Right ColectomyRIGHTCOLOCALCINCT04002921
Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy
An observational study of Right Colectomy, run by Centre Hospitalier Departemental Vendee at 12 sites in France.
Trial summary
Anastomotic leakage is the major postoperative complication in right colectomy. Evaluation of calcification on coeliac trunk and mesenteric arteries on the preoperative CT scan could allow the identification of patient at-risk of postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Colectomy
- How many people
- 615 participants
- Where
- 12 sitesFrance
- Study dates
- 24 Sep 2019to 18 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient admitted for right colectomy in one of the 6 hospitals or clinics.
Who may be able to join
- Age ≥ 18 years old
- Scheduled right colectomy with restoration of digestive continuity
- Patient who has had or will have a preoperative abdominal-pelvic CT scan with or without contrast injection
- Patient with the ability to understand the protocol and agree to participate in the study.
- Affiliated with a social security system
Who cannot join
- Patient requiring a right colectomy or ileocaecal resection for chronic inflammatory bowel disease or on long-term corticosteroid therapy
- Patient with a history of colic resection
- Patient under guardianship, curatorship, or deprived of liberty
- Pregnant, postpartum or breastfeeding women
- Minor patients
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU Angers
Angers
Hopital privé de Sévigné
Cesson-Sévigné
CH de Challans
Challans, 85300
CH de Cholet 1 rue Marengo
Cholet, 49300
Centre Hospitalier de Fougères
Fougères, 35300
CHD Vendée
La Roche-sur-Yon, 85925
Centre Hospitalier du Mans
Le Mans
Clinique Mutualiste de la Porte de l'Orient
Lorient, 56324
CHU de Nantes
Nantes, 44093
Centre Hospitalier de Saint Brieuc
Saint-Brieuc
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44600
Centre Hospitalier Bretagne Atlantique
Vannes, 56017
About this study
Anastomotic leakage is the major postoperative complication in right colectomy. Evaluation of calcification on coeliac trunk and mesenteric arteries on the preoperative CT scan could allow the identification of patient at-risk of postoperative complications.
A monocentric retrospective study performed at CHD Vendée concluded than a calcification score over or equal to 3 was associated with a higher risk of developping an anastomotic leakage.
The aim of this prospective multicentric study is to validate a calcification score based on preoperative CT scan analysis and focussing at coeliac trunk and mesenteric arteries.This study will involve patients operated on with a scheduled right colectomy.
- Conditions
- Right Colectomy
- Keywords
- right colectomy, calcification, anastomotic leakage
- Medical subject headings
- Calcinosis, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Right colectomy | Patient with scheduled right colectomy and with a documented preoperative scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total calcification score associated with the occurrence of anastomotic leakage
Sum of the calcification scores of the following 4 segments (≥3) associated with the occurrence of anastomotic leakage within 6 weeks postoperatively.
4 segments:
- Ostium of celiac artery
- Ostium of superior mesenteric artery
- first segment of superior mesenteric artery
- distal segment of superior mesenteric artery Each segment will be assigned a score between 0 and 2. Total score range : 0-8
Measured: 6 weeks after surgery
Secondary outcomes (2)
Calcification score of each segment associated with the occurrence of anastomotic leakage
4 segments:
- Ostium of celiac artery
- Ostium of superior mesenteric artery
- first segment of superior mesenteric artery
- distal segment of superior mesenteric artery Each segment will be assigned a score between 0 and 2.
Measured: 6 weeks after surgery
Morbidities defined according to Clavien-Dindo classification
Morbidities defined according to Clavien-Dindo classification occurring at 6 weeks postoperatively
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start24 Sep 2019
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right ColectomyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emeric ABET, Principal investigator, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002921
- Sponsor's protocol ID
- CHD 086-19
- Acronym
- RIGHTCOLOCALCI
- Status last verified
- Nov 2025
- First submitted
- 27 Jun 2019
- Last updated
- 4 Dec 2025
- 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 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy
- ClinicalTrials.gov ID
- NCT04002921
- Acronym / sponsor ID
- RIGHTCOLOCALCI / CHD 086-19
- Conditions
- Right Colectomy
- Keywords
- right colectomy, calcification, anastomotic leakage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 1 Jul 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.
Anastomotic leakage is the major postoperative complication in right colectomy. Evaluation of calcification on coeliac trunk and mesenteric arteries on the preoperative CT scan could allow the identification of patient at-risk of postoperative complications.
A monocentric retrospective study performed at CHD Vendée concluded than a calcification score over or equal to 3 was associated with a higher risk of developping an anastomotic leakage.
The aim of this prospective multicentric study is to validate a calcification score based on preoperative CT scan analysis and focussing at coeliac trunk and mesenteric arteries.This study will involve patients operated on with a scheduled right colectomy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Right colectomy | – | –Patient with scheduled right colectomy and with a documented preoperative scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted for right colectomy in one of the 6 hospitals or clinics.
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Scheduled right colectomy with restoration of digestive continuity
- Patient who has had or will have a preoperative abdominal-pelvic CT scan with or without contrast injection
- Patient with the ability to understand the protocol and agree to participate in the study.
- Affiliated with a social security system
Key exclusion criteria (5 listed)
- Patient requiring a right colectomy or ileocaecal resection for chronic inflammatory bowel disease or on long-term corticosteroid therapy
- Patient with a history of colic resection
- Patient under guardianship, curatorship, or deprived of liberty
- Pregnant, postpartum or breastfeeding women
- Minor patients
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
Total calcification score associated with the occurrence of anastomotic leakage
Time frame: 6 weeks after surgery
Sum of the calcification scores of the following 4 segments (≥3) associated with the occurrence of anastomotic leakage within 6 weeks postoperatively. 4 segments: * Ostium of celiac artery * Ostium of superior mesenteric artery * first segment of superior mesenteric artery * distal segment of superior mesenteric artery Each segment will be assigned a score between 0 and 2. Total score range : 0-8
2 secondary outcomes
Calcification score of each segment associated with the occurrence of anastomotic leakage
Time frame: 6 weeks after surgery
Morbidities defined according to Clavien-Dindo classification
Time frame: 6 weeks 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 4 Dec 2025.
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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.
Emeric ABET principal investigator
CHD Vendée
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Colectomy, run by Centre Hospitalier Departemental Vendee at 12 sites 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 5 inclusion and 5 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 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Total calcification score associated with the occurrence of anastomotic leakage (time frame: 6 weeks 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 4 Dec 2025.