Clinical trial NCT04495023: Left Elective Colectomy in Renal Transplanted Patients
Official title: Left Elective Colectomy in Renal Transplanted Patients : a Case-control Study (LECoRT Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Elective Colectomy
Renal Transplanted Patients
Keywords: Benign or malign pathology
Renal transplanted patients
Anastomotic leakage
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Department of Visceral and Digestive Surgery, Centre hospitalier de Dunkerque
First posted: 2020-07-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who Open or laparoscopic left elective colectomy with colo-rectal anastomosis

Brief 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.

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.

Eligibility criteria: Inclusion criteria:

* Open or laparoscopic left elective colectomy with colo-rectal anastomosis
* age \> 18 y.o.

Exclusion criteria:

* emergency surgery
* past history of rectal surgery
* ASA I

Primary outcomes:
measure: Rate of Anastomotic leak after left elective colectomy
timeFrame: 90 days postoperative
Secondary outcomes:
measure: Long term outcomes
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: REGIS SOUCHE
role: STUDY_DIRECTOR
References:
citation: 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.