Transplant;Failure,KidneyNCT05790746
The Learning Curve for Retroperitoneoscopic Donor Nephrectomy
An observational study of Transplant;Failure,Kidney, run by Samsun Liv Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Transplant;Failure,Kidney
- How many people
- 172 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 9 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Missing data
- patients without consent
- patients who underwent open of transperitoneal laparoscopic donor nephrectomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University, Department of Urology
Samsun, 55020
About this study
Official title: 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
Read the 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.
- Conditions
- Transplant;Failure,Kidney
- Keywords
- retroperitoneoscopy, donor nephrectomy, Learning curve, CUSUM analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Opertaion time
From first trocar incision to closure of all incisions
Measured: during the surgery (minute)
Estimeted blood loss
perioperative estimated blood loss
Measured: 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
Measured: during the surgery (second)
Secondary outcomes (1)
Learning curve
Number of cases required to achieve reduction in operative time, warm ischemia time, and estimated blood loss.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Aug 2019
- Primary completion3 Nov 2019
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transplant;Failure,KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Liv Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet N. Mercimek, MD, FEBU, Samsun Liv Hospital
- Investigators
- Ender Ozden, Prof., Study chair, Ondokuz Mayıs University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790746
- Sponsor's protocol ID
- OMU KAEK 11.07.2019/533
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29321833Kudsi 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.
PubMed 34494150
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Learning Curve for Pure Retroperitoneoscopic Donor Nephrectomy by Using Cumulative Sum Analysis
- ClinicalTrials.gov ID
- NCT05790746
- Acronym / sponsor ID
- OMU KAEK 11.07.2019/533
- Conditions
- Transplant;Failure,Kidney
- Keywords
- retroperitoneoscopy, donor nephrectomy, Learning curve, CUSUM analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Samsun Liv HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 3 Nov 2019 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Missing data
- patients without consent
- patients who underwent open of transperitoneal laparoscopic donor nephrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opertaion time
Time frame: during the surgery (minute)
From first trocar incision to closure of all incisions
Estimeted blood loss
Time frame: during the surgery (mL)
perioperative estimated blood loss
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
1 secondary outcome
Learning curve
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Results publication: PubMed 29321833Pal 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.
- Results publication: PubMed 34494150Kudsi 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.
- Surgical techniqueLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ender Ozden, Prof. study chair
Ondokuz Mayıs University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant;Failure,Kidney, run by Samsun Liv Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opertaion time (time frame: during the surgery (minute)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05790746, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.