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Multiple Firings in Double-stapled Colorectal Anastomosis

Sponsor
Shanghai Minimally Invasive Surgery Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05498506
Collaborator
(none)
350
Enrollment
4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Multiple linear stapler firings during double stapling technique (DST) is associated with anastomotic leakage (AL) after laparoscopic low anterior resection (LAR). We aim to investigate the risk factors and then to develop a deep learning model to predict the usage of ≥3 linear stapler cartridges during DST anastomosis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    350 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Risk Factors for the Usage of ≥3 Linear Stapler Cartridges During Double Stapling Anastomosis in Laparoscopic Low Anterior Resection of Rectal Cancer
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. the number of linear stapler cartridges [during surgery]

      the number of linear stapler cartridges used during DST anastomosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. carcinoma of rectum confirmed by histopathological evaluation;
      1. tumor located in the mid-low rectum (less than 10cm from the anal verge);
      1. performance of DST anastomosis;
      1. pelvic MRI obtained within 14 days before surgery.
    Exclusion Criteria:
      1. other anastomotic techniques (e.g., trans-anal rectal excision);
      1. Hartmann's operation or other procedures without anastomosis;
      1. the number of linear stapler cartridges was not traceable in the operative report.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shanghai Minimally Invasive Surgery Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cai Zhenghao, Director, department of medical-engineering collaboration, Shanghai Minimally Invasive Surgery Center
    ClinicalTrials.gov Identifier:
    NCT05498506
    Other Study ID Numbers:
    • MISC-DST
    First Posted:
    Aug 12, 2022
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Aug 15, 2022