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Protocol summary
The main objective of this study is determination of alterations in serum level of inflammatory markers among patients with femoral fracture under early versus late surgery. Inclusion criteria include fracture of femoral shaft and aging from 20 to 50 years without injury to other organs and the exclusion criteria are lack of satisfaction for incorporation in the study and concomitant injuries, and chronic inflammatory diseases. Understudy population are those patients under surgery for femoral fracture which include 38 subjects in to groups 0f 19 patients. The patients would be randomly assigned to undergo either early (first 24-hour) or late (after 24 hour) surgery by block randomization method. The serum level of interferon Gamma and interleukins 1, 5, and 6, and TNF-Alpha would be measured at baseline and after one hour from surgery. These will be compared across the groups.
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The main objective of this study is determination of alterations in serum level of inflammatory markers among patients with femoral fracture under early versus late surgery. Inclusion criteria include fracture of femoral shaft and aging from 20 to 50 years without injury to other organs and the exclusion criteria are lack of satisfaction for incorporation in the study and concomitant injuries, and chronic inflammatory diseases. Understudy population are those patients under surgery for femoral fracture which include 38 subjects in to groups 0f 19 patients. The patients would be randomly assigned to undergo either early (first 24-hour) or late (after 24 hour) surgery by block randomization method. The serum level of interferon Gamma and interleukins 1, 5, and 6, and TNF-Alpha would be measured at baseline and after one hour from surgery. These will be compared across the groups.
هدف از اين مطالعه تعيين میزان تغییرات مارکرهای التهابی سرمی در بیماران تحت درمان جراحی زودرس و دیررس برای شکستگی فمور مي باشد. معيارهای ورود به مطالعه شامل سنین 20 تا 50 سال و شکستگی شفت فمور ساده بدون آسیب همزمان در سایر نواحی بدن مي باشند و معيارهاي خروج شامل عدم رضايت براي شركت در مطالعه و وجود آسیب همزمان در سایر نواحی بدن و ابتلا به بيماري التهابي مزمن هستند. جمعيت مورد مطالعه بيماران تحت درمان جراحي براي شكستگي فمور مي باشند و در كل 38 نفر در دو گروه 19 نفري بررسي مي شوند. بیماران مذكور، تحت درمان به شیوه جراحی قرار می گیرند كه افراد به طور تصادفی با استفاده از متد Block Randomization در یکی از دو گروه جراحی زودرس (قبل از 24 ساعت) و دیررس (بعد از 24 ساعت) قرار می گیرند و در هر دو گروه سطح سرمی مارکرهای التهابی شامل اینترلوکین های 1، 5 و 6 و TNF-Alpha و اینترفرون گاما به وسیله کیت مخصوص در Baseline و نیز در فاز 1 ساعت پس از عمل جراحی تعیین می گردد و در بين دو گروه مورد مقایسه واقع می شود.
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هدف از اين مطالعه تعيين میزان تغییرات مارکرهای التهابی سرمی در بیماران تحت درمان جراحی زودرس و دیررس برای شکستگی فمور مي باشد. معيارهای ورود به مطالعه شامل سنین 20 تا 50 سال و شکستگی شفت فمور ساده بدون آسیب همزمان در سایر نواحی بدن مي باشند و معيارهاي خروج شامل عدم رضايت براي شركت در مطالعه و وجود آسیب همزمان در سایر نواحی بدن و ابتلا به بيماري التهابي مزمن هستند. جمعيت مورد مطالعه بيماران تحت درمان جراحي براي شكستگي فمور مي باشند و در كل 38 نفر در دو گروه 19 نفري بررسي مي شوند. بیماران مذكور، تحت درمان به شیوه جراحی قرار می گیرند كه افراد به طور تصادفی با استفاده از متد Block Randomization در یکی از دو گروه جراحی زودرس (قبل از 24 ساعت) و دیررس (بعد از 24 ساعت) قرار می گیرند و در هر دو گروه سطح سرمی مارکرهای التهابی شامل اینترلوکین های 1، 5 و 6 و TNF-Alpha و اینترفرون گاما به وسیله کیت مخصوص در Baseline و نیز در فاز 1 ساعت پس از عمل جراحی تعیین می گردد و در بين دو گروه مورد مقایسه واقع می شود.
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The main purpose of this study is determination of alterations in serum level of inflammatory markers of interferon Gamma and interleukins 1, 5, and 6, and TNF-Alpha that would be measured at baseline and after one hour from surgery among patients with femoral fracture under early versus late surgery.
The main purpose of this study is determination of alterations in serum level of inflammatory markers of interferon Gamma and interleukins 1, 5, and 6, and TNF-Alpha that would be measured at baseline and after one hour from surgery among patients with femoral fracture under early versus late surgery.
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هدف از اين مطالعه تعيين میزان تغییرات مارکرهای التهابی سرم شامل اینترلوکین های 1، 5 و 6 و TNF-Alpha و اینترفرون گاما به وسیله کیت مخصوص در Baseline و نیز در فاز 1 ساعت پس از عمل جراحی در بیماران تحت درمان جراحی زودرس و دیررس برای شکستگی فمور مي باشد.
هدف از اين مطالعه تعيين میزان تغییرات مارکرهای التهابی سرم شامل اینترلوکین های 1، 5 و 6 و TNF-Alpha و اینترفرون گاما به وسیله کیت مخصوص در Baseline و نیز در فاز 1 ساعت پس از عمل جراحی در بیماران تحت درمان جراحی زودرس و دیررس برای شکستگی فمور مي باشد.
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Randomised, superiority, parallel group trial with blinded outcome assessment
Randomised, superiority, parallel group trial with blinded outcome assessment
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کارآزمایی بالینی دو سویه کور و تصادفی شده
کارآزمایی بالینی دو سویه کور و تصادفی شده
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Rasool Hospital , Sattarkhan Street
Rasool Hospital , Sattarkhan Street
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بيمارستان رسول اكرم ، خيابان ستارخان
بيمارستان رسول اكرم ، خيابان ستارخان
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Inclusion criteria: Fracture of femoral shaft and aging from 20 to 50 years
Inclusion criteria: Fracture of femoral shaft and aging from 20 to 50 years
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سنین 20 تا 50 سال، شکستگی ساده شفت فمور، عدم وجود آسیب همزمان در سایر نواحی بدن
سنین 20 تا 50 سال، شکستگی ساده شفت فمور، عدم وجود آسیب همزمان در سایر نواحی بدن
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Patients with femoral fracture in the 2 groups were under the same surgery, before 24 hours of the visit to the hospital and after 24 hours of a visit to the hospital
Patients with femoral fracture in the 2 groups were under the same surgery, before 24 hours of the visit to the hospital and after 24 hours of a visit to the hospital
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بیماران با شکستگی فمور در 2 گروه تحت عمل جراحی یکسان قرار گرفتند ، قبل از 24 ساعت از مراجعه به بیمارستان و بعد از 24 ساعت از مراجعه به بیمارستان
بیماران با شکستگی فمور در 2 گروه تحت عمل جراحی یکسان قرار گرفتند ، قبل از 24 ساعت از مراجعه به بیمارستان و بعد از 24 ساعت از مراجعه به بیمارستان
Fracture of femoral shaft
no any other concomitant injury
aging from 20 to 50 years
Fracture of femoral shaft no any other concomitant injury aging from 20 to 50 years
سنین 20 تا 50 سال
عدم وجود آسیب همزمان در سایر نواحی بدن معيارهاي
شکستگی ساده شفت فمور
سنین 20 تا 50 سال عدم وجود آسیب همزمان در سایر نواحی بدن معيارهاي شکستگی ساده شفت فمور
Presence of concomitant injuries
presence of chronic inflammatory diseases
Presence of concomitant injuries presence of chronic inflammatory diseases
وجود آسیب همزمان در سایر نواحی بدن
وجود بيماري التهابي مزمن
وجود آسیب همزمان در سایر نواحی بدن وجود بيماري التهابي مزمن
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simple randomization
simple randomization
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تصادفی سازی ساده
تصادفی سازی ساده
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double blind , That is not the patient knew which group under the surgery and not see any sick doctor knew when and what time the surgery group
double blind , That is not the patient knew which group under the surgery and not see any sick doctor knew when and what time the surgery group
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کور سازی دوسویه ، به صورتی که نه بیمار میدانست در کدام گروه تحت عمل جراحی قرار میگیرد و نه پزشک میدانست هر مریض چه موقع مراجعه کرده است و در کدام گروه زمانی تحت عمل جراحی قرار میگیرد
کور سازی دوسویه ، به صورتی که نه بیمار میدانست در کدام گروه تحت عمل جراحی قرار میگیرد و نه پزشک میدانست هر مریض چه موقع مراجعه کرده است و در کدام گروه زمانی تحت عمل جراحی قرار میگیرد
Secondary outcomes
#1
IL 1,5, 6 & TNF-Alpha, IFN-Gamma
Interlukin 1
IL 1,5, 6 & TNF-Alpha, IFN-GammaInterlukin 1
مارکرهای التهابی شامل اینترلوکین های 1، 5 و 6 و TNF-Alpha و اینترفرون گاما
اینترلوکین 1
مارکرهای التهابی شامل اینترلوکین های 1، 5 و 6 و TNF-Alpha و اینترفرون گاما
#2
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IFN-Gamma
IFN-Gamma
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اینترفرون گاما
اینترفرون گاما
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One hour after surgery
One hour after surgery
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1 ساعت پس از عمل جراحي
1 ساعت پس از عمل جراحي
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lab kit
lab kit
empty
كيت آزمايشگاهي
كيت آزمايشگاهي
#3
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TNF-Alpha
TNF-Alpha
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تی ان اف آلفا
تی ان اف آلفا
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one hour after surgery
one hour after surgery
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1 ساعت پس از عمل جراحي
1 ساعت پس از عمل جراحي
empty
lab kit
lab kit
empty
كيت آزمايشگاهي
كيت آزمايشگاهي
#4
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interlukin 5
interlukin 5
empty
اینترلوکین 5
اینترلوکین 5
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one hour after surgery
one hour after surgery
empty
1 ساعت پس از عمل جراحي
1 ساعت پس از عمل جراحي
empty
lab kit
lab kit
empty
كيت آزمايشگاهي
كيت آزمايشگاهي
#5
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interlukin 6
interlukin 6
empty
اینترلوکین 6
اینترلوکین 6
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one hour after surgery
one hour after surgery
empty
1 ساعت پس از عمل جراحي
1 ساعت پس از عمل جراحي
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lab kit
lab kit
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كيت آزمايشگاهي
كيت آزمايشگاهي
Intervention groups
#1
Femoral Surgery
all patients with fractures of the femur bone that before 24 hours of admission to the emergency room, a common method of surgery are located and The fracture is fixed only by the plate
Femoral Surgeryall patients with fractures of the femur bone that before 24 hours of admission to the emergency room, a common method of surgery are located and The fracture is fixed only by the plate
جراحي شفت فمور كه به صورت فيكساسيون داخلي شكستگي در هر دو گروه انجام مي شود.
جراحي شفت فمور كه به صورت فيكساسيون داخلي شكستگي در هر گروه انجام مي شود ، به عبارتی همه ی بیماران با شکستگی استخوان فمور که قبل از 24 ساعت از ورود به اورژانس ، تحت عمل جراحی به یک روش مشترک قرار میگیرند و شکستگی تنها توسط پلیت فیکس میگردد
جراحي شفت فمور كه به صورت فيكساسيون داخلي شكستگي در هر دو گروه انجام مي شود. ، به عبارتی همه ی بیماران با شکستگی استخوان فمور که قبل از 24 ساعت از ورود به اورژانس ، تحت عمل جراحی به یک روش مشترک قرار میگیرند و شکستگی تنها توسط پلیت فیکس میگردد
#2
A group of the patients would undergo eraly surgery (before 24 hours) and in another group it will be performed as late (after 24 hours).
all patients with fractures of the femur bone that After 24 hours of admission to the emergency room, a common method of surgery are located and The fracture is fixed only by the plate
A groupall patients with fractures of the patients would undergo eraly surgery (beforefemur bone that After 24 hours) of admission to the emergency room, a common method of surgery are located and in another group it will be performed as late (after 24 hours).The fracture is fixed only by the plate
در يك گروه جراحي به صورت زودرس (قبل از 24 ساعت) و در يك گروه به صورت ديررس (بعد از 24 ساعت) انجام مي شود.
جراحي شفت فمور كه به صورت فيكساسيون داخلي شكستگي در هر گروه انجام مي شود ، به عبارتی همه ی بیماران با شکستگی استخوان فمور که بعد از 24 ساعت از ورود به اورژانس ، تحت عمل جراحی به یک روش مشترک قرار میگیرند و شکستگی تنها توسط پلیت فیکس میگردد
در يك گروه جراحي شفت فمور كه به صورت زودرس (قبل از 24 ساعت) وفيكساسيون داخلي شكستگي در يكهر گروه انجام مي شود ، به صورت ديررس (عبارتی همه ی بیماران با شکستگی استخوان فمور که بعد از 24 ساعت) انجام مي شود. از ورود به اورژانس ، تحت عمل جراحی به یک روش مشترک قرار میگیرند و شکستگی تنها توسط پلیت فیکس میگردد
Recruitment centers
#1
Name of recruitment center - English: Rasool Hospital
Name of recruitment center - Persian: بيمارستان رسول اكرم
Full name of responsible person - English: Dr. Otoukesh
Full name of responsible person - Persian: دكتر اتوكش
Street address - English:
Street address - Persian:
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Rasool Hospital
Name of recruitment center - Persian: بيمارستان رسول اكرم
Full name of responsible person - English: Dr.Babak Otoukesh
Full name of responsible person - Persian: دكتر بابک اتوكش
Street address - English: sattarkhan street
Street address - Persian: خیابان ستارخان، خیابان مازیار منصوری، بیمارستان رسول اکرم (ص)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6655 9595
Fax:
Email: babak.otoukesh@gmail.com
Web page address:
Name of recruitment center - English: Rasool Hospital Name of recruitment center - Persian: بيمارستان رسول اكرم Full name of responsible person - English: Dr.Dr.Babak Otoukesh Full name of responsible person - Persian: دكتر بابک اتوكش Street address - English: sattarkhan street Street address - Persian: خیابان ستارخان، خیابان مازیار منصوری، بیمارستان رسول اکرم (ص) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6655 9595 Fax: Email: babak.otoukesh@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي ايران
Full name of responsible person - English: Financial Department
Full name of responsible person - Persian: امور مالي دانشگاه
Street address - English: Hemmat Exp Way, Tehran
Street address - Persian: تهران، اتوبان همت، دانشگاه علوم پزشكي ايران
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي ايران
Full name of responsible person - English: Financial Department
Full name of responsible person - Persian: امور مالي دانشگاه
Street address - English: Hemmat Exp Way, Tehran
Street address - Persian: تهران، اتوبان همت، دانشگاه علوم پزشكي ايران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 86701
Fax:
Email: PR@iums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Iran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشكي ايران Full name of responsible person - English: Financial Department Full name of responsible person - Persian: امور مالي دانشگاه Street address - English: Hemmat Exp Way, Tehran Street address - Persian: تهران، اتوبان همت، دانشگاه علوم پزشكي ايران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 86701 Fax: Email: PR@iums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
دانشگاه علوم پزشكي ايران
دانشگاه علوم پزشکی ایران
دانشگاه علوم پزشكي ايرانپزشکی ایران
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Rasool Hspital
Name of organization / entity - Persian: بيمارستان رسول اكرم
Full name of responsible person - English: Dr. Babak Otoukesh
Full name of responsible person - Persian: دكتر بابك اتوكش
Position - English: Orthopedics Surgeon
Position - Persian: متخصص ارتوپدي
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Sattarkhan Street, Rasool Hospital, Tehran, Iran
Street address - Persian: تهران، خيابان ستارخان، بيمارستان رسول اكرم
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +216 6516001
Mobile: 00
Fax:
Email: babak_otoukesh@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Babak Otoukesh
Full name of responsible person - Persian: دكتر بابك اتوكش
Position - English: Orthopedics Surgeon
Position - Persian: متخصص ارتوپدي
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Sattarkhan Street, Rasool Hospital, Tehran, Iran
Street address - Persian: تهران، خيابان ستارخان، بيمارستان رسول اكرم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +216 6516001
Mobile: +98 912 684 3678
Fax:
Email: babak.otoukesh@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Rasool Hspital Name of organization / entity - Persian: بيمارستان رسول اكرم Full name of responsible person - English: Dr. Babak Otoukesh Full name of responsible person - Persian: دكتر بابك اتوكش Position - English: Orthopedics Surgeon Position - Persian: متخصص ارتوپدي Latest degree: specialist Area of specialty/work: 04 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Sattarkhan Street, Rasool Hospital, Tehran, Iran Street address - Persian: تهران، خيابان ستارخان، بيمارستان رسول اكرم City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +216 6516001 Mobile: 00+98 912 684 3678 Fax: Email: babak_otoukeshbabak.otoukesh@yahoo.comgmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Rasool Hospital
Name of organization / entity - Persian: بيمارستان رسول
Full name of responsible person - English: Babak Otoukesh
Full name of responsible person - Persian: بابك اتوكش
Position - English: Orthopedic Surgeon
Position - Persian: متخصص ارتوپدي
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Sattarkhan Street, Tehran, Iran
Street address - Persian: تهران، خيابان ستارخان
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +216 6516001
Mobile: 00
Fax:
Email: babak_otoukesh@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Rasool Hospital
Name of organization / entity - Persian: بيمارستان رسول
Full name of responsible person - English: Babak Otoukesh
Full name of responsible person - Persian: بابك اتوكش
Position - English: Orthopedic Surgeon