UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000034455
Receipt No. R000039274
Scientific Title VALIDATION OF POSSUM, P-POSSUM AND THE SURGICAL RISK SCALE IN SURGICAL AUDIT OF PATIENTS UNDERGOING MAJOR GENERAL SURGICAL OPERATIONS IN HARARE.
Date of disclosure of the study information 2018/10/12
Last modified on 2019/05/09 (Ver. 4)

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Basic information
Public title VALIDATION OF POSSUM, P-POSSUM AND THE SURGICAL RISK SCALE IN SURGICAL AUDIT OF PATIENTS UNDERGOING MAJOR GENERAL SURGICAL OPERATIONS IN HARARE.
Acronym VALIDATION OF POSSUM, P-POSSUM AND THE SURGICAL RISK SCALE IN AUDIT OF PATIENTS UNDERGOING MAJOR GENERAL SURGICAL OPERATIONS IN HARARE.
Scientific Title VALIDATION OF POSSUM, P-POSSUM AND THE SURGICAL RISK SCALE IN SURGICAL AUDIT OF PATIENTS UNDERGOING MAJOR GENERAL SURGICAL OPERATIONS IN HARARE.
Scientific Title:Acronym VALIDATION OF POSSUM, P-POSSUM AND THE SURGICAL RISK SCALE IN AUDIT OF PATIENTS UNDERGOING MAJOR GENERAL SURGICAL OPERATIONS IN HARARE.
Region
Africa

Condition
Condition Risk Scores
Classification by specialty
Surgery in general Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
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.
Basic objectives2 Others
Basic objectives -Others To determine which preoperative and intraoperative risk factors have the greatest impact on mortality and morbidity.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measuring actual 30 day Mortality and comparing it to the expected
Key secondary outcomes Measuring actual30 day morbidity and comparing it to the expected.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All General Surgery patients aged 18 years and above undergoing a minimum of a major surgical procedure
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.
Target sample size 166

Research contact person
Last name of lead principal investigator
1st name Allan
Middle name
Last name Ngulube
Organization University of Zimbabwe
Division name Department of Surgery
Zip code +263
Address University of Zimbabwe , College of Health Sciences, Box A178 Mazowe Street Avondale, Harare, Zimbabwe
TEL +263773364652
Email drngulube@gmail.com

Public contact
1st name of contact person
1st name Allan
Middle name
Last name Ngulube
Organization University of Zimbabwe
Division name Department of Surgery
Zip code +263
Address University of Zimbabwe , College of Health Sciences, Box A178 Mazowe Street Avondale, Harare, Zimbab
TEL +263773364652
Homepage URL
Email drngulube@gmail.com

Sponsor
Institute Allan Ngulube
University of Zimbabwe
Department of Surgery
Institute
Department

Funding Source
Organization Allan Ngulube
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Zimbabwean

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Research Council of Zimbabwe (MRCZ)
Address Cnr Josiah Tongogara / Mazowe St. Harare Zimbabwe
Tel +263784956128
Email mrcz@mrcz.org.zw

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Parirenyatwa Group Of Hospitals(Harare), Harare Central Hospital(Harare)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 12 Day

Related information
URL releasing protocol N/A
Publication of results Published

Result
URL related to results and publications https://reader.elsevier.com/reader/sd/pii/S2049080119300196?token=6589675DFCBA53286DF99F1D74B8CCA802
Number of participants that the trial has enrolled 201
Results 
891kb
Results date posted
2019 Year 05 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 03 Month 24 Day
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.
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
Adverse events 
No adverse events accrued from participarting in the study as the study was observational
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
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 01 Month 13 Day
Date of IRB
2015 Year 01 Month 13 Day
Anticipated trial start date
2015 Year 01 Month 14 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 10 Month 15 Day
Date trial data considered complete
2015 Year 10 Month 30 Day
Date analysis concluded
2016 Year 01 Month 31 Day

Other
Other related information After a 30 day follow up in outpatients, 35 out of 181 patients had died of surgery related problems.

Management information
Registered date
2018 Year 10 Month 12 Day
Last modified on
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039274