Impact of the COVID-19 Pandemic on the Surgical Activity of Bellvitge University Hospital
2021年3月2日 更新者：Marta Caballero Milan、Hospital Universitari de Bellvitge
Impact of the SARS-CoV-2 (COVID-19) Pandemic on the Morbidity and Mortality of Patients Undergoing Surgery at Bellvitge University Hospital
COVID-19 has been a challenge for hospitals; there was an obvious need to reconvert many spaces in specific areas to attend this pathology, without forgetting the attention to other pathologies and surgery.
The objective of the investigators is to evaluate the impact of this pandemic in the patients who underwent surgery in Bellvitge University Hospital, analyzing 2 periods of time: the months before the COVID-19 peak and the COVID-19 peak months.
調査の概要
状態
完了
詳細な説明
A total of 2.530 procedures have been evaluated in this retrospective observational study.
Two groups have been generated (pre-pandemic period and pandemic period), classified into scheduled and emergency surgery.
The investigators determined age, type of surgery and specialty, hospital stay, destination at discharge including mortality and severity according to Diagnostic Related to Group (DRG) scale.
The investigators have also determined the number of confirmed COVID-19 infections in patients who underwent surgery during these 2 periods and evaluated if the infection was due to a nosocomial infection (confirmation of the COVID-19 during the hospitalization period).
Comparisons were made between subgroups: scheduled surgery performed during the 2 periods and emergency surgery performed during the 2 periods.
研究の種類
観察的
入学 (実際)
2530
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Barcelona
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Hospitalet de Llobregat、Barcelona、スペイン、08907
- Marta Caballero
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
なし
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
The requirement to include patients was that they required surgery, either urgent or scheduled, during the periods described (PreCOVID and COVID).
As there is no paediatric service in the hospital, the minimum age of the sample is 18 years old but there is no maximum age for inclusion.
説明
Inclusion Criteria:
- All surgical patients operated, both elective scheduled and emergent cases
Exclusion Criteria:
- Minor-intermediate surgery that involves discharge from the hospital on the same day of the surgery from the Pre-pandemic period.
- Procedures related to medical treatment or complications of COVID-19 patients, such as chest tubes, extracorporeal oxygenation or tracheostomy.
- Those scheduled elective surgery patients in the Covid period that resulted RT-PCR positive, surgery was posponed, were not considered eligible for the analysis.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Pre-pandemic COVID-19 group (PreCOVID)
All patients who underwent surgery from 13th January until 29th February 2020, which are considered free of COVID-19 patients, therefore pre-pandemic period.
|
Administrative database was automatically collected.
That included demographic, clinical antecedents, surgical team and surgical procedure, primary and secondary diagnoses and principal and secondary surgical procedures.
A case-mix grouping system administrative automatic recorded based on the ICD-10-AM International Classification of Diseases.
According to the Diagnoses-related Groups (DRG's).
the Severity of Illness Index assigns to each patient an overall severity score (from 1 to 4) and mortality risk score (from 1 to 4)
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|
Pandemic COVID-19 group (COVID)
All patients who underwent surgery from 11th March 2020 until 15th May 2020, which were done during the first wave of the pandemic crisis.
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Administrative database was automatically collected.
That included demographic, clinical antecedents, surgical team and surgical procedure, primary and secondary diagnoses and principal and secondary surgical procedures.
A case-mix grouping system administrative automatic recorded based on the ICD-10-AM International Classification of Diseases.
According to the Diagnoses-related Groups (DRG's).
the Severity of Illness Index assigns to each patient an overall severity score (from 1 to 4) and mortality risk score (from 1 to 4)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Register the post-surgical complications
時間枠：PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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Register and Compare the Rate of Surgical Reintervention between both periods.
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PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Register the rate of surgical reintervention
時間枠：PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
|
Register and compare the Rate of reintervention between both periods.
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PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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Register the ICU admission
時間枠：PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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register and compare the ICU admission between both periods.
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PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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Register the Hospital stay
時間枠：PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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register and compare the ICU admission between both periods.
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PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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Register the Mortality
時間枠：PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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register and compare the Mortality between both periods.
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PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Maria Jose MJ Colomina, PhD、Head of the Department
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年2月13日
一次修了 (実際)
2020年5月15日
研究の完了 (実際)
2020年12月9日
試験登録日
最初に提出
2021年3月1日
QC基準を満たした最初の提出物
2021年3月2日
最初の投稿 (実際)
2021年3月3日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月3日
QC基準を満たした最後の更新が送信されました
2021年3月2日
最終確認日
2021年3月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- COVID19 surgical impact
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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