Left Elective ColectomyLECoRTNCT04495023
Left Elective Colectomy in Renal Transplanted Patients
An observational study of Left Elective Colectomy and Renal Transplanted Patients, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Aim of the study : To evaluate postoperative outcomes of elective left-sided colectomy in a renal transplanted population. Methods : From 2010 to 2015, all consecutive patients who underwent left elective colectomy in a referral center were prospectively collected. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Left Elective Colectomy, Renal Transplanted Patients
- What is being tested?
- Left elective colectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Apr 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: Patients who Open or laparoscopic left elective colectomy with colo-rectal anastomosis
Who may be able to join
- Open or laparoscopic left elective colectomy with colo-rectal anastomosis
- age > 18 y.o.
Who cannot join
- emergency surgery
- past history of rectal surgery
- ASA I
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Left Elective Colectomy in Renal Transplanted Patients : a Case-control Study (LECoRT Study)
Aim of the study :
To evaluate postoperative outcomes of elective left-sided colectomy in a renal transplanted population.
Methods :
From 2010 to 2015, all consecutive patients who underwent left elective colectomy in a referral center were prospectively collected.
Considering our exclusion criterial, data from 120 patients were analyzed. The cohort was separated into 2 groups : renal transplanted patients (KTR-group) and non-renal transplanted patients (C-group) Short and longterm outcomes were compared between the two groups.
Primary outcome :
90 days postoperative anastomotic leak rate
Read the detailed description
From January 2010 to December 2015, data from patients requiring an elective left colectomy for benign or malignant indication were collected prospectively in our colorectal surgery database.
According to our exclusion criterial patients were retrospectively divided into two groups: kidney transplant recipients (KTR-group) and control group (C-group).
The surgical indication for an oncologic left colectomy was retained by the expert surgeon, after a multidisciplinary conversation meeting comprising at least one surgeon, one gastroenterologist, one nephrologist, one radiologist and one oncologist. The surgical indication for diverticular disease was based on French guidelines.
Demographic, clinical, intraoperative and postoperative, histological, length of hospital stay and mortality data were collected over a 90-day period following the intervention.
- Being tested
- Left elective colectomy
- Keywords
- Benign or malign pathology, Renal transplanted patients, Anastomotic leakage
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left elective colectomyProcedure or surgery
Open or laparoscopic left elective colectomy with colo-rectal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Kidney transplanted patients) | Group 1: Kidney transplanted patients requiring oncologic or non-oncologic left elective colectomy All kidney transplanted patients requiring oncologic or non-oncologic left elective colectomy between 01 January 2004 and 31 December 2015. Receives: Procedure: Left elective colectomy | |
| Group 2 (Non-transplanted patients) | Group 2 : Non-transplanted patients requiring oncologic or non-oncologic left elective colectomy Non-transplanted patients requiring oncologic or non-oncologic left elective colectomy between 01 January 2004 and 31 December 2015. Receives: Procedure: Left elective colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Anastomotic leak after left elective colectomy
Anastomotic leak according to the International Study Group of Rectal Cancer
Measured: 90 days postoperative
Secondary outcomes (1)
Long term outcomes
Status at the date of latest news
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Jan 2020
- Primary completion30 Jan 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Elective 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Visceral and Digestive Surgery, Centre hospitalier de Dunkerque
- Responsible party
- Sponsor
- Investigators
- REGIS SOUCHE, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495023
- Sponsor's protocol ID
- RECHMPL20_0356
- Acronym
- LECoRT
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Bardol T, Souche R, Genet D, Ferrandis C, Guillon F, Pirlet I, Fabre JM. Outcomes of elective left colectomy in renal-transplanted patients: a single-center case-control study (LECoRT study). Int J Colorectal Dis. 2021 Jun;36(6):1209-1219. doi: 10.1007/s00384-021-03860-7. Epub 2021 Jan 28.
PubMed 33511479
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Elective Colectomy in Renal Transplanted Patients : a Case-control Study (LECoRT Study)
- ClinicalTrials.gov ID
- NCT04495023
- Acronym / sponsor ID
- LECoRT / RECHMPL20_0356
- Keywords
- Benign or malign pathology, Renal transplanted patients, Anastomotic leakage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Department of Visceral and Digestive Surgery, Centre hospitalier de Dunkerque
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 31 Jul 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 of the study :
To evaluate postoperative outcomes of elective left-sided colectomy in a renal transplanted population.
Methods :
From 2010 to 2015, all consecutive patients who underwent left elective colectomy in a referral center were prospectively collected.
Considering our exclusion criterial, data from 120 patients were analyzed. The cohort was separated into 2 groups : renal transplanted patients (KTR-group) and non-renal transplanted patients (C-group) Short and longterm outcomes were compared between the two groups.
Primary outcome :
90 days postoperative anastomotic leak rate
Detailed description
From January 2010 to December 2015, data from patients requiring an elective left colectomy for benign or malignant indication were collected prospectively in our colorectal surgery database.
According to our exclusion criterial patients were retrospectively divided into two groups: kidney transplant recipients (KTR-group) and control group (C-group).
The surgical indication for an oncologic left colectomy was retained by the expert surgeon, after a multidisciplinary conversation meeting comprising at least one surgeon, one gastroenterologist, one nephrologist, one radiologist and one oncologist. The surgical indication for diverticular disease was based on French guidelines.
Demographic, clinical, intraoperative and postoperative, histological, length of hospital stay and mortality data were collected over a 90-day period following the intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Kidney transplanted patients) | – | Procedure: Left elective colectomyGroup 1: Kidney transplanted patients requiring oncologic or non-oncologic left elective colectomy All kidney transplanted patients requiring oncologic or non-oncologic left elective colectomy between 01 January 2004 and 31 December 2015. |
| Group 2 (Non-transplanted patients) | – | Procedure: Left elective colectomyGroup 2 : Non-transplanted patients requiring oncologic or non-oncologic left elective colectomy Non-transplanted patients requiring oncologic or non-oncologic left elective colectomy between 01 January 2004 and 31 December 2015. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who Open or laparoscopic left elective colectomy with colo-rectal anastomosis
Key inclusion criteria (2 listed)
- Open or laparoscopic left elective colectomy with colo-rectal anastomosis
- age > 18 y.o.
Key exclusion criteria (3 listed)
- emergency surgery
- past history of rectal surgery
- ASA I
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 |
|---|---|---|
| Left elective colectomyOpen or laparoscopic left elective colectomy with colo-rectal anastomosis | Procedure or surgery | Group 1 (Kidney transplanted patients), Group 2 (Non-transplanted patients) |
Primary outcome
Rate of Anastomotic leak after left elective colectomy
Time frame: 90 days postoperative
Anastomotic leak according to the International Study Group of Rectal Cancer
1 secondary outcome
Long term outcomes
Time frame: 1 day
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 3 Sep 2020.
- Derived from this study: PubMed 33511479Bardol T, Souche R, Genet D, Ferrandis C, Guillon F, Pirlet I, Fabre JM. Outcomes of elective left colectomy in renal-transplanted patients: a single-center case-control study (LECoRT study). Int J Colorectal Dis. 2021 Jun;36(6):1209-1219. doi: 10.1007/s00384-021-03860-7. Epub 2021 Jan 28.
- Individual participant dataSharing planned: Undecided. NC
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 Left Elective Colectomy and Renal Transplanted Patients, 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 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 3 Sep 2020. 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 Anastomotic leak after left elective colectomy (time frame: 90 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04495023, which also lists 1 linked publication.
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 3 Sep 2020.