Crohn Disease of IleumNCT03950726
Ileocolic Resection for Complex Crohn's Disease
An observational study of Crohn Disease of Ileum, run by University of Roma La Sapienza.
Trial summary
Laparoscopic ileocolic resection is the preferred surgical approach for patients with ileocecal Crohn's disease (CD). Objective of this study was to evaluate the efficacy of a minimally invasive gas-less ileocolic resection in complex cases of CD through a Mc Burney incision, in patients who already had a previous… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn Disease of Ileum
- What is being tested?
- ileocolic resection
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 4 May 2019
- 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: Any patient with complex terminal ileum Crohn's disease candidate for ileocolic resection who underwent to previous open appendectomy.
Who may be able to join
- diagnosed Crohn's disease
- previous appendectomy trough a mcburney incision
Who cannot join
- patients with major comorbidities
- age>75
- previous midline laparotomy
About this study
Official title: Minimally Invasive Open Technique for Ileo-colic Resection in Complex Cases of Terminal Ileum Crohn's Disease. Case Series.
Laparoscopic ileocolic resection is the preferred surgical approach for patients with ileocecal Crohn's disease (CD). Objective of this study was to evaluate the efficacy of a minimally invasive gas-less ileocolic resection in complex cases of CD through a Mc Burney incision, in patients who already had a previous appendectomy.
Read the detailed description
From January 2016 to December 2017, all consecutive CD patients with primary or recurrent complex disease referred for IC resection were evaluated for the study purpose.Complex disease patients presenting McBurney incision for a previous open appendectomy were included in the group of study. This group was compared with a control group of CD patients with the same clinical characteristics of ileocolic disease who underwent standard laparoscopic IC resection, pooled out from the database of IC resections for CD of the Minimally Invasive and Gastrointestinal Surgery Unit of Tor Vergata Hospital, Rome, Italy. Data on demographics, BMI, type and behavior of CD, presence of disease apart from ileocecal site, previous surgery, recurrence, current medical treatment, thickening of the mesentery, preoperative imaging results (MR enterography or small intestine contrast ultrasound), operative time, blood loss, conversion to laparoscopy and conversion to open rates, complications, adherence rate to ERAS protocols and length of hospital stay were collected for the study purpose.
- Conditions
- Crohn Disease of Ileum
- Being tested
- ileocolic resection
- Keywords
- Crohn Disease, Ileocolic resection, Appendectomy, Single-port incision, McBurney, Laparoscopy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ileocolic resectionProcedure or surgery
Ileocolic resection through McBurney incision
| Study group | Role | What they receive |
|---|---|---|
| Study Group | patients with complex crohn's disease who had a previous open appendectomy through a mc burney incision scheduled for ileo-colic resection through the same incision Receives: Procedure: ileocolic resection | |
| Control Group | patients with complex crohn's disease who had a previous open appendectomy through a mc burney incision scheduled for ileo-colic resection who underwent standard laparoscopic resection Receives: Procedure: ileocolic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean operative time
duration of surgical procedure
Measured: 75-156 minutes
Mean blood loss during surgical procedure
blood loss from the beginning to the end of the procedure
Measured: 2 hours
Mean post-operative hospital stay
time from day of surgery to discharge
Measured: 3-7 days
Secondary outcomes (1)
post-operative complications
complications according to Clavien Dindo classification
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion4 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease of IleumStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, simone sibio, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950726
- Sponsor's protocol ID
- Chirurgia Mini-invasiva PTV
- Status last verified
- May 2019
- First submitted
- 7 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Open Technique for Ileo-colic Resection in Complex Cases of Terminal Ileum Crohn's Disease. Case Series.
- ClinicalTrials.gov ID
- NCT03950726
- Acronym / sponsor ID
- Chirurgia Mini-invasiva PTV
- Conditions
- Crohn Disease of Ileum
- Keywords
- Crohn Disease, Ileocolic resection, Appendectomy, Single-port incision, McBurney, Laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 4 May 2019 (actual)
- First posted
- 15 May 2019 (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.
Laparoscopic ileocolic resection is the preferred surgical approach for patients with ileocecal Crohn's disease (CD). Objective of this study was to evaluate the efficacy of a minimally invasive gas-less ileocolic resection in complex cases of CD through a Mc Burney incision, in patients who already had a previous appendectomy.
Detailed description
From January 2016 to December 2017, all consecutive CD patients with primary or recurrent complex disease referred for IC resection were evaluated for the study purpose.Complex disease patients presenting McBurney incision for a previous open appendectomy were included in the group of study. This group was compared with a control group of CD patients with the same clinical characteristics of ileocolic disease who underwent standard laparoscopic IC resection, pooled out from the database of IC resections for CD of the Minimally Invasive and Gastrointestinal Surgery Unit of Tor Vergata Hospital, Rome, Italy. Data on demographics, BMI, type and behavior of CD, presence of disease apart from ileocecal site, previous surgery, recurrence, current medical treatment, thickening of the mesentery, preoperative imaging results (MR enterography or small intestine contrast ultrasound), operative time, blood loss, conversion to laparoscopy and conversion to open rates, complications, adherence rate to ERAS protocols and length of hospital stay were collected for the study purpose.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Procedure: ileocolic resectionpatients with complex crohn's disease who had a previous open appendectomy through a mc burney incision scheduled for ileo-colic resection through the same incision |
| Control Group | – | Procedure: ileocolic resectionpatients with complex crohn's disease who had a previous open appendectomy through a mc burney incision scheduled for ileo-colic resection who underwent standard laparoscopic resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient with complex terminal ileum Crohn's disease candidate for ileocolic resection who underwent to previous open appendectomy.
Key inclusion criteria (2 listed)
- diagnosed Crohn's disease
- previous appendectomy trough a mcburney incision
Key exclusion criteria (3 listed)
- patients with major comorbidities
- age>75
- previous midline laparotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ileocolic resectionIleocolic resection through McBurney incision | Procedure or surgery | Control Group, Study Group |
Primary outcome
Mean operative time
Time frame: 75-156 minutes
duration of surgical procedure
Mean blood loss during surgical procedure
Time frame: 2 hours
blood loss from the beginning to the end of the procedure
Mean post-operative hospital stay
Time frame: 3-7 days
time from day of surgery to discharge
1 secondary outcome
post-operative complications
Time frame: 30 days
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 15 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease of Ileum, run by University of Roma La Sapienza.
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 3 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 15 May 2019. 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?
Mean operative time (time frame: 75-156 minutes). The study lists 3 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 15 May 2019.