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OpenTrials
Completed

NCT Number: NCT05161442

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

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

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Surgery

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Crohn's disease
  • Ileocolic resection

Exclusion criteria

  • N/A

Treatment and study plan

Primary outcomes

  1. conversion

    Time frame: 30-day after surgery

    intraoperative conversion to open (yes/no)

  2. postoperative complications

    Time frame: 30-day after surgery

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

  3. postoperative complications grade

    Time frame: 30-day after surgery

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

  4. length of hospital stay

    Time frame: 30-day after surgery

    length of hospital stay (days)

  5. hospital readmission

    Time frame: 30-day after surgery

    30-day hospital readmission (yes/no)

Secondary outcomes

  1. Recurrence date

    Time frame: 5 years

    Endoscopic recurrence (date)

  2. Recurrence grade

    Time frame: 5 years

    Endoscopic recurrence (Rutgeerts)

  3. Recurrence clinical

    Time frame: 5 years

    Clinical recurrence (yes/no)

  4. Gastrointestinal Quality of Life Index

    Time frame: 7 years

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2023
First posted
Dec 17, 2021
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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