Crohn DiseaseC-ICR-CDNCT04643496
CRP Monitoring After ICR in CD Patients
An observational study of Crohn Disease and Ileocolic Resection, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Aim: The aim of this study was to assess the accuracy of the C-reactive protein as an early predictor of intra-abdominal septic complicationss after ileocolic resection for Crohn disease. Methods: Data collected between January 2010 and March 2020 will be analyzed. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Crohn Disease, Ileocolic Resection
- What is being tested?
- Laparoscopic or open Ileocolic resection
- Type of treatment
- Surgery or procedure
- How many people
- 159 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2010to 1 Sep 2020
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective review of collected data including all consecutive patients requiring an ileocolic resection for Crohn disease between January 2010 and March 2020 at the Digestive Surgery Units of CHU Montpellier.
Who may be able to join
- Patients who underwent an ileocolic resection for Crohn disease
- Patient ≥18 years old
Who cannot join
- Patient who reject the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-operative CRP Monitoring After Ileo-colic Resection in Crohn's Disease Patients
Aim: The aim of this study was to assess the accuracy of the C-reactive protein as an early predictor of intra-abdominal septic complicationss after ileocolic resection for Crohn disease.
Methods: Data collected between January 2010 and March 2020 will be analyzed. Informations about preoperative, peroperative and post operative will be collected. The outcome after surgery will be analysed according to the comprehensive complication index.
Read the detailed description
In colorectal surgery, inflammatory markers (CRP, PCT) are used systematically in the postoperative period as an early predictor of postoperative complications and in particular the prediction of anastomotic leaks and intra-abdominal septic complications.
Indeed, the occurrence of an anastomotic leak (5 to 15% of cases) involves the introduction of antibiotics, the carrying out of invasive procedures which can go as far as reoperation (and the establishment of ostomy) and always increases the length of stay and the cost of hospitalization. It is therefore essential to benefit from the most sensitive and specific tools to detect this serious and sometimes lethal complication at an early stage.
Numerous studies have evaluated and demonstrated the value of monitoring the CRP in the early postoperative period to detect the occurrence of an anastomotic leak. However, the majority of these studies presented heterogeneous populations for two reasons: all types of colorectal surgery interventions were included (right colectomy, transverse colectomy, left colectomy and anterior resection of the rectum) and multiple surgical indications were taken into account (colorectal cancer, inflammatory bowel disease, colonic diverticulosis).
In addition, a 2015 study comparing the postoperative monitoring of markers of inflammation after ileocolic resection of patients with, on the one hand, Crohn's disease and, on the other, colon cancer showed a greater inflammatory reaction in patients with Crohn's disease (in particular on POD1, 4, 5 and 6) without identifying a threshold value. This increased inflammatory response can be explained by a greater inflammatory state than in the general population: bacterial translocation due to an alteration of the mucosal barrier aggravated by immunodeficiency.
It thus appears that the cut-off values usually used (170-175 mg/l on POD3 and 125mg/l on POD4) are probably not suitable for the postoperative monitoring of these patients and for prediction of intra-abdominal septic complications.
No study to date has identified a threshold value of postoperative CRP that can predict the occurrence of postoperative anastomotic fistula and intra-abdominal septic complications after ileocecal resection for Crohn's disease.
- Conditions
- Crohn Disease, Ileocolic Resection
- Being tested
- Laparoscopic or open Ileocolic resection
- Keywords
- Laparoscopy, C-reactive protein, Postoperative outcomes, Intra-abdominal septic complications
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic or open Ileocolic resectionProcedure or surgery
Laparoscopic or open Ileocolic resection
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring ileocolic resection for Crohn disease. | All consecutive patients requiring an ileocolic resection for Crohn disease, between January 2010 and March 2020 at the Digestive Surgery Units of CHU Montpellier. Receives: Procedure: Laparoscopic or open Ileocolic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of intra-abdominal septic complications
Rate of intra-abdominal septic complications
Measured: 90 days (after surgery)
Secondary outcomes (7)
Anastomotic leak rate
Anastomotic leak rate
Measured: 90 days (after surgery)
Rate ofMorb idity according to the Clavien Dindo Classification
Morbidity according to the Clavien Dindo Classification
Measured: 90 days (after surgery)
Rate of Mortality
Mortality
Measured: 90 days (after surgery)
Number of Participants with Hemorragic complications
Hemorragic complications
Measured: 90 days (after surgery)
Reoperation rate
Reoperation rate
Measured: 90 days (after surgery)
Post-operative rate of stomy
Post-operative rate of stomy
Measured: 90 days (after surgery)
Readmission rate
Readmission rate
Measured: 90 days (after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Jan 2010
- Primary completion1 Mar 2020
- Study completion1 Sep 2020
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 University Hospital, MontpellierThe 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- REGIS SOUCHE, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643496
- Sponsor's protocol ID
- RECHMPL20_0632
- Acronym
- C-ICR-CD
- Status last verified
- Nov 2020
- First submitted
- 19 Nov 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative CRP Monitoring After Ileo-colic Resection in Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT04643496
- Acronym / sponsor ID
- C-ICR-CD / RECHMPL20_0632
- Conditions
- Crohn Disease, Ileocolic Resection
- Keywords
- Laparoscopy, C-reactive protein, Postoperative outcomes, Intra-abdominal septic complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 25 Nov 2020 (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.
