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Trial registered on ANZCTR


Registration number
ACTRN12614001093673
Ethics application status
Approved
Date submitted
28/09/2014
Date registered
15/10/2014
Date last updated
15/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Does giving antibiotics or not after draining acute perianal abscess in adult patients affect further anal fistula formation? A prospective randomized controlled trial.
Scientific title
Comparison between giving antibiotics and not giving antibiotics after draining acute perianal abscess in adults in terms of anal fistula formation. A prospective randomized controlled trial.
Secondary ID [1] 285410 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peri Anal Abscess 293158 0
Condition category
Condition code
Surgery 293431 293431 0 0
Other surgery
Infection 293503 293503 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be operated in Lithotomy position. Anaesthesia whether spinal or general will be determined by the patients and anaesthetist preference and according to patients’s general condition. Examination under anaesthesia will be done first, the area of the abscess will be cleaned with povidone iodine. An alcohol swab will be used to disinfect the area of aspiration. A 10 cm syringe will be used for aspiration of a sample from abscess contents and will be sent for culture and sensitivity study after which abscess will be incised and drained.Patients will be allocated randomly (using closed envelope technique) into two groups: Group A for patients who will receive oral metronidazole (500mg, three times daily TDS for for 3 days , then same antibiotic may be continued for another 4 days or different antibiotic may be given based on results of culture and sensitivity of aspiration sample) as post operative antibiotic. Type of antibiotic will be changed after three days according to the results of the culture and sensitivity of the pus sample taken from the abscess. Patients will be followed up at 1,3,6, and 12 months to detect anal fistula formation.
Intervention code [1] 290329 0
Treatment: Drugs
Intervention code [2] 290393 0
Prevention
Comparator / control treatment
group B for patients will not receive postoperative antibiotics. Patients will be followed up at 1,3,6, and 12 months to detect anal fistula formation.
Control group
Active

Outcomes
Primary outcome [1] 293253 0
Anal Fistula formation
Timepoint [1] 293253 0
By examination by the doctor (blinded) in outpatient clinic at 1,3,6,and 12 months post operatively and diagnosis will depend on creation of anal fistula at the same site of preexisting perianal abscess.
Secondary outcome [1] 310680 0
nil
Timepoint [1] 310680 0
nil

Eligibility
Key inclusion criteria
All adult patients complaining of perianal abscess presented to ER department of Aseer Central Hospital and Najran Hospital will be included in this study. Diagnosis of peri anal abscess will be on clinical bases.
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Patients with already formed anal fistula (as the outcome will not be valid)
*Patients with pelvi-rectal abscess (as the approach of surgery is different)
*Patients with known compromised immune state as DM, malignancy or receiving steroid therapy (as these people require antibiotic coverage to prevent serious complications)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
closed envelope technique
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
One hundred opaque envelope will contain 50 group A and 50 Group B will be prepared and shuffled (in each hospital 25 for each group). An operative nurse with no relation to the research will choose an envelope and inform a resident (not involved in the research) who will prescribe the post operative treatment for the patient without informing the surgeon
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size was calculated to be 44 patients (90% power). It was determined based on the Epi info Statcalc version 6(1993) statistical program with a assuming incidence of fistula formation from 38%-50%.
t test will be used to compare between the two groups

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/10/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment outside Australia
Country [1] 6380 0
Saudi Arabia
State/province [1] 6380 0
Abha/Najran

Funding & Sponsors
Funding source category [1] 290016 0
Self funded/Unfunded
Name [1] 290016 0
Country [1] 290016 0
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] 288704 0
Hospital
Name [1] 288704 0
Aseer Central Hospital
Address [1] 288704 0
King Abdullah Road
PO Box 34
Zip: 62523
Abha
Saudi Arabia
Country [1] 288704 0
Saudi Arabia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51750 0
A/Prof Walid Abd El Maksoud MD, MRCS
Address 51750 0
King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641
Country 51750 0
Saudi Arabia
Phone 51750 0
+966543128555
Fax 51750 0
Email 51750 0
[email protected]
Contact person for public queries
Name 51751 0
Walid Abd El Maksoud MD, MRCS
Address 51751 0
King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641
Country 51751 0
Saudi Arabia
Phone 51751 0
+966543128555
Fax 51751 0
Email 51751 0
[email protected]
Contact person for scientific queries
Name 51752 0
Walid Abd El Maksoud MD, MRCS
Address 51752 0
King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641
Country 51752 0
Saudi Arabia
Phone 51752 0
+966543128555
Fax 51752 0
Email 51752 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
No additional documents have been identified.