SURGICAL EXPERIENCE ON RENAL TRANSPLANT COMPLICATIONS | NCT05200949

Studies
SURGICAL EXPERIENCE ON RENAL TRANSPLANT COMPLICATIONS

NCT05200949

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Feb 7, 2022Actual

Enrollment

303Actual

Phase

Not provided

Conditions

Kidney Transplant Failure

Interventions

Kidney transplant

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2013Actual

Primary Completion Date

Dec 31, 2015Actual

Completion Date

Dec 31, 2015Actual

First Submitted Date

Jan 7, 2022

First Submission Date that Met QC Criteria

Jan 7, 2022

First Posted Date

Jan 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2022

Last Update Posted Date

Feb 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Kidney transplantation (KT) failure could be due to surgery dependent factors and particularly surgeon's experience.

Objective: To assess the impact of the surgeon's experience on the post-operative outcomes to know if it safe for young surgeons to perform it.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

303Actual

Name	Type	Description	Arm Group Labels	Other Names
Kidney transplant	Procedure	Transplant surgery of Kidney

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complication post surgery	complication occurrence using the Clavien Dindo score	1 month after transplant

Secondary Outcomes

Measure	Description	Time Frame
function of the transplanted kidney	concentration of the creatininemia	within 1 year after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent Kidney Transplant in CHU of Nice
Patient for whom a minimum of 12 months follow up is possible.

Exclusion Criteria:

- Patients who underwent a dual Kidney Transplant or a multi-organ transplant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

all patient who was treated with a kidney transplantation in CHU of Nice

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de NICE		Nice		06003	France

IPD Sharing Statement Module

Plan to Share IPD

Description

No sharing data plan was established.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016030	Kidney Transplantation

Ancestor Terms

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D016377	Organ Transplantation
D014180	Transplantation

Browse Leaves

Not provided

Browse Branches

Not provided