Crohn DiseaseNCT05161442
Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic
An observational study of Crohn Disease and Surgery, run by Mayo Clinic.
Trial summary
Retrospective observational cohort study including patients with Crohn's Disease undergoing minimally invasive ileocolic resection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn Disease, Surgery
- How many people
- 249 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospective cohort of patients with Crohn underwent ileocolic resection.
Who may be able to join
- Crohn's disease
- Ileocolic resection
Who cannot join
- N/A
About this study
Retrospective observational cohort study including patients with Crohn's Disease undergoing minimally invasive ileocolic resection.
Read the 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.
- Conditions
- Crohn Disease, Surgery
- Keywords
- crohn disease, minimally invasive surgery, ileocolic resection, outcomes, complication, enhanced recovery after surgery
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
conversion
intraoperative conversion to open (yes/no)
Measured: 30-day after surgery
postoperative complications
30-day postoperative complications described as binary variable (yes/no) and type.
Measured: 30-day after surgery
postoperative complications grade
30-day postoperative complications graded according Clavien-Dindo classification (I-V).
Measured: 30-day after surgery
length of hospital stay
length of hospital stay (days)
Measured: 30-day after surgery
hospital readmission
30-day hospital readmission (yes/no)
Measured: 30-day after surgery
Secondary outcomes (4)
Recurrence date
Endoscopic recurrence (date)
Measured: 5 years
Recurrence grade
Endoscopic recurrence (Rutgeerts)
Measured: 5 years
Recurrence clinical
Clinical recurrence (yes/no)
Measured: 5 years
Gastrointestinal Quality of Life Index
quality of life measured according to Gastrointestinal Quality of Life Index (GIQLI)
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study startJan 2014
- Primary completion31 Dec 2021
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David W. Larson, Mayo Clinic
- Investigators
- David W Larson, MD,MBA, Principal investigator, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161442
- Sponsor's protocol ID
- 21-002141
- Status last verified
- Mar 2024
- First submitted
- 11 Oct 2021
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to third part, according to the condition indicated in the IRB.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic
- ClinicalTrials.gov ID
- NCT05161442
- Acronym / sponsor ID
- 21-002141
- Conditions
- Crohn Disease, Surgery
- Keywords
- crohn disease, minimally invasive surgery, ileocolic resection, outcomes, complication, enhanced recovery after surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective observational cohort study including patients with Crohn's Disease undergoing minimally invasive ileocolic resection.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective cohort of patients with Crohn underwent ileocolic resection.
Key inclusion criteria (2 listed)
- Crohn's disease
- Ileocolic resection
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
conversion
Time frame: 30-day after surgery
intraoperative conversion to open (yes/no)
postoperative complications
Time frame: 30-day after surgery
30-day postoperative complications described as binary variable (yes/no) and type.
postoperative complications grade
Time frame: 30-day after surgery
30-day postoperative complications graded according Clavien-Dindo classification (I-V).
length of hospital stay
Time frame: 30-day after surgery
length of hospital stay (days)
hospital readmission
Time frame: 30-day after surgery
30-day hospital readmission (yes/no)
4 secondary outcomes
Recurrence date
Time frame: 5 years
Recurrence grade
Time frame: 5 years
Recurrence clinical
Time frame: 5 years
Gastrointestinal Quality of Life Index
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared to third part, according to the condition indicated in the IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Larson, MD,MBA principal investigator
Mayo Clinic, Rochester, MN
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Surgery, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
conversion (time frame: 30-day after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.