UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034455
Receipt number 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 20:04:21

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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

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

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 or person

Institute

Allan Ngulube
University of Zimbabwe
Department of Surgery

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039274


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name