Protocol summary

Summary
This clinical trial compares the effects of postoperative prescription or non-prescription of antibiotics on reduction of infection in patients operated for simple appendicitis in the surgery ward of Imam Reza Hospital of Birjand. The study is a single-blind randomized controlled trial with case and control groups where the participants will be unaware to which group they belong. The participants will include a total of 150 patients operated for acute appendicitis who lack chronic underlying disease and have a body mass index below 25. They will be allocated into case and control groups through simple randomization method so that everybody would have a similar chance of belonging to either the intervention or control groups. Both groups will receive antibiotics preoperatively, including ceftriaxone and metronidazole. Ceftriaxone will be prescribed in1 gram for adults and 50 mg per kg on a daily basis for children. Metronidazole will be prescribed 500 mg for adults and 35 mg per kg on a daily basis for children. Postoperatively, the cases will continue to take the antibiotics for 24 hours, while the controls will not receive any antibiotics. All patients will be followed during hospitalization and up to 14 days after surgery. They will be visited once a week after discharge (first and second weeks after surgery) by the surgeon in a clinic. The two groups will be examined with regard to infectious complications including wound infection, abdominal abscess, pelvic abscess, fever, and wound repair.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031617756N12
Registration date: 2017-03-29, 1396/01/09
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-29, 1396/01/09
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery for Research at Birjand University of Medical Sciences
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2017-06-01, 1396/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of post-operative prescription or non-prescription of ceftriaxone and metronidazole on infection reduction of patients operated with simple appendicitis: A clinical trial
Public title
Effects of antibiotics on infection reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 15 and 75 years; patients who have undergone surgery for acute appendicitis; patients with a and body mass index lower than 25; absence of advanced appendicitis (i.e., gangrene, perforation, peritonitis, or phlegmon) or normal appendicitis; lack of severe underlying or chronic diseases such as diabetes. Exclusion criteria: Unwillingness to continue participation
Age
From 15 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice-chancellery of Research and Technology, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
9717853577
Approval date
2017-02-12, 1395/11/24
Ethics committee reference number
Ir.bums.rec.1395.283

Health conditions studied

1

Description of health condition studied
Infection complications
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure, not elsewhere classified

Primary outcomes

1

Description
Wound infection
Timepoint
During hospitalization, first and second weeks after operation
Method of measurement
Physical examination

2

Description
Abdominal abscess
Timepoint
During hospitalization, first and second weeks after operation
Method of measurement
Physical examination and, if needed, by ultrasonography

3

Description
Pelvic abscess
Timepoint
During hospitalization, first and second weeks after operation
Method of measurement
Physical examination and, if needed, by ultrasonography

Secondary outcomes

1

Description
Fever
Timepoint
During hospitalization
Method of measurement
Thermometer

Intervention groups

1

Description
Control Group: They will receive antibiotics preoperatively, including ceftriaxone and metronidazole. Ceftriaxone will be prescribed as 1 gram for adults and 50 mg/kg/day for children. Metronidazole will be prescribed 500 mg for adults and 35 mg/kg for children. Postoperatively, the controls will not take any antibiotics.
Category
Treatment - Drugs

2

Description
Intervention group: They will receive antibiotics preoperatively, including ceftriaxone and metronidazole. Ceftriaxone will be prescribed as 1 gram for adults and 50 mg/kg/day for children. Metronidazole will be prescribed 500 mg for adults and 35 mg/kg for children. Postoperatively, the cases will continue to take the antibiotics for 24 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Sahar Samimi
Street address
Surgery ward, Imam Reza Hospital, Taleghani St.,
City
Birjand,

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology at Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Vice-chancellery of Reasearch and Technology, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology at Birjand University of Medical Sciences
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
Birjand University of Medical Sciences
Full name of responsible person
Sahar Samimi
Position
Medical Student
Other areas of specialty/work
Street address
No. 30, Nasr St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
Saharsamimi65@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sahar Samimi
Position
Student of Medicine
Other areas of specialty/work
Street address
Faculty of Medicine, Birjand University of Medical Sciecnes, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
Saharsamimi65@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Vive-chancellery of Education, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
hadirooz@gmail.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
empty
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