Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01670851

Acronym

PRESSUR

Enrollment

Registered

2012-08-22

Start date

2013-03-31

Completion date

2015-09-30

Last updated

2015-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

eLAPE,, perineum,, pelvic floor reconstruction

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.

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.

Interventions

DEVICEStrattice

Perineal reconstruction and stoma reinforcement with Strattice

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Perineal wound healing	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

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

Countries

Denmark, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026