A quest for sphincter saving surgery in ultra-low rectal tumors – a prospective cohort study. (SSULRET)
Study ID: TCTR20180724001
Current status: Completed
Last Updated: July 23, 2018
Tracking Information
Date of Registration in Primary Registry: July 23, 2018
Date of First Enrollment: January 01, 2014 (Actual)
Target Sample Size: 50
Last Updated Date: July 23, 2018
Primary Outcome(s):
  • Outcome name: Perioperative Data
       Metric/method of measurement: clinical records
       Time point: 30 days
       Safety Issue?: Yes


  • Key Secondary Outcomes:
  • Outcome name: pathological outcome
       Metric/method of measurement: clinical records
       Time point: 30 days
       Safety Issue?: No


  • Descriptive Information
    Public Title: A quest for sphincter saving surgery in ultra-low rectal tumors – a prospective cohort study.
    Scientific Title: A quest for sphincter saving surgery in ultra-low rectal tumors – a prospective cohort study. (SSULRET)
    Brief Summary:
    Detailed Description:
    Study Design: Allocation: Non-randomized
    Control: Active
    Study Endpoint Classification: Safety/Efficacy Study
    Intervention Model: No Intervention
    Number of Groups: 3
    Masking: (Masked Roles: )
    Primary Purpose: Treatment
    Study Phase: Phase 2/Phase 3
    Health Condition(s) or Problem(s) Studied: rectal cancer
    Study Groups:
  • Group: 1
  • Group Name: Abdomino-perineal resection
    Descriptions: Patients submitted to abdomino-perineal resection due to rectal cancer.
  • Group: 2
  • Group Name: Intersphinteric resection
    Descriptions: Patients submitted to intersphincteric resection due to rectal cancer.
  • Group: 3
  • Group Name: Transanal TME
    Descriptions: Patients submitted to Transanal Total Mesorectal Excision due to rectal cancer.
    Recruitment Information
    Recruitment Status: Completed
    Estimated Enrollment: 50
    Study Start Date (First enrollment): January 01, 2014
    Primary Completion Date: January 01, 2018
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 18 Years : Maximum 99 Years
    patients with low rectal cancer
    Exclusion Criteria
    patients with rectal cancer 5cm from the anal verge
    Accept Healthy Volunteers: No
    Countries of Recruitment Poland
    Contact for Public Queries:
    Contact for Public Query's Name: Mateusz Rubinkiewicz
    Phone: 48511503997
    Email: mrubinkiewicz@gmail.com
    Postal Address: Kopernika 21, Kraków
    State/Province: Małopolska        Postal Code: 31-501
    Country: Poland
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20180724001
    Secondary Identifying Numbers: Nil known
    Source(s) of Monetary or Material Supports: none
    Study Primary Sponsor: none
    Study Secondary Sponsor: 1.) none
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Mateusz Rubinkiewicz
    Phone: 48511503997
    Email: mrubinkiewicz@gmail.com
    Postal Address: Kopernika 21, Kraków
    State/Province: malopolska        Postal Code: 31-501
    Country: Poland
    Contact for Scientific Query's Name: Mateusz Rubinkiewicz
    Phone: 48511503997
    Email: mrubinkiewicz@gmail.com
    Postal Address: Kopernika 21, Kraków
    State/Province: Małopolska        Postal Code: 31-501
    Country: Poland
    Track changes

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