Protocol summary
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Study aim
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To compare the conventional dressing and topical metronidazole gel in wound healing of operated hemorrhoids
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Design
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The sample size is 112 patients who will be allocated into case and control groups via randomized allocation method (n=56 per group).
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Settings and conduct
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This study will be performed on patients referred to the Birjand-based Imam Reza Hospital with internal hemorrhoid without complications. Neither the patient nor the nurse collecting the data will be informed of the dressing type applied.
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Participants/Inclusion and exclusion criteria
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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.
Major exclusion criteria involve unwillingness to continue participation; presence of background diseases (such as hypertension, cardiovascular diseases, pulmonary diseases, diabetes mellitus); anal fissure; and addiction to drugs.
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Intervention groups
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In the control group, we will use conventional dressing and in the case group, we will use topical metronidazole gel.
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Main outcome variables
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Post-operative pain and the degree of epithelization will be assessed.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201604108375N9
Registration date:
2017-08-06, 1396/05/15
Registration timing:
registered_while_recruiting
Last update:
2018-01-22, 1396/11/02
Update count:
1
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Registration date
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2017-08-06, 1396/05/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice-chancellery for Research of Birjand University of Medical Sciences
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Expected recruitment start date
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2017-07-23, 1396/05/01
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Expected recruitment end date
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2018-03-21, 1397/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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A clinical trial comparing topical Metronidazole gel and conventional dressing on wound healing after hemorrhoidectomy
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Public title
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Effects of topical Metronidazole gel and conventional dressing on wound healing
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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Sample size
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Target sample size:
112
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The participants were allocated into study groups using table of random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Neither the patient nor the nurse collecting the data will be informed of the dressing type applied.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-07-22, 1396/04/31
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Ethics committee reference number
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IR.BUMS.REC.1396.118
Health conditions studied
1
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Description of health condition studied
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Internal haemorrhoids without complication
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ICD-10 code
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I84.2
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ICD-10 code description
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Internal haemorrhoids NOS
Primary outcomes
1
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Description
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Wound healing
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Timepoint
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Days 3, 7, 14 and 21 after the intervention
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Method of measurement
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Physical examination for epithelization
Secondary outcomes
1
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Description
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Pain severity
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Timepoint
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6, 12, 24, and 48 hours and days 7 and 14 after the intervention
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Birjand University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Deidentified IPD: If there is a request, we will consider it.
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When the data will become available and for how long
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ُSince the time the extracted paper is published for 6 months
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To whom data/document is available
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Researchers who are interested in this subject matter
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Under which criteria data/document could be used
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Applicants can present their requests via email of researchers as posited in the extracted paper.
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From where data/document is obtainable
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Via personal correspondence
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What processes are involved for a request to access data/document
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An applicant should provide details of the research project undertaken by him/her via email to us. Within a week, the data may be provided.
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Comments
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