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


N/A
18 Years
N/A
Not Enrolling
Both
Rectal Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Perineal wound healing

Outcome Description:

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.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Baljit Singh, FRCS, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Leicester, UK

Authority:

United Kingdom: National Health Service

Study ID:

ISIS.11.01.06.BS/SC

NCT ID:

NCT01670851

Start Date:

March 2013

Completion Date:

September 2015

Related Keywords:

  • Rectal Cancer
  • eLAPE,
  • perineum,
  • pelvic floor reconstruction
  • Rectal Neoplasms

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