Complication of Surgical ProcedureNCT04827641
Severity Grading of Unexpected Events in Pediatric Surgery
An observational study of Complication of Surgical Procedure, run by Hannover Medical School at 1 site in Germany.
Trial summary
Data on all patients who experienced unexpected events at the Department of Pediatric Surgery Hannover Medical School from 1st January 2017 to 30th November 2020 were documented prospectively. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Complication of Surgical Procedure
- What is being tested?
- Severity Grading assessment in children with perioperative unexpected events
- How many people
- 670 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2017to 1 Jul 2023
- 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 0 to 18 years
- All sexes
- Child, Adult
Study population: Data on all patients (preterm infants to 18 years of age) who experienced unexpected events at the Department of Pediatric Surgery Hannover Medical School from 1st January 2017 to 30th November 2020 were documented prospectively.
Who may be able to join
- All patients with unexpected events during the in-hospital stay, in outpatient clinics and in the pediatric emergency department
- Informed consent was obtained from the legal guardian´s at admission
Who cannot join
- If no informed consent was obtained from the legal guardian´s at admission
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, Lower Saxony, 30625
Omid Madadi-Sanjani, Dr, +49-511-5329053, madadi-sanjani.omid@mh-hannover.de
About this study
Official title: Severity Grading of Unexpected Events in Pediatric Surgery - Evaluation of Five Classification Systems and the Comprehensive Complication Index (CCI®)
Data on all patients who experienced unexpected events at the Department of Pediatric Surgery Hannover Medical School from 1st January 2017 to 30th November 2020 were documented prospectively. The department represents the only tertiary academic institution of the german province of Lower-Saxony (8 million inhabitants). The clinical spectrum of the department includes surgery of the neonate, gastrointestinal, hepatobiliary, thoracic and oncological surgery and pediatric urology.
- Conditions
- Complication of Surgical Procedure
- Being tested
- Severity Grading assessment in children with perioperative unexpected events
- Keywords
- complications, unexpected events, severity grading systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severity Grading assessment in children with perioperative unexpected eventsOther
Also called According to Clavien-Dindo Classification, According to T92 Classification, According to contracted Accordion Classification, According to extended Accordion Classification
Systematic documentation of all unexpected events was carried out by designated team members during daily routine team conferences. Briefly, on-call team members and all other staff reported on any unexpected event that had occurred within the previous 24 hours, after weekends during the past 72 hours. Events included those that had occurred in inpatients, outpatients and in the pediatric emergency department. Data concerning each event included patient demographics, diagnoses, treatments/operations and types of events.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
All adverse events were prospectively documented
Measured: Through study completion, an average of 3 years
Secondary outcomes (3)
Categorization of adverse events
Events associated with surgical/non-surgical interventions and events not associated with interventions such as organizational problems, management problems or underlying disease were differentiated.
Measured: Through study completion, an average of 3 years
Classification of adverse events
According to the Clavien-Dindo-, T92-, contracted Accordion-, Extended Accordion- and MSKCC-Classification
Measured: Through study completion, an average of 3 years
Calculation of the Comprehensive Complication Index (CCI®)
Using an online tool based on the protocol by Staiger et al.(http://www.cci.assessurgery.com).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Complication of Surgical ProcedureStudies 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
- Prospective
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omid Madadi-Sanjani, Dr., Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827641
- Sponsor's protocol ID
- 2739-2015
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sethi MV, Zimmer J, Ure B, Lacher M. Prospective assessment of complications on a daily basis is essential to determine morbidity and mortality in routine pediatric surgery. J Pediatr Surg. 2016 Apr;51(4):630-3. doi: 10.1016/j.jpedsurg.2015.10.052. Epub 2015 Oct 27.
PubMed 26628204Staiger RD, Cimino M, Javed A, Biondo S, Fondevila C, Perinel J, Aragao AC, Torzilli G, Wolfgang C, Adham M, Pinto-Marques H, Dutkowski P, Puhan MA, Clavien PA. The Comprehensive Complication Index (CCI(R)) is a Novel Cost Assessment Tool for Surgical Procedures. Ann Surg. 2018 Nov;268(5):784-791. doi: 10.1097/SLA.0000000000002902.
PubMed 30272585Staiger RD, Gerns E, Castrejon Subira M, Domenghino A, Puhan MA, Clavien PA. Can Early Postoperative Complications Predict High Morbidity and Decrease Failure to Rescue Following Major Abdominal Surgery? Ann Surg. 2020 Nov;272(5):834-839. doi: 10.1097/SLA.0000000000004254.
PubMed 32925252Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Strasberg SM, Linehan DC, Hawkins WG. The accordion severity grading system of surgical complications. Ann Surg. 2009 Aug;250(2):177-86. doi: 10.1097/SLA.0b013e3181afde41.
