Left Elective Colectomy in Renal Transplanted Patients

Left Elective Colectomy Clinical Trial

— LECoRT  

Official title:

Left Elective Colectomy in Renal Transplanted Patients : a Case-control Study (LECoRT Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495023
• Other study ID #: RECHMPL20_0356
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 1, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Left Elective Colectomy
• Renal Transplanted Patients

Intervention

Procedure:
• Left elective colectomy
Open or laparoscopic left elective colectomy with colo-rectal anastomosis

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Department of Visceral and Digestive Surgery, Centre hospitalier de Dunkerque

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Anastomotic leak after left elective colectomy	Anastomotic leak according to the International Study Group of Rectal Cancer	90 days postoperative
Secondary	Long term outcomes	Status at the date of latest news	1 day