidence of perineal hernia

  2. Incidence of parastomal hernia

    Time frame: 24 months

    Stoma will be assessed for herniation at Months 3, 6, 12 and 24

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Karolinska University Hospital
  • Slagelse Hospital

Registry information

Official study title

Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement

Acronym: PRESSUR

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 22, 2012
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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