Trial Review

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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] 291024 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
basidiobolomycosis of the colon 301809 0
Condition category
Condition code
Surgery 301492 301492 0 0
Other surgery
Infection 301493 301493 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
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] 296996 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300884 0
Survival by reviewing the file of the patient or by communicating with him for at least one year after the operation
Timepoint [1] 300884 0
one year post colectomy
Secondary outcome [1] 331112 0
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] 331112 0
one month post colectomy
Secondary outcome [2] 331113 0
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] 331113 0
Just before colectomy
Secondary outcome [3] 333142 0
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] 333142 0
period before admission to hospital
Secondary outcome [4] 333143 0
Rates of recurrence by reviewing the files of the patients for recurrence of the disease and location of recurrence.
Timepoint [4] 333143 0
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?
No
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
20
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 8609 0
Saudi Arabia
State/province [1] 8609 0
Aseer

Funding & Sponsors
Funding source category [1] 295451 0
University
Name [1] 295451 0
King Khalid University
Country [1] 295451 0
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] 294273 0
Hospital
Name [1] 294273 0
Aseer Central Hospital
Address [1] 294273 0
King Abdullah Road PO Box 34 Zip: 62523 Abha Saudi Arabia
Country [1] 294273 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296783 0
Ethical Committee of King Khalid University
Ethics committee address [1] 296783 0
Saudi Arabia Abha Greiger King Khalid University, Building C Ethical Committee PO 641, Zip 61421
Ethics committee country [1] 296783 0
Saudi Arabia
Date submitted for ethics approval [1] 296783 0
15/01/2013
Approval date [1] 296783 0
12/02/2013
Ethics approval number [1] 296783 0
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] 1460 1460 0 0
/AnzctrAttachments/372246(v16-02-2017-19-34-19)-Ethical approval.docx (Ethics approval)

Contacts
Principal investigator
Name 72042 0
A/Prof Walid Abd El Maksoud MD, PhD, MRCS
Address 72042 0
King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641
Country 72042 0
Saudi Arabia
Phone 72042 0
+966543128555
Fax 72042 0
Email 72042 0
[email protected]
Contact person for public queries
Name 72043 0
A/Prof Walid Abd El Maksoud MD, PhD, MRCS
Address 72043 0
King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641
Country 72043 0
Saudi Arabia
Phone 72043 0
+966543128555
Fax 72043 0
Email 72043 0
[email protected]
Contact person for scientific queries
Name 72044 0
A/Prof Walid Abd El Maksoud MD, PhD, MRCS
Address 72044 0
King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641
Country 72044 0
Saudi Arabia
Phone 72044 0
+966543128555
Fax 72044 0
Email 72044 0
[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
SourceTitleYear of PublicationDOI
EmbaseSurgical management of colonic basidiobolomycosis among adolescent and adult patients: presentation and outcome.2018https://dx.doi.org/10.1111/codi.13939
N.B. These documents automatically identified may not have been verified by the study sponsor.