The main purpose of this investigation is to compare the conventional dressing and topical metronidazole gel in wound healing of operated hemorrhoids. This study will be performed on patients referred to the Birjand-based Imam Reza Hospital with internal hemorrhoid without complications. The main inclusion criteria consist of informed consent; patients with internal hemorrhoids without complication; and age between 20 and 60 years. The sample size is 200 patients who will be allocated into case and control groups via randomized allocation method (n=100 per group). In the control group, we will use conventional dressing and in the case group, we will use topical metronidazole gel. Neither the patient nor the nurse collecting the data will be informed of the dressing type applied. Visual Analogue Scale will be employed to measure pain in the patients 6, 12, 24, and 48 hours as well as days 7 and 14 after surgery. An expert surgeon will visit the patient on the days 3, 7, 14 and 21 after surgery to evaluate the degree of epithelization.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604108375N9
Registration date:2017-08-06, 1396/05/15
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-08-06, 1396/05/15
Registrant information
Name
Seyed Amirkazem Vejdan
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3222 2300
Email address
vejdan_sa@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery for Research of Birjand University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing topical Metronidazole gel and conventional dressing on wound healing after hemorrhoidectomy
Public title
Effects of topical Metronidazole gel and conventional dressing on wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent; patients with internal hemorrhoids without complication; age between 20 and 60 years.
Exclusion criteria: Unwillingness to continue participation; presence of background diseases (such as hypertension, cardiovascular diseases, pulmonary diseases, diabetes mellitus); anal fissure; addiction to drugs; fistula; abscesses.
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
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
Approval date
2017-07-22, 1396/04/31
Ethics committee reference number
IR.BUMS.REC.1396.118
Health conditions studied
1
Description of health condition studied
Internal haemorrhoids without complication
ICD-10 code
I84.2
ICD-10 code description
Internal haemorrhoids NOS
Primary outcomes
1
Description
Wound healing
Timepoint
Days 3, 7, 14 and 21 after the intervention
Method of measurement
Physical examination for epithelization
Secondary outcomes
1
Description
Pain severity
Timepoint
6, 12, 24, and 48 hours and days 7 and 14 after the intervention
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group (Topical Metronidazole gel dressing): In the case group, topical metronidazole gel will be applied in wound healing of operated hemorrhoids. Visual Analogue Scale will be employed to measure pain and an expert surgeon will visit the patient to evaluate the degree of epithelization.
Category
Treatment - Other
2
Description
Control Group (Traditional wound dressing): In the control group, we will use conventional dressing. Visual Analogue Scale will be employed to measure pain and an expert surgeon will visit the patient to evaluate the degree of epithelization.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Educational Hospital
Full name of responsible person
Dr. Seyed Amirkazem Vejdan
Street address
Surgery Ward, Imam Reza Educational Hospital, Taleghani Street
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
Fahime Shirdel
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand
Postal code
Phone
+98 56 3222 2300
Fax
Email
uni_ssh@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
Dr Seyed Amirkazem Vejdan
Position
General Surgeon
Other areas of specialty/work
Street address
Surgery ward, Imam Reza Educational Hospital, Taleghani Street
City
Birjand
Postal code
Phone
+98 56 3222 2300
Fax
Email
vejdan_sa@yahoo.com
Web page address
www.surgeryonweb.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fahime Shirdel
Position
Medical Student
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand
Postal code
Phone
+98 51 3244 3045
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)