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Evaluation the effect of treatment by oral antibiotics in patients with pre-anal abscess in occurrence of anal fistula within 3 months post operation.

Protocol summary

Summary
Aims and pattern The most common complications of anorectal abscess are recurrence and fistula formation that happen after standard treatments including incision and drainage. Different participating factors in fistula formation after incision and drainage have been studied among age , sex, race, season of illness, personal hygiene, slow job, bowel habits, diabetes, microbiologic culture, abscess, kind of abscess, smoking, alcohol and pre operation consumption of antibiotics can be mentioned . Regarding to different opinions and high prevalence of disease we decided to compare fistula formation rate in patients receiving antibiotics after surgical treatment of uncomplicated abscess with the group with no given antibiotics . Different antibiotics has been tried in these conditions , but, not only the kind of antibiotics , but also the necessity of giving antibiotics after incision and drainage on anorectal abscess has been debated so far . Program and participants Based on the formula comparing two proportions the sample size has been determined 150 in each group . There are 150 patient in the first group - antibiotic receiving - and 150 in the second group whom were not given any antibiotics after operation ( Dividing method was based on the permutation blocks ) . Entry in study criteria Age between 16 and 65 – Perianal diagnosis made by general surgery resident – First time arrival with perianal diagnosis . Exclusion criteria Previous anal surgeries – co existing fistula – Inflammatory diseases of bowel – Previous radiation to pelvis – cellulites Interactions In control group : Patients with diagnosed perianal abscess undergo incision and drainage . They receive no additional treatment . In experiment group : Patients undergo incision and drainage and they will be given oral antibiotics ( Ciprofloxacin and Clindamycin ) 7 days after being discharged from hospital . Main consequent variables Fistula formation rate in the two groups - patient who take oral antibiotics and those who does not - in the time of being sent home after incision and drainage operations will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201311049936N7
Registration date: 2014-01-07, 1392/10/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-07, 1392/10/17
Registrant information
Name
Leila Ghahramani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 5586
Email address
lghahraman@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice –Chancellor for research, Shiraz University of Medical Sciences, Shiraz, Iran
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of treatment by oral antibiotics in patients with pre-anal abscess in occurrence of anal fistula within 3 months post operation.
Public title
Effect of treatment with oral antibiotics at discharge rates of anal fistula
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age older than 16 years and less than 65 years; peri-anal abscess diagnosed by a resident of anorectal surgery; the first patient was admitted because of anal abscess. Exclusion criteria: previous anal surgery; there fistula with abscess; inflammatory disease of the colon; history of pelvic radiation, cellulite; horseshoe abscesses; immunosuppression; diabetes mellitus; heart valve disease; prostheses; obesity; history of hypersensitivity to metronidazole and ciprofloxacin; ischiorectal abscess.
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Siences
Street address
Shiraz University of Medical Siences, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2013-06-29, 1392/04/08
Ethics committee reference number
4694-01-01-91

Health conditions studied

1

Description of health condition studied
Anal fistula
ICD-10 code
K60.3
ICD-10 code description
Anal fistula

Primary outcomes

1

Description
Anal fistula treatment with the use of oral antibiotics after discharge
Timepoint
Two weeks after surgery and initial evaluation of patients during the first three months of using oral antibiotics
Method of measurement
Feeding, The recovery rate, The fistula

Secondary outcomes

1

Description
Anal fistula treatment without the use of oral antibiotics after discharge
Timepoint
Two weeks after surgery and initial evaluation of patients during the first three months of using oral antibiotics
Method of measurement
Feeding, The recovery rate, The fistula

Intervention groups

1

Description
Control group: patients with perianal abscess under the standard surgical treatment (incision and drainage) are placed under additional treatment not covered.
Category
Treatment - Drugs

2

Description
Intervention group: patients with perianal abscess under the standard surgical treatment (incision and drainage) is placed at discharge for 7 days, oral antibiotics (ciprofloxacin and metronidazole) is prescribed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emergency Faqihi hospital, Shiraz, Iran
Full name of responsible person
Dr Leila Ghahramani- Assistant professor of General Surgery
Street address
Colorectal Research Center, Faghihi hospital, Shiraz, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice –Chancellor of Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Vice –Chancellor of Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice –Chancellor of Shiraz University of Medical Sciences, Shiraz, Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Colorectal Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Alireza Safarpour
Position
Assistant professor, fellowship of colorectal
Other areas of specialty/work
Street address
Colorectal Research Center,Shahid Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 1230 6972
Fax
Email
fsafrpour@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Colorectal Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Alireza Safarpour
Position
MD, MPH
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1230 6972
Fax
Email
fsafarpour@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Colorectal Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Leila Ghahramani
Position
Assistant Professor
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1230 6972
Fax
Email
leila_ghahramani@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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