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Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study

Sponsor
Azienda Unità Sanitaria Locale della Romagna (Other)
Overall Status
Completed
CT.gov ID
NCT05913453
Collaborator
(none)
77
Enrollment
1
Location
2
Actual Duration (Months)
37.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Among advanced resection techniques, endoscopic full thickness resection (EFTR) allows closure and full-thickness resection by the use of the non-exposed full thickness resection device (FTRD). The study is a retrospective analysis of technical failure occurring during colorectal full-thickness resection. Full thickness resection is a safe and effective procedure for "difficult" colorectal lesions. However, technical failure can occur and to date there is no evidence about type and clinical consequences in this setting.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study is a multicentre retrospective study involving centres with experience in advanced colorectal resections.

    Each centre is invited to submit information about the Centre and to report alle the consecutive cases corresponding to technical failure.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    77 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study
    Actual Study Start Date :
    Nov 30, 2022
    Actual Primary Completion Date :
    Dec 31, 2022
    Actual Study Completion Date :
    Jan 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Procedures corresponding to technical failure

    Outcome Measures

    Primary Outcome Measures

    1. Technical failure rate and classification [2014 - 2022]

    Secondary Outcome Measures

    1. Conservative Management of technical failure [2014-2022]

      Performance of rescue endoscopic resection

    2. Clinical success (R0 resection) [2014-2022]

    3. Complication rate [2014-2022]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Consecutive colorectal EFTR procedures with technical failure by using OVESCO Full Thickness Resection Device
    Exclusion Criteria:

    • EFTR performed by exposed techniques and/or devices different from FTRD

    • Patients not able to give informed consent for data collection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ospedale Morgagni-Pierantoni Forlì Forlì-Cesena Italy

    Sponsors and Collaborators

    • Azienda Unità Sanitaria Locale della Romagna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carlo Fabbri, Dr., Azienda Unità Sanitaria Locale della Romagna
    ClinicalTrials.gov Identifier:
    NCT05913453
    Other Study ID Numbers:
    • 2993
    First Posted:
    Jun 22, 2023
    Last Update Posted:
    Jun 22, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Adenoma

    Study Results

    No Results Posted as of Jun 22, 2023