Renal CancerNCT05823545
Assessment of Complications in Patients Who Underwent LPN According to the CCI
An observational study of Renal Cancer and Surgery-Complications, run by Samsun Liv Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the strength of the classical Clavien-Dindo classification system (CDC), which is a Likert scale analysis versus the comprehensive complication index (CCI), a new quantitative evaluation system, in patients undergoing laparoscopic partial nephrectomy (LPN). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cancer, Surgery-Complications
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 3 Mar 2021
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: A retrospective analysis was carried out on 517 surgical procedures in 503 patients who underwent LPN between November 2009 and August 2020 in a tertiary university hospital. Sixty-two patients with postoperative complications were included in the study.
Who may be able to join
- patients with complete data
- patients with consent
- Patients > 18 year-old
- The surgeries performed by the surgeon EO
Who cannot join
- Missing data
- patients without consent
- patients who underwent open or retroperitoneoscopic laparoscopic partial 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: Which is Better to Assess Postoperative Complications in Patients Undergoing Laparoscopic Partial Nephrectomy?: Clavien-Dindo Classification Versus Comprehensive Complication Index.
This study aims to compare the strength of the classical Clavien-Dindo classification system (CDC), which is a Likert scale analysis versus the comprehensive complication index (CCI), a new quantitative evaluation system, in patients undergoing laparoscopic partial nephrectomy (LPN).
Read the detailed description
Prospectively collected data of sixty-two patients undergoing LPN with postoperative complications from November 2009 to August 2020 were evaluated retrospectively. Postoperative complications were classified according to the CDCs and calculated using the CCI calculator (https://www.assessurgery.com) quantitatively. Major complications were determined as ≥ grade 3 complications according to the CDC. The complexity of the renal mass was defined according to the RENAL nephrometry score. The cut-off value for CCI was analyzed by the ROC analysis technique. The significance level was taken as p<0.05.
- Conditions
- Renal Cancer, Surgery-Complications
- Keywords
- laparoscopy, partial nephrectomy, complication, CCI, urology
- Medical subject headings
- Kidney Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication
Abnormal clinical and laboratory findings that may be seen after surgery and require additional intervention, treatment, or follow-up
Measured: up to 3 months, postoperatively
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 (minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Feb 2020
- Primary completion7 Oct 2020
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal CancerStudies 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
- 62 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, Department of UrologyMehmet N Mercimek, Assoc. Prof., Principal investigator, Atasam Hospital, Departmen of Urology, Samsun, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823545
- Sponsor's protocol ID
- OMU KAEK 26.12.2019/876
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loffel LM, Gross T, Schneider MP, Burkhard FC, Thalmann GN, Bosshard P, Wuethrich PY, Furrer MA. Complication reporting with the Bern Comprehensive Complication Index CCI after open radical prostatectomy: A longitudinal long-term single-center study. Urol Oncol. 2020 Mar;38(3):79.e1-79.e8. doi: 10.1016/j.urolonc.2019.09.021. Epub 2019 Dec 31.
PubMed 31899103Slankamenac K, Nederlof N, Pessaux P, de Jonge J, Wijnhoven BP, Breitenstein S, Oberkofler CE, Graf R, Puhan MA, Clavien PA. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014 Nov;260(5):757-62; discussion 762-3. doi: 10.1097/SLA.0000000000000948.
PubMed 25379846Kim TH, Suh YS, Huh YJ, Son YG, Park JH, Yang JY, Kong SH, Ahn HS, Lee HJ, Slankamenac K, Clavien PA, Yang HK. The comprehensive complication index (CCI) is a more sensitive complication index than the conventional Clavien-Dindo classification in radical gastric cancer surgery. Gastric Cancer. 2018 Jan;21(1):171-181. doi: 10.1007/s10120-017-0728-3. Epub 2017 Jun 8.
PubMed 28597328
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which is Better to Assess Postoperative Complications in Patients Undergoing Laparoscopic Partial Nephrectomy?: Clavien-Dindo Classification Versus Comprehensive Complication Index.
- ClinicalTrials.gov ID
- NCT05823545
- Acronym / sponsor ID
- OMU KAEK 26.12.2019/876
- Conditions
- Renal Cancer, Surgery-Complications
- Keywords
- laparoscopy, partial nephrectomy, complication, CCI, urology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Samsun Liv HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 21 Apr 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.
This study aims to compare the strength of the classical Clavien-Dindo classification system (CDC), which is a Likert scale analysis versus the comprehensive complication index (CCI), a new quantitative evaluation system, in patients undergoing laparoscopic partial nephrectomy (LPN).
Detailed description
Prospectively collected data of sixty-two patients undergoing LPN with postoperative complications from November 2009 to August 2020 were evaluated retrospectively. Postoperative complications were classified according to the CDCs and calculated using the CCI calculator (https://www.assessurgery.com) quantitatively. Major complications were determined as ≥ grade 3 complications according to the CDC. The complexity of the renal mass was defined according to the RENAL nephrometry score. The cut-off value for CCI was analyzed by the ROC analysis technique. The significance level was taken as p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A retrospective analysis was carried out on 517 surgical procedures in 503 patients who underwent LPN between November 2009 and August 2020 in a tertiary university hospital. Sixty-two patients with postoperative complications were included in the study.
Key inclusion criteria (4 listed)
- patients with complete data
- patients with consent
- Patients > 18 year-old
- The surgeries performed by the surgeon EO
Key exclusion criteria (3 listed)
- Missing data
- patients without consent
- patients who underwent open or retroperitoneoscopic laparoscopic partial 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
Postoperative complication
Time frame: up to 3 months, postoperatively
Abnormal clinical and laboratory findings that may be seen after surgery and require additional intervention, treatment, or follow-up
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 (minute)
Its starts when the renal artery and vein are controlled and it ends when reperfusion of the graft kidney starts on the back table
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 25 Apr 2023.
- Background: PubMed 31899103Loffel LM, Gross T, Schneider MP, Burkhard FC, Thalmann GN, Bosshard P, Wuethrich PY, Furrer MA. Complication reporting with the Bern Comprehensive Complication Index CCI after open radical prostatectomy: A longitudinal long-term single-center study. Urol Oncol. 2020 Mar;38(3):79.e1-79.e8. doi: 10.1016/j.urolonc.2019.09.021. Epub 2019 Dec 31.
- Results publication: PubMed 25379846Slankamenac K, Nederlof N, Pessaux P, de Jonge J, Wijnhoven BP, Breitenstein S, Oberkofler CE, Graf R, Puhan MA, Clavien PA. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014 Nov;260(5):757-62; discussion 762-3. doi: 10.1097/SLA.0000000000000948.
- Results publication: PubMed 28597328Kim TH, Suh YS, Huh YJ, Son YG, Park JH, Yang JY, Kong SH, Ahn HS, Lee HJ, Slankamenac K, Clavien PA, Yang HK. The comprehensive complication index (CCI) is a more sensitive complication index than the conventional Clavien-Dindo classification in radical gastric cancer surgery. Gastric Cancer. 2018 Jan;21(1):171-181. doi: 10.1007/s10120-017-0728-3. Epub 2017 Jun 8.
- Surgical techniqueLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, Department of Urology
Mehmet N Mercimek, Assoc. Prof. principal investigator
Atasam Hospital, Departmen of Urology, Samsun, Turkey
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 Renal Cancer and Surgery-Complications, 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 4 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 25 Apr 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?
Postoperative complication (time frame: up to 3 months, postoperatively). The study lists 4 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 NCT05823545, which also lists 3 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 25 Apr 2023.