The Learning Curve for Retroperitoneoscopic Donor Nephrectomy

NCT05790746 | Completed DMC

• 1 other identifier: OMU KAEK 11.07.2019/533
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transplant;Failure,Kidney

Keywords

retroperitoneoscopy; donor nephrectomy; Learning curve; CUSUM analysis

Outcome Measures

Primary Outcomes (3)

• Opertaion time

  From first trocar incision to closure of all incisions

  during the surgery (minute)

• Estimeted blood loss

  perioperative estimated blood loss

  during the surgery (mL)

• warm ischemia time

  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 Outcomes (1)

• Learning curve

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Samsun Liv Hospital: lead

Study Sites (1)

Ondokuz Mayıs University, Department of Urology

Samsun, 55020, Turkey (Türkiye)

Location

Related Publications (2)

• Pal BC, Modi PR, Rizvi SJ, Chauhan R, Kumar S, Nagarajan R, Kaushal D, Kute VB, Trivedi HL. The Learning Curve of Pure Retroperitoneoscopic Donor Nephrectomy. Int J Organ Transplant Med. 2017;8(4):180-185. Epub 2017 Nov 1.

  PMID: 29321833 RESULT

• Kudsi OY, Gokcal F, Bou-Ayash N, Crawford AS. Learning curve of robotic transversus abdominis release in ventral hernia repair: a cumulative sum (CUSUM) analysis. Surg Endosc. 2022 May;36(5):3480-3488. doi: 10.1007/s00464-021-08669-7. Epub 2021 Sep 7.

  PMID: 34494150 RESULT

Related Links

• Surgical technique

Study Officials

• Ender Ozden, Prof.

  Ondokuz Mayıs University, Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, FEBU

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 30, 2023
• Study Start: August 1, 2019
• Primary Completion: November 3, 2019
• Study Completion: September 9, 2020
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

TU (1)