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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000034455
受付番号 R000039274
科学的試験名
一般公開日(本登録希望日) 2018/10/12
最終更新日 2019/05/09

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
VALIDATION OF POSSUM, P-POSSUM AND THE SURGICAL RISK SCALE IN SURGICAL AUDIT OF PATIENTS UNDERGOING MAJOR GENERAL SURGICAL OPERATIONS IN HARARE.
一般向け試験名略称/Acronym
VALIDATION OF POSSUM, P-POSSUM AND THE SURGICAL RISK SCALE IN AUDIT OF PATIENTS UNDERGOING MAJOR GENERAL SURGICAL OPERATIONS IN HARARE.
科学的試験名/Scientific Title
VALIDATION OF POSSUM, P-POSSUM AND THE SURGICAL RISK SCALE IN SURGICAL AUDIT OF PATIENTS UNDERGOING MAJOR GENERAL SURGICAL OPERATIONS IN HARARE.
科学的試験名略称/Scientific Title:Acronym
VALIDATION OF POSSUM, P-POSSUM AND THE SURGICAL RISK SCALE IN AUDIT OF PATIENTS UNDERGOING MAJOR GENERAL SURGICAL OPERATIONS IN HARARE.
試験実施地域/Region
アフリカ/Africa

対象疾患/Condition
対象疾患名/Condition
Risk Scores
疾患区分1/Classification by specialty
外科学一般/Surgery in general 手術医学/Operative medicine
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
To determine if there is any significant difference between calculated versus observed operative mortality and morbidity scores in Harare using POSSUM, P-POSSUM and SRS.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
To determine which preoperative and intraoperative risk factors have the greatest impact on mortality and morbidity.
試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Measuring actual 30 day Mortality and comparing it to the expected
副次アウトカム評価項目/Key secondary outcomes
Measuring actual30 day morbidity and comparing it to the expected.

基本事項/Base
試験の種類/Study type 観察/Observational

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
All General Surgery patients aged 18 years and above undergoing a minimum of a major surgical procedure
除外基準/Key exclusion criteria
Patients below the age of 18 years.
Any patient managed conservatively.
Any patient operated by a registrar with less than 2 years of surgical training.
Day cases and any procedure categorised as minor.
More than 1 missing result.
Any patient requiring admission into a critical care unit post operatively but failed because of shortage of beds.
目標参加者数/Target sample size 166

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Allan
ミドルネーム
Ngulube
所属組織/Organization
University of Zimbabwe
所属部署/Division name
Department of Surgery
郵便番号/Zip code +263
住所/Address
University of Zimbabwe , College of Health Sciences, Box A178 Mazowe Street Avondale, Harare, Zimbabwe
電話/TEL +263773364652
Email/Email drngulube@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Allan
ミドルネーム
Ngulube
組織名/Organization
University of Zimbabwe
部署名/Division name
Department of Surgery
郵便番号/Zip code +263
住所/Address
University of Zimbabwe , College of Health Sciences, Box A178 Mazowe Street Avondale, Harare, Zimbab
電話/TEL +263773364652
試験のホームページURL/Homepage URL
Email/Email drngulube@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Allan Ngulube
University of Zimbabwe
Department of Surgery
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Allan Ngulube
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization
Zimbabwean

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Medical Research Council of Zimbabwe (MRCZ)
住所/Address
Cnr Josiah Tongogara / Mazowe St. Harare Zimbabwe
電話/Tel +263784956128
Email/Email mrcz@mrcz.org.zw

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions Parirenyatwa Group Of Hospitals(Harare), Harare Central Hospital(Harare)

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2018 10 12

関連情報/Related information
プロトコル掲載URL/URL releasing protocol N/A
試験結果の公開状況/Publication of results 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications https://reader.elsevier.com/reader/sd/pii/S2049080119300196?token=6589675DFCBA53286DF99F1D74B8CCA802
組み入れ参加者数/Number of participants that the trial has enrolled 201
主な結果/Results
891kb
主な結果入力日/Results date posted
2019 05 09
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
2019 03 24
参加者背景/Baseline Characteristics
A prospective observational cohort study was done with a minimumsample size of 166 using the Dobson formula. The study was conductedat Parirenyatwa Group of Hospitals (PGH) and Harare Central Hospital(HCH) over a 9 month period from January to September of 2015. Thestudy included all consecutively admitted patients aged 18 years andabove undergoing at least a major general surgical procedure as definedby the British United Provident Association , with timing ranging from elective to emergency. Patients were excluded if below the age of18 years, if managed conservatively, if it was a day case or any pro-cedure categorized as minor and any case falling outside the scope ofgeneral surgery. Those also excluded were patients with more than 1 missing result or those requiring admission into a critical care unit postoperatively but failed because of shortage of beds and those operated by surgical trainees with less than 2 years experience.
参加者の流れ/Participant flow
Using a predesigned data collection tool, results from investigations done immediately preoperatively plus operative findings and post op-erative histology were collected. Complications, as defined by Copeland et al, were recorded as observed by the attending surgeons with confirmatory tests where necessary. Patients were followed up for amonth in Outpatients Department (OPD) and a follow up phone call was done for those not available for review. The actual calculation for the risk scores was done with a computer program utilising the stated formulae . The calculated risk scores for individual patients were stratified according to magnitude then compared with the actual observed number of mortalities or morbidities in each category with Chi-Square as a test for significance at 95% significance. Regression analysis of risk factors contributing to mortality and morbidity was also done with appropriate calculations for significance testing using statistical software
有害事象/Adverse events
No adverse events accrued from participarting in the study as the study was observational
評価項目/Outcome measures
Mortality and Morbidity related to the procedures the patients were going through were the outcome measures compared to the calculated mortality and morbidity
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2015 01 13
倫理委員会による承認日/Date of IRB
2015 01 13
登録・組入れ開始(予定)日/Anticipated trial start date
2015 01 14
フォロー終了(予定)日/Last follow-up date
2015 09 30
入力終了(予定)日/Date of closure to data entry
2015 10 15
データ固定(予定)日/Date trial data considered complete
2015 10 30
解析終了(予定)日/Date analysis concluded
2016 01 31

その他/Other
その他関連情報/Other related information
After a 30 day follow up in outpatients, 35 out of 181 patients had died of surgery related problems.

管理情報/Management information
登録日時/Registered date
2018 10 12
最終更新日/Last modified on
2019 05 09


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000039274
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039274

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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