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

Overview

Aim of the study :

To evaluate the impact of renal trasplantation on the post operative outcomes of left elective colectomy

Methods :

Patients who underwent oncologic or non-oncologic left elective colectomy between 01 January 2004 and 31 December 2015.

Case-control study. Evaluation of the post operative anastomotic leak rate.

Primary outcome :

Anastomotic leakage (AL)

Full Title of Study: “Left Elective Colectomy in Renal Transplanted Patients : a Case-control Study LECoRT”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: January 30, 2020

Detailed Description

Left-sided colectomy is a frequent surgical procedure done over the last decades. Anastomotic leakage (AL) is a frequent, sometimes life-threatening, but not predictable anastomosis complication. Its prevalence for colon surgery is estimated around 2 to 5%. The onset of an AL significantly increase postoperative morbidity from 6 to 13%.

Numerous studies have tried to identify risk factors for AL after colorectal surgery. For example, male gender, patient nutritional status, smoking or American Society of Anesthesiologists score > 3 (ASA score) have been identified.

End Stage Renal Disease (ESRD) has been shown as an independent risk factor but the impact of kidney transplantation on AL is debated. Moreover, majority of the studies have worked on in-patients populations including both elective and emergent surgical procedures.

Over the last few years there has been a permanent increase in number of kidney transplantations. For example,in France from 2010 to 2014, the standardized prevalence of renal transplantation has increased from 3% each year. Patients live longer with a life-long immunosuppressive (IS) treatment but they face some colorectal complications. It has been described that solid organ transplantation such as renal transplantation is associated with a higher risk of colorectal. Also, complicated diverticular disease has been reported more frequently in renal transplanted patients. Both of these complications are explained by immunosuppression.

Thus, this population will benefit from colorectal surgery and elective surgery more often than general population.

As a consequence, the investigators found interesting to study elective left-sided colectomy on kidney transplant recipients. The aim of the study was to examine the short-term outcomes of elective left-sided colectomy in a renal transplanted population and long-term outocmes. The primary outmoe was the onset of an anastomotic leakage (time frame 90 days). The secondaries outcomes were overall morbidity defining the morbi-martality rate during that same period of time (90 days post operatively).

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Long term outcomes
    • Time Frame: 1 day
    • Long term outcomes

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Collaborator
    • Department of Visceral and Digestive Surgery, Centre hospitalier de Dunkerque
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • REGIS SOUCHE, Study Director, University Hospital, Montpellier

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