PubMed 19638919Zoeller C, Kuebler JF, Ure BM, Brendel J. Incidence of complications, organizational problems, and errors: Unexpected events in 1605 patients. J Pediatr Surg. 2021 Oct;56(10):1723-1727. doi: 10.1016/j.jpedsurg.2020.12.004. Epub 2020 Dec 13.
PubMed 33353740
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severity Grading of Unexpected Events in Pediatric Surgery - Evaluation of Five Classification Systems and the Comprehensive Complication Index (CCI®)
- ClinicalTrials.gov ID
- NCT04827641
- Acronym / sponsor ID
- 2739-2015
- Conditions
- Complication of Surgical Procedure
- Keywords
- complications, unexpected events, severity grading systems
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 1 Apr 2021 (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.
Data on all patients who experienced unexpected events at the Department of Pediatric Surgery Hannover Medical School from 1st January 2017 to 30th November 2020 were documented prospectively. The department represents the only tertiary academic institution of the german province of Lower-Saxony (8 million inhabitants). The clinical spectrum of the department includes surgery of the neonate, gastrointestinal, hepatobiliary, thoracic and oncological surgery and pediatric urology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Data on all patients (preterm infants to 18 years of age) who experienced unexpected events at the Department of Pediatric Surgery Hannover Medical School from 1st January 2017 to 30th November 2020 were documented prospectively.
Key inclusion criteria (2 listed)
- All patients with unexpected events during the in-hospital stay, in outpatient clinics and in the pediatric emergency department
- Informed consent was obtained from the legal guardian´s at admission
Key exclusion criteria (1 listed)
- If no informed consent was obtained from the legal guardian´s at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Severity Grading assessment in children with perioperative unexpected eventsAlso: According to Clavien-Dindo Classification, According to T92 Classification, According to contracted Accordion Classification, According to extended Accordion ClassificationSystematic documentation of all unexpected events was carried out by designated team members during daily routine team conferences. Briefly, on-call team members and all other staff reported on any unexpected event that had occurred within the previous 24 hours, after weekends during the past 72 hours. Events included those that had occurred in inpatients, outpatients and in the pediatric emergency department. Data concerning each event included patient demographics, diagnoses, treatments/operations and types of events. | Other | – |
Primary outcome
Incidence of adverse events
Time frame: Through study completion, an average of 3 years
All adverse events were prospectively documented
3 secondary outcomes
Categorization of adverse events
Time frame: Through study completion, an average of 3 years
Classification of adverse events
Time frame: Through study completion, an average of 3 years
Calculation of the Comprehensive Complication Index (CCI®)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Background: PubMed 26628204Sethi MV, Zimmer J, Ure B, Lacher M. Prospective assessment of complications on a daily basis is essential to determine morbidity and mortality in routine pediatric surgery. J Pediatr Surg. 2016 Apr;51(4):630-3. doi: 10.1016/j.jpedsurg.2015.10.052. Epub 2015 Oct 27.
- Background: PubMed 30272585Staiger RD, Cimino M, Javed A, Biondo S, Fondevila C, Perinel J, Aragao AC, Torzilli G, Wolfgang C, Adham M, Pinto-Marques H, Dutkowski P, Puhan MA, Clavien PA. The Comprehensive Complication Index (CCI(R)) is a Novel Cost Assessment Tool for Surgical Procedures. Ann Surg. 2018 Nov;268(5):784-791. doi: 10.1097/SLA.0000000000002902.
- Background: PubMed 32925252Staiger RD, Gerns E, Castrejon Subira M, Domenghino A, Puhan MA, Clavien PA. Can Early Postoperative Complications Predict High Morbidity and Decrease Failure to Rescue Following Major Abdominal Surgery? Ann Surg. 2020 Nov;272(5):834-839. doi: 10.1097/SLA.0000000000004254.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 19638919Strasberg SM, Linehan DC, Hawkins WG. The accordion severity grading system of surgical complications. Ann Surg. 2009 Aug;250(2):177-86. doi: 10.1097/SLA.0b013e3181afde41.
- Results publication: PubMed 33353740Zoeller C, Kuebler JF, Ure BM, Brendel J. Incidence of complications, organizational problems, and errors: Unexpected events in 1605 patients. J Pediatr Surg. 2021 Oct;56(10):1723-1727. doi: 10.1016/j.jpedsurg.2020.12.004. Epub 2020 Dec 13.
- 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.
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 Complication of Surgical Procedure, run by Hannover Medical School at 1 site in Germany.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Apr 2021. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omid Madadi-Sanjani, Dr (+49-511-5329053, madadi-sanjani.omid@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Through study completion, an average of 3 years). 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 NCT04827641, which also lists 6 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 1 Apr 2021.