ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000525381

Ethics application status

Approved

Date submitted

28/01/2017

Date registered

10/04/2017

Date last updated

10/04/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Surgical Management of Colonic Basidiobolomycosis among adolescent and adult patients; Indications and Outcomes.

Scientific title

Surgical Management of Colonic Basidiobolomycosis among adolescent and adult patients; Indications and Outcomes.

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

basidiobolomycosis of the colon

Condition category

Condition code

Surgery

Other surgery

Infection

Other infectious diseases

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Months

Description of intervention(s) / exposure

patients with basidiobolomycosis of the colon were subjected to colectomies followed by receiving antifungal treatment for 1-2 years as the standard care of their treatment. Patients were followed up regarding recurrence of symptoms or development of recurrence in any other organ for one year after colectomies. Data were retrieved from patients files.

Intervention code [1]

Not applicable

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Survival by reviewing the file of the patient or by communicating with him for at least one year after the operation

Timepoint [1]

one year post colectomy

Secondary outcome [1]

Early postoperative complications (Leakage, wound infection, and abdominal dehiscence) by reviewing the file of the patient searching for early post operative complications (Leakage, wound infection, and abdominal dehiscence) and documenting when it was happened and how it was treated.

Timepoint [1]

one month post colectomy

Secondary outcome [2]

indications for surgery by reviewing the files of the patients for the bases up on which the decision to operate the patient was taken.

Timepoint [2]

Just before colectomy

Secondary outcome [3]

Rates of presenting symptoms of the patients by reviewing the files of the patients for different symptoms that patients were presenting before admission.

Timepoint [3]

period before admission to hospital

Secondary outcome [4]

Rates of recurrence by reviewing the files of the patients for recurrence of the disease and location of recurrence.

Timepoint [4]

one year postoperative

Eligibility

Key inclusion criteria

all patients who were diagnosed as colonic Basidiobolomycosis and required surgical intervention during the last 10 years (2006 – 2016) in Aseer Central Hospital. Colonic affection was defined as microscopic or macroscopic involvement of the colon or the rectum preoperatively by imaging or colonoscopy or intra-operatively by observation.

Minimum age

10 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients less than 10 years are treated by pediatric department.
Patients with colonic basidiobolomycosis who were treated conservatively were excluded from the study

Study design

Purpose

Duration

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

All data will be uploaded to excel sheet and %, mean and standard deviation will be calculated.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

15/04/2013

Date of last participant enrolment

Anticipated

Actual

21/01/2016

Date of last data collection

Anticipated

Actual

21/01/2016

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Saudi Arabia

State/province [1]

Aseer

Funding & Sponsors

Funding source category [1]

University

Name [1]

King Khalid University

Address [1]

Greiger
Zip: 61421
P.O.: 641
Abha
Saudi Arabia

Country [1]

Saudi Arabia

Primary sponsor type

University

Name

King Khalid University

Address

Greiger
Zip: 61421
P.O.: 641
Abha
Saudi Arabia

Country

Saudi Arabia

Secondary sponsor category [1]

Hospital

Name [1]

Aseer Central Hospital

Address [1]

King Abdullah Road PO Box 34 Zip: 62523 Abha Saudi Arabia

Country [1]

Saudi Arabia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Committee of King Khalid University

Ethics committee address [1]

Saudi Arabia Abha Greiger King Khalid University, Building C Ethical Committee PO 641, Zip 61421

Ethics committee country [1]

Saudi Arabia

Date submitted for ethics approval [1]

15/01/2013

Approval date [1]

12/02/2013

Ethics approval number [1]

REC # 2013-02-15

Summary

Brief summary

Basidiobolomycosis is a rare fungal infection caused by Basidiobolus ranarum (B ranarum). The synonym “Basidiobolomycosis” is given to diseases caused by Basidiobolaceae which is a family coming under entomophthorales which is a subdivision of Zygomycetes. B. ranarum was first described in 1886 and was isolated from frogs. It has  been found in decaying vegetation, foodstuffs, fruits, and soil. It is also excreted from the gastrointestinal tracts of reptiles, amphibians, fish, and insectivorous bats. 

The organism B ranarum may be found all over the world but Basidiobolomycosis is most commonly reported from tropical and subtropical areas of the world. It typically causes a subcutaneous disease of arms, trunks and buttocks. The mode of transmission is assumed to be minor skin trauma and insect bites. Extracutaneous Basidiobolomycosis is rare, however,  it has been reported in lungs, retroperitoneum  and gastrointestinal system. Iatrogenic causes of infections, like needle transmission, has also been suggested by some authors. The disease may be transmitted by inhalation, by the soil, water and vegetation that is contaminated with animal feaces. 
Gastrointestinal basidiobolomycosis (GIB) is considered to be a rare type of mycosis that is characteristically being reported in immunocompetent rather than immunocompromised patients. The first presumed case of GIB was reported in a 6 year old Nigerian boy in 1964  while the first culture proven case was diagnosed in 1986 in USA. During the last 30 years the reported cases were diagnosed mainly from arid desert region of USA and from Middle Eastern countries especially Saudi Arabia. Clinically, gastrointestinal basidiobolomycosis may mimic malignancy, inflammatory bowel disease or chronic infections like tuberculosis. Due the rarity of the disease and its wide spectrum of presentations, high index of suspicion may be required for accurate diagnosis. Serological tests and histopathological findings can help in diagnosing the condition, nevertheless, the most definitive diagnostic tool is culture. Among all GIB reported cases, colon is the most common organ involved and may reach up to 82% of the affected organs in some reports. Moreover, surgical intervention is required in most of these cases. 

In this study we are reviewing the clinical presentations, indications and surgical outcomes of all patients who were diagnosed and treated from colonic basidiobolomycosis in the last 10 years in Aseer Central Hospital, A tertiary referral hospital in the southern region of Saudi Arabia.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/372246(v16-02-2017-19-34-19)-Ethical approval.docx (Ethics approval)

Contacts

Principal investigator

Name

A/Prof Walid Abd El Maksoud MD, PhD, MRCS

Address

King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641

Country

Saudi Arabia

Phone

+966543128555

Fax

[email protected]

Contact person for public queries

Name

Walid Abd El Maksoud MD, PhD, MRCS

Address

King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641

Country

Saudi Arabia

Phone

+966543128555

Fax

[email protected]

Contact person for scientific queries

Name

Walid Abd El Maksoud MD, PhD, MRCS

Address

King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641

Country

Saudi Arabia

Phone

+966543128555

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Surgical management of colonic basidiobolomycosis among adolescent and adult patients: presentation and outcome.	2018	https://dx.doi.org/10.1111/codi.13939

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically