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Protocol summary
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.
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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.
هدف اصلی از این تحقیق مقایسه بین دو روش پانسمان عادی و ژل مترونیدازول موضعی در التیام زخم هموروئید می باشد. مطالعه در بیمارانی که با هموروئید داخلی بدون عوارض به بیمارستان امام رضا بیرجند ارجاع می شوند انجام خواهد شد. عمده شرایط ورود به مطالعه عبارتند از رضایت آگاهانه؛ بیماران مبتلا به هموروئید داخلی بدون عارضه؛ سن بین 20 و 60 سال. حجم نمونه 200 نفر خواهد بود که مشارکت کنندگان به روش تخصیص تصادفی ساده به دو گروه مورد و شاهد تخصیص می یابند (در هر گروه 100 نفر). در گروه شاهد، ما پانسمان معمولی استفاده خواهیم کرد و در گروه مورد، از ژل مترونیدازول موضعی استفاده خواهد شد. بیمار و پرستار گردآورنده اطلاعات، از نوع پانسمان تجویز شده اطلاعی ندارد. برای اندازه گیری درد در بیماران از مقیاس پیوسته بصری در ساعت 6، 12، 24، 48 و روز 7 و 14 بعد از عمل جراحی استفاده خواهد کرد. یک جراح متخصص بیمار را در روزهای 3، 7، 14 و 21 پس از عمل جراحی به منظور بررسی درجه تشکیل بافت پوششی (اپیتلیزاسیون) معاینه خواهد کرد.
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هدف اصلی از این تحقیق مقایسه بین دو روش پانسمان عادی و ژل مترونیدازول موضعی در التیام زخم هموروئید می باشد. مطالعه در بیمارانی که با هموروئید داخلی بدون عوارض به بیمارستان امام رضا بیرجند ارجاع می شوند انجام خواهد شد. عمده شرایط ورود به مطالعه عبارتند از رضایت آگاهانه؛ بیماران مبتلا به هموروئید داخلی بدون عارضه؛ سن بین 20 و 60 سال. حجم نمونه 200 نفر خواهد بود که مشارکت کنندگان به روش تخصیص تصادفی ساده به دو گروه مورد و شاهد تخصیص می یابند (در هر گروه 100 نفر). در گروه شاهد، ما پانسمان معمولی استفاده خواهیم کرد و در گروه مورد، از ژل مترونیدازول موضعی استفاده خواهد شد. بیمار و پرستار گردآورنده اطلاعات، از نوع پانسمان تجویز شده اطلاعی ندارد. برای اندازه گیری درد در بیماران از مقیاس پیوسته بصری در ساعت 6، 12، 24، 48 و روز 7 و 14 بعد از عمل جراحی استفاده خواهد کرد. یک جراح متخصص بیمار را در روزهای 3، 7، 14 و 21 پس از عمل جراحی به منظور بررسی درجه تشکیل بافت پوششی (اپیتلیزاسیون) معاینه خواهد کرد.
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To compare the conventional dressing and topical metronidazole gel in wound healing of operated hemorrhoids
To compare the conventional dressing and topical metronidazole gel in wound healing of operated hemorrhoids
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مقایسه بین دو روش پانسمان عادی و ژل مترونیدازول موضعی در التیام زخم هموروئید
مقایسه بین دو روش پانسمان عادی و ژل مترونیدازول موضعی در التیام زخم هموروئید
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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).
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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حجم نمونه 112 نفر خواهد بود که مشارکت کنندگان به روش تخصیص تصادفی ساده به دو گروه مورد و شاهد تخصیص می یابند (در هر گروه 56 نفر).
حجم نمونه 112 نفر خواهد بود که مشارکت کنندگان به روش تخصیص تصادفی ساده به دو گروه مورد و شاهد تخصیص می یابند (در هر گروه 56 نفر).
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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.
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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مطالعه در بیمارانی که با هموروئید داخلی بدون عوارض به بیمارستان امام رضا بیرجند ارجاع می شوند انجام خواهد شد. بیمار و پرستار گردآورنده اطلاعات، از نوع پانسمان تجویز شده اطلاعی ندارد.
مطالعه در بیمارانی که با هموروئید داخلی بدون عوارض به بیمارستان امام رضا بیرجند ارجاع می شوند انجام خواهد شد. بیمار و پرستار گردآورنده اطلاعات، از نوع پانسمان تجویز شده اطلاعی ندارد.
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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.
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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عمده شرایط ورود به مطالعه عبارتند از رضایت آگاهانه؛ بیماران مبتلا به هموروئید داخلی بدون عارضه؛ سن بین 20 و 60 سال.
عمده شرایط خروج از مطالعه عبارتند از عدم تمایل به ادامه مشارکت؛ حضور بیماری پس زمینه ای (مانند فشار خون بالا، بیماری های قلبی عروقی، بیماری های ریوی، دیابت)؛ شقاق مقعد؛ و اعتیاد به مواد مخدر.
عمده شرایط ورود به مطالعه عبارتند از رضایت آگاهانه؛ بیماران مبتلا به هموروئید داخلی بدون عارضه؛ سن بین 20 و 60 سال. عمده شرایط خروج از مطالعه عبارتند از عدم تمایل به ادامه مشارکت؛ حضور بیماری پس زمینه ای (مانند فشار خون بالا، بیماری های قلبی عروقی، بیماری های ریوی، دیابت)؛ شقاق مقعد؛ و اعتیاد به مواد مخدر.
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In the control group, we will use conventional dressing and in the case group, we will use topical metronidazole gel.
In the control group, we will use conventional dressing and in the case group, we will use topical metronidazole gel.
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در گروه شاهد، ما پانسمان معمولی استفاده خواهیم کرد و در گروه مورد، از ژل مترونیدازول موضعی استفاده خواهد شد.
در گروه شاهد، ما پانسمان معمولی استفاده خواهیم کرد و در گروه مورد، از ژل مترونیدازول موضعی استفاده خواهد شد.
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Post-operative pain and the degree of epithelization will be assessed.
Post-operative pain and the degree of epithelization will be assessed.
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درد پس از عمل و میزان التیام بررسی خواهند شد.
درد پس از عمل و میزان التیام بررسی خواهند شد.
General information
1
1
1
1
Single
Parallel
singlparal
200
112
200112
Informed consent
patients with internal hemorrhoids without complication
age between 20 and 60 years
Informed consent patients with internal hemorrhoids without complication age between 20 and 60 years
رضایت آگاهانه
یماران مبتلا به هموروئید داخلی بدون عارضه
سن بین 20 و 60 سال
رضایت آگاهانه یماران مبتلا به هموروئید داخلی بدون عارضه سن بین 20 و 60 سال
Unwillingness to continue participation
presence of background diseases (such as hypertension, cardiovascular diseases, pulmonary diseases, diabetes mellitus)
anal fissure
addiction to drugs
fistula
abscesses
Unwillingness to continue participation presence of background diseases (such as hypertension, cardiovascular diseases, pulmonary diseases, diabetes mellitus) anal fissure addiction to drugs fistula abscesses
عدم تمایل به ادامه مشارکت
حضور بیماری پس زمینه ای (مانند فشار خون بالا، بیماری های قلبی عروقی، بیماری های ریوی، دیابت)
شقاق مقعد
اعتیاد به مواد مخدر
فیستول
آبسه
عدم تمایل به ادامه مشارکت حضور بیماری پس زمینه ای (مانند فشار خون بالا، بیماری های قلبی عروقی، بیماری های ریوی، دیابت) شقاق مقعد اعتیاد به مواد مخدر فیستول آبسه
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The participants were allocated into study groups using table of random numbers.
The participants were allocated into study groups using table of random numbers.
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مشارکت کنندگان با استفاده از جدول اعداد تصادفی به گروه های مطالعه تخصیص یافتند.
مشارکت کنندگان با استفاده از جدول اعداد تصادفی به گروه های مطالعه تخصیص یافتند.
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Neither the patient nor the nurse collecting the data will be informed of the dressing type applied.
Neither the patient nor the nurse collecting the data will be informed of the dressing type applied.
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بیمار و پرستار گردآورنده اطلاعات، از نوع پانسمان تجویز شده اطلاعی ندارد.
بیمار و پرستار گردآورنده اطلاعات، از نوع پانسمان تجویز شده اطلاعی ندارد.
Recruitment centers
#1
Name of recruitment center - English: Imam Reza Educational Hospital
Name of recruitment center - Persian: بیمارستان آموزشي امام رضا (ع)
Full name of responsible person - English: Dr. Seyed Amirkazem Vejdan
Full name of responsible person - Persian: دکتر سید امیرکاظم وجدان
Street address - English: Surgery Ward, Imam Reza Educational Hospital, Taleghani Street
Street address - Persian: خیابان طالقانی، بيمارستان آموزشی امام رضا، بخش جراحی
City - English: Birjand,
City - Persian: بیرجند
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Imam Reza Educational Hospital
Name of recruitment center - Persian: بیمارستان آموزشی امام رضا (ع)
Full name of responsible person - English: Dr. Seyed Amirkazem Vejdan
Full name of responsible person - Persian: دکتر سید امیرکاظم وجدان
Street address - English: Surgery Ward, Imam Reza Educational Hospital, Taleghani Street
Street address - Persian: خیابان طالقانی، بيمارستان آموزشی امام رضا، بخش جراحی
City - English: Birjand,
City - Persian: بیرجند
Province: South Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9717853577
Phone: +98 56 3222 2300
Fax:
Email: vejdan_sa@bums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza Educational Hospital Name of recruitment center - Persian: بیمارستان آموزشيآموزشی امام رضا (ع) Full name of responsible person - English: Dr. Seyed Amirkazem Vejdan Full name of responsible person - Persian: دکتر سید امیرکاظم وجدان Street address - English: Surgery Ward, Imam Reza Educational Hospital, Taleghani Street Street address - Persian: خیابان طالقانی، بيمارستان آموزشی امام رضا، بخش جراحی City - English: Birjand, City - Persian: بیرجند Province: South Khorasan Country: Iran (Islamic Republic of) Postal code: 9717853577 Phone: +98 56 3222 2300 Fax: Email: vejdan_sa@bums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice-Chancellery of Research and Technology at Birjand University of Medical Sciences
Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی بیرجند
Full name of responsible person - English: Dr. Tooba Kazemi
Full name of responsible person - Persian: دکتر طوبی کاظمی
Street address - English: Vice-chancellery of Reasearch and Technology, Birjand University of Medical Sciences, Ghaffari St.,
Street address - Persian: خیابان غفاری، دانشگاه علوم پزشکی بیرجند، معاونت تحقیقات و فناوری،
City - English: Birjand
City - Persian: بیرجند
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Tooba Kazemi
Full name of responsible person - Persian: دکتر طوبی کاظمی
Street address - English: Vice-chancellery of Reasearch and Technology, Birjand University of Medical Sciences, Ghaffari St.,
Street address - Persian: خیابان غفاری، دانشگاه علوم پزشکی بیرجند، معاونت تحقیقات و فناوری،
City - English: Birjand
City - Persian: بیرجند
Province: South Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9717853577
Phone: +98 56 3238 3200
Fax:
Email: dr.toobakazemi@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice-Chancellery of Research and Technology at Birjand University of Medical Sciences Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی بیرجند Full name of responsible person - English: Dr. Tooba Kazemi Full name of responsible person - Persian: دکتر طوبی کاظمی Street address - English: Vice-chancellery of Reasearch and Technology, Birjand University of Medical Sciences, Ghaffari St., Street address - Persian: خیابان غفاری، دانشگاه علوم پزشکی بیرجند، معاونت تحقیقات و فناوری، City - English: Birjand City - Persian: بیرجند Province: South Khorasan Country: Iran (Islamic Republic of) Postal code: 9717853577 Phone: +98 56 3238 3200 Fax: Email: dr.toobakazemi@gmail.com Web page address:
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Public
public
empty
Domestic
domestic
empty
Academic
academic
Vice-Chancellery of Research and Technology at Birjand University of Medical Sciences
Birjand University of Medical Sciences
Vice-Chancellery of Research and Technology at Birjand University of Medical Sciences
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی بیرجند
دانشگاه علوم پزشکی بیرجند
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی بیرجند
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Birjand University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي بيرجند
Full name of responsible person - English: Fahime Shirdel
Full name of responsible person - Persian: فهیمه شیردل
Position - English: Medical Student
Position - Persian: دانشجوی پزشکی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St.,
Street address - Persian: خیابان غفاری، دانشگاه علوم پزشکی، دانشکده پزشکی،
City - English: Birjand
City - Persian: بیرجند
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 56 3222 2300
Mobile: +98 915 160 5202
Fax:
Email: uni_ssh@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fahime Shirdel
Full name of responsible person - Persian: فهیمه شیردل
Position - English: Medical Student
Position - Persian: دانشجوی پزشکی
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St.
Street address - Persian: خیابان غفاری، دانشگاه علوم پزشکی، دانشکده پزشکی
City - English: Birjand
City - Persian: بیرجند
Province: South Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9717853577
Phone: +98 56 3222 2300
Mobile: +98 915 160 5202
Fax:
Email: uni_ssh@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Birjand University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشكي بيرجند Full name of responsible person - English: Fahime Shirdel Full name of responsible person - Persian: فهیمه شیردل Position - English: Medical Student Position - Persian: دانشجوی پزشکی Latest degree: med_doctor Area of specialty/work: 030 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St., Street address - Persian: خیابان غفاری، دانشگاه علوم پزشکی، دانشکده پزشکی، City - English: Birjand City - Persian: بیرجند Province: South Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9717853577 Phone: +98 56 3222 2300 Mobile: +98 915 160 5202 Fax: Email: uni_ssh@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Birjand University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی بیرجند
Full name of responsible person - English: Dr Seyed Amirkazem Vejdan
Full name of responsible person - Persian: دکتر سید امیرکاظم وجدان
Position - English: General Surgeon
Position - Persian: جراح عمومی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Surgery ward, Imam Reza Educational Hospital, Taleghani Street
Street address - Persian: خیابان طالقانی، بيمارستان آموزشی امام رضا (ع)، بخش جراحی
City - English: Birjand
City - Persian: بیرجند
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 56 3222 2300
Mobile: +98 915 161 3885
Fax:
Email: vejdan_sa@yahoo.com
Web page address: www.surgeryonweb.com
contact.organization_id:
Name of organization / entity - English: Birjand University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی بیرجند
Full name of responsible person - English: Dr Seyed Amirkazem Vejdan
Full name of responsible person - Persian: دکتر سید امیرکاظم وجدان
Position - English: General Surgeon
Position - Persian: جراح عمومی
Latest degree: specialist
Area of specialty/work: 36
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Surgery ward, Imam Reza Educational Hospital, Taleghani Street
Street address - Persian: خیابان طالقانی، بيمارستان آموزشی امام رضا (ع)، بخش جراحی
City - English: Birjand
City - Persian: بیرجند
Province: South Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9717853577
Phone: +98 56 3222 2300
Mobile: +98 915 161 3885
Fax:
Email: vejdan_sa@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Birjand University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی بیرجند Full name of responsible person - English: Dr Seyed Amirkazem Vejdan Full name of responsible person - Persian: دکتر سید امیرکاظم وجدان Position - English: General Surgeon Position - Persian: جراح عمومی Latest degree: specialist Area of specialty/work: 036 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Surgery ward, Imam Reza Educational Hospital, Taleghani Street Street address - Persian: خیابان طالقانی، بيمارستان آموزشی امام رضا (ع)، بخش جراحی City - English: Birjand City - Persian: بیرجند Province: South Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9717853577 Phone: +98 56 3222 2300 Mobile: +98 915 161 3885 Fax: Email: vejdan_sa@yahoo.com Web page address: www.surgeryonweb.com
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Birjand University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی بیرجند
Full name of responsible person - English: Fahime Shirdel
Full name of responsible person - Persian: فهیمه شیردل
Position - English: Medical Student
Position - Persian: دانشجوی پزشکی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Birjand University of Medical Sciences, Ghaffari St.,
Street address - Persian: خیابان غفاری، دانشگاه علوم پزشکی بیرجند،
City - English: Birjand
City - Persian: بیرجند
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 51 3244 3045
Mobile: +98 915 160 5202
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Birjand University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی بیرجند
Full name of responsible person - English: Fahime Shirdel
Full name of responsible person - Persian: فهیمه شیردل
Position - English: Medical Student
Position - Persian: دانشجوی پزشکی
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Birjand University of Medical Sciences, Ghaffari St.
Street address - Persian: خیابان غفاری، دانشگاه علوم پزشکی بیرجند
City - English: Birjand
City - Persian: بیرجند
Province: South Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9717853577
Phone: +98 51 3244 3045
Mobile: +98 915 160 5202
Fax:
Email: hadirooz@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Birjand University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی بیرجند Full name of responsible person - English: Fahime Shirdel Full name of responsible person - Persian: فهیمه شیردل Position - English: Medical Student Position - Persian: دانشجوی پزشکی Latest degree: med_doctor Area of specialty/work: 030 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Birjand University of Medical Sciences, Ghaffari St., Street address - Persian: خیابان غفاری، دانشگاه علوم پزشکی بیرجند، City - English: Birjand City - Persian: بیرجند Province: South Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9717853577 Phone: +98 51 3244 3045 Mobile: +98 915 160 5202 Fax: Email: hadirooz@gmail.com Web page address:
Sharing plan
undecided
undecided
yes
yes
yes
yes
yes
yes
yes
yes
na
na
na
na
empty
If there is a request, we will consider it.
If there is a request, we will consider it.
empty
در صورتیکه درخواستی برای این مهم باشد، ما آن را در نظر خواهیم گرفت.
در صورتیکه درخواستی برای این مهم باشد، ما آن را در نظر خواهیم گرفت.
empty
Deidentified IPD: If there is a request, we will consider it.
Deidentified IPD: If there is a request, we will consider it.
empty
داده های فردی شرکت کنندگان بدون نام: در صورتیکه درخواستی برای این مهم باشد، ما آن را در نظر خواهیم گرفت.
داده های فردی شرکت کنندگان بدون نام: در صورتیکه درخواستی برای این مهم باشد، ما آن را در نظر خواهیم گرفت.
empty
ُSince the time the extracted paper is published for 6 months
ُSince the time the extracted paper is published for 6 months
empty
از زمان انتشار مقاله مستخرج از طرح به مدت 6 ماه
از زمان انتشار مقاله مستخرج از طرح به مدت 6 ماه
empty
Researchers who are interested in this subject matter
Researchers who are interested in this subject matter
empty
پژوهشگرانی که علاقه مند به مطالعه در این زمینه هستند.
پژوهشگرانی که علاقه مند به مطالعه در این زمینه هستند.
empty
Applicants can present their requests via email of researchers as posited in the extracted paper.
Applicants can present their requests via email of researchers as posited in the extracted paper.
empty
درخواست می تواند از طریق ایمیل به نگارندگان مقاله مستخرج از طرح انجام پذیرد.
درخواست می تواند از طریق ایمیل به نگارندگان مقاله مستخرج از طرح انجام پذیرد.
empty
Via personal correspondence
Via personal correspondence
empty
از طریق رایانامه
از طریق رایانامه
empty
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.
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.
empty
متقاطی داده های بی نام بایستی از طریق رایانامه، جزییات طرح پیشروی خود را ارایه نماید. داده ها ظرف مدت یک هفته از زمان درخواست در دسترس خواهند بود.
متقاطی داده های بی نام بایستی از طریق رایانامه، جزییات طرح پیشروی خود را ارایه نماید. داده ها ظرف مدت یک هفته از زمان درخواست در دسترس خواهند بود.
Protocol summary
Study aim
To compare the conventional dressing and topical metronidazole gel in wound healing of operated hemorrhoids
Design
The sample size is 112 patients who will be allocated into case and control groups via randomized allocation method (n=56 per group).
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
In the control group, we will use conventional dressing and in the case group, we will use topical metronidazole gel.
Main outcome variables
Post-operative pain and the degree of epithelization will be assessed.
General information
Reason for update
Acronym
IRCT registration information
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
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
Participant
Investigator
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were allocated into study groups using table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Neither the patient nor the nurse collecting the data will be informed of the dressing type applied.
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
Province
South Khorasan
Postal code
9717853577
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,
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Email
vejdan_sa@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 3200
Email
dr.toobakazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
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
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
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
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Surgery ward, Imam Reza Educational Hospital, Taleghani Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Fax
Email
vejdan_sa@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
Fahime Shirdel
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 51 3244 3045
Fax
Email
hadirooz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified IPD: If there is a request, we will consider it.
When the data will become available and for how long
ُSince the time the extracted paper is published for 6 months
To whom data/document is available
Researchers who are interested in this subject matter
Under which criteria data/document could be used
Applicants can present their requests via email of researchers as posited in the extracted paper.
From where data/document is obtainable
Via personal correspondence
What processes are involved for a request to access data/document
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.