Left Elective Colectomy in Renal Transplanted Patients (LECoRT)

September 1, 2020 updated by: University Hospital, Montpellier

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who Open or laparoscopic left elective colectomy with colo-rectal anastomosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Left elective colectomy
Open or laparoscopic left elective colectomy with colo-rectal anastomosis
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.
Procedure: Left elective colectomy
Open or laparoscopic left elective colectomy with colo-rectal anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Anastomotic leak after left elective colectomy
Time Frame: 90 days postoperative
Anastomotic leak according to the International Study Group of Rectal Cancer
90 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term outcomes
Time Frame: 1 day
Status at the date of latest news
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Department of Visceral and Digestive Surgery, Centre hospitalier de Dunkerque

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 30, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 31, 2020

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL20_0356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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