Aim: The aim of this study was to assess the accuracy of the C-reactive protein as an early predictor of intra-abdominal septic complicationss after ileocolic resection for Crohn disease.
Methods: Data collected between January 2010 and March 2020 will be analyzed. Informations about preoperative, peroperative and post operative will be collected. The outcome after surgery will be analysed according to the comprehensive complication index.
Detailed description
In colorectal surgery, inflammatory markers (CRP, PCT) are used systematically in the postoperative period as an early predictor of postoperative complications and in particular the prediction of anastomotic leaks and intra-abdominal septic complications.
Indeed, the occurrence of an anastomotic leak (5 to 15% of cases) involves the introduction of antibiotics, the carrying out of invasive procedures which can go as far as reoperation (and the establishment of ostomy) and always increases the length of stay and the cost of hospitalization. It is therefore essential to benefit from the most sensitive and specific tools to detect this serious and sometimes lethal complication at an early stage.
Numerous studies have evaluated and demonstrated the value of monitoring the CRP in the early postoperative period to detect the occurrence of an anastomotic leak. However, the majority of these studies presented heterogeneous populations for two reasons: all types of colorectal surgery interventions were included (right colectomy, transverse colectomy, left colectomy and anterior resection of the rectum) and multiple surgical indications were taken into account (colorectal cancer, inflammatory bowel disease, colonic diverticulosis).
In addition, a 2015 study comparing the postoperative monitoring of markers of inflammation after ileocolic resection of patients with, on the one hand, Crohn's disease and, on the other, colon cancer showed a greater inflammatory reaction in patients with Crohn's disease (in particular on POD1, 4, 5 and 6) without identifying a threshold value. This increased inflammatory response can be explained by a greater inflammatory state than in the general population: bacterial translocation due to an alteration of the mucosal barrier aggravated by immunodeficiency.
It thus appears that the cut-off values usually used (170-175 mg/l on POD3 and 125mg/l on POD4) are probably not suitable for the postoperative monitoring of these patients and for prediction of intra-abdominal septic complications.
No study to date has identified a threshold value of postoperative CRP that can predict the occurrence of postoperative anastomotic fistula and intra-abdominal septic complications after ileocecal resection for Crohn's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring ileocolic resection for Crohn disease. | – | Procedure: Laparoscopic or open Ileocolic resectionAll consecutive patients requiring an ileocolic resection for Crohn disease, between January 2010 and March 2020 at the Digestive Surgery Units of CHU Montpellier. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective review of collected data including all consecutive patients requiring an ileocolic resection for Crohn disease between January 2010 and March 2020 at the Digestive Surgery Units of CHU Montpellier.
Key inclusion criteria (2 listed)
- Patients who underwent an ileocolic resection for Crohn disease
- Patient ≥18 years old
Key exclusion criteria (1 listed)
- Patient who reject the study protocol
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 |
|---|---|---|
| Laparoscopic or open Ileocolic resectionLaparoscopic or open Ileocolic resection | Procedure or surgery | Patients requiring ileocolic resection for Crohn disease. |
Primary outcome
Rate of intra-abdominal septic complications
Time frame: 90 days (after surgery)
Rate of intra-abdominal septic complications
7 secondary outcomes
Anastomotic leak rate
Time frame: 90 days (after surgery)
Rate ofMorb idity according to the Clavien Dindo Classification
Time frame: 90 days (after surgery)
Rate of Mortality
Time frame: 90 days (after surgery)
Number of Participants with Hemorragic complications
Time frame: 90 days (after surgery)
Reoperation rate
Time frame: 90 days (after surgery)
Post-operative rate of stomy
Time frame: 90 days (after surgery)
Readmission rate
Time frame: 90 days (after surgery)
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 Feb 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
REGIS SOUCHE study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Ileocolic Resection, run by University Hospital, Montpellier at 1 site in France.
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 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Rate of intra-abdominal septic complications (time frame: 90 days (after surgery)). 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 Feb 2021.