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Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05161442
Collaborator
(none)
354
Enrollment
106
Duration (Months)

Study Details

Study Description

Brief Summary

Retrospective observational cohort study including patients with Crohn's Disease undergoing minimally invasive ileocolic resection.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All consecutive patients with Crohn's disease (CD) who underwent minimally invasive ileocolic resection from 2014 at Mayo Clinic were retrospectively identified using a prospectively maintained institutional database.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    354 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Nov 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. conversion [30-day after surgery]

      intraoperative conversion to open (yes/no)

    2. postoperative complications [30-day after surgery]

      30-day postoperative complications described as binary variable (yes/no) and type.

    3. postoperative complications grade [30-day after surgery]

      30-day postoperative complications graded according Clavien-Dindo classification (I-V).

    4. length of hospital stay [30-day after surgery]

      length of hospital stay (days)

    5. hospital readmission [30-day after surgery]

      30-day hospital readmission (yes/no)

    Secondary Outcome Measures

    1. Recurrence date [5 years]

      Endoscopic recurrence (date)

    2. Recurrence grade [5 years]

      Endoscopic recurrence (Rutgeerts)

    3. Recurrence clinical [5 years]

      Clinical recurrence (yes/no)

    4. Gastrointestinal Quality of Life Index [7 years]

      quality of life measured according to Gastrointestinal Quality of Life Index (GIQLI)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Crohn's disease

    • Ileocolic resection

    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: David W Larson, MD,MBA, Mayo Clinic, Rochester, MN

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    David W. Larson, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05161442
    Other Study ID Numbers:
    • 21-002141
    First Posted:
    Dec 17, 2021
    Last Update Posted:
    Feb 23, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by David W. Larson, Principal Investigator, Mayo Clinic
    crohn disease
    minimally invasive surgery
    ileocolic resection
    outcomes
    complication
    enhanced recovery after surgery
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of Feb 23, 2022