Left Elective Colectomy in Renal Transplanted Patients

NCT ID: NCT04495023

Last Updated: 2020-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-04-01

Brief Summary

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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

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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.

Conditions

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Left Elective Colectomy Renal Transplanted Patients

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Left elective colectomy

Intervention Type PROCEDURE

Open or laparoscopic left elective colectomy with colo-rectal anastomosis

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.

Left elective colectomy

Intervention Type PROCEDURE

Open or laparoscopic left elective colectomy with colo-rectal anastomosis

Interventions

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Left elective colectomy

Open or laparoscopic left elective colectomy with colo-rectal anastomosis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Visceral and Digestive Surgery, Centre hospitalier de Dunkerque

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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REGIS SOUCHE

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33511479 (View on PubMed)

Other Identifiers

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RECHMPL20_0356

Identifier Type: -

Identifier Source: org_study_id

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