Severity Grading of Unexpected Events in Pediatric Surgery

NCT ID: NCT04827641

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

670 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Complication of Surgical Procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Severity Grading assessment in children with perioperative unexpected events

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.

Intervention Type OTHER

Other Intervention Names

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According to Clavien-Dindo Classification According to T92 Classification According to contracted Accordion Classification According to extended Accordion Classification According to MSKCC Classification According to Comprehensive Complication Index (CCI®)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* If no informed consent was obtained from the legal guardian´s at admission
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Omid Madadi-Sanjani, Dr.

Consultant, Center of Pediatric Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hannover Medical School

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Omid Madadi-Sanjani, Dr

Role: CONTACT

+49-511-5329053

Facility Contacts

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Omid Madadi-Sanjani, Dr

Role: primary

+49-511-5329053

References

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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.

Reference Type BACKGROUND
PMID: 26628204 (View on PubMed)

Staiger 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.

Reference Type BACKGROUND
PMID: 30272585 (View on PubMed)

Staiger 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.

Reference Type BACKGROUND
PMID: 32925252 (View on PubMed)

Dindo 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.

Reference Type BACKGROUND
PMID: 15273542 (View on PubMed)

Strasberg 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.

Reference Type BACKGROUND
PMID: 19638919 (View on PubMed)

Zoeller 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.

Reference Type RESULT
PMID: 33353740 (View on PubMed)

Other Identifiers

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2739-2015

Identifier Type: -

Identifier Source: org_study_id

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