The Learning Curve for Retroperitoneoscopic Donor Nephrectomy

March 16, 2023 updated by: Mehmet N. Mercimek, MD, FEBU, Samsun Liv Hospital

The Learning Curve for Pure Retroperitoneoscopic Donor Nephrectomy by Using Cumulative Sum Analysis

Purpose: The aim of the study is to identify a precise learning curve for pure retroperitoneoscopic donor nephrectomy (RDN).

Methods: Data from 172 consecutive kidney donors who underwent pure RDN between January 2010 and July 2019 were prospectively collected and evaluated. CUSUM (cumulative sum) analysis was used for testing the operation time. Changepoints were determined by using the R program and BinSeg method. The cohort was divided into three groups. Group 1 refers to competence including the first 10 cases, group 2: 11- 48 cases as proficiency, and group 3: the subsequent 124 cases as expert level. Continuous variables were evaluated using one-way ANOVA, and categorical data were evaluated using the Chi-square test

Study Overview

Status

Completed

Conditions

Transplant;Failure,Kidney

Detailed Description

The prospectively collected data of 172 consecutive kidney donors undergoing pure RDN for transplantation at Ondokuz Mayıs University from January 2010 to July 2019 were evaluated retrospectively. Tc-99m mercaptoacetyltriglycine (MAG3) renal scintigraphy was performed to evaluate for split renal function. Three-dimensional computed tomography was performed to evaluate kidney anatomy and vasculature. The final decision for the laterality of surgery was based on the conviction that the better kidney remains with the donor. If both kidneys have equal functional characteristics, the left kidney or the kidney with simpler vascular anatomy was procured based on the transplantation medical review board's decision. The demographic data including age, gender, body mass index (BMI), preoperative renal function, number of renal arteries and veins were recorded. Perioperative variables such as operation time (OT), warm ischemia time (WIT), estimated blood loss (EBL), perioperative and postoperative complications were also recorded. Furthermore, the outcomes of renal recipients including graft function, complications and follow-up were recorded as well. In our previously published article provides a thorough description of the surgical procedure and details for the right and left sides of pure RDN. All RNDs were performed by a single surgeon with experience in retroperitoneoscopic laparoscopic surgery and kidney transplantation.

Learning curve analysis The CUSUM analysis and BinSeg (Binary Segmentation) method Although the CUSUM analysis was first built to evaluate industrial sector performance, it has been adopted in medicine to interpret many surgical techniques learning curve. In a timeline, it calculates the sum of the existing differences between individual operation times and the mean of all operation times. Its main use of in medicine is that calculates the sum of the existing differences between individual operation times and the mean of all operation times in a timeline. The next step is to identify significant change points to determine the development. The "changepoint" package was used in the R program to determine the change points. The changepoints were determined according to the mean variation. BinSeg methods were used to identify two exchange points. Penalty methods were not used to determine surgical time change points. The "Normal" method was used as the test statistic for the surgical time. According to the learning curve analysis methods that are mentioned above, the whole cohort was divided into three groups. Inspired by the Dreyfus model of skill acquisition in the naming of the groups. Thus, group 1 represents competence, group 2 is proficiency level, and group 3 is the expert level.

Study Type

Observational

Enrollment (Actual)

172

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

Turkey
- - Samsun, Turkey, 55020
    - Ondokuz Mayıs University, Department of Urology

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

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The prospectively collected data of 172 consecutive kidney donors undergoing pure retroperitoneoscopic donor nephrectomy for renal transplantation at Ondokuz Mayıs University, Faculty of Medicine, Department of Urology from January 2010 to July 2019 were evaluated retrospectively.

Description

Inclusion Criteria:

patients with complete data
patients with consent
Patients > 18 year-old
The surgeries performed by the surgeon EO
Patients who underwent retroperitoneoscopic donor nephrectomy at Ondokuz Mayıs University, Department of Urology

Exclusion Criteria:

Missing data
patients without consent
patients who underwent open of transperitoneal laparoscopic donor nephrectomy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opertaion time Time Frame: during the surgery (minute)	From first trocar incision to closure of all incisions	during the surgery (minute)
Estimeted blood loss Time Frame: during the surgery (mL)	perioperative estimated blood loss	during the surgery (mL)
warm ischemia time Time Frame: during the surgery (second)	Its starts when the renal artery and vein are controlled and it ends when reperfusion of the graft kidney starts on the back table	during the surgery (second)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Learning curve Time Frame: through study completion, an average of 1 year	Number of cases required to achieve reduction in operative time, warm ischemia time, and estimated blood loss.	through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Samsun Liv Hospital

Investigators

Study Chair: Ender Ozden, Prof., Ondokuz Mayıs University, Faculty of Medicine

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

Helpful Links

Surgical technique

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)

August 1, 2019

Primary Completion (Actual)

November 3, 2019

Study Completion (Actual)

September 9, 2020

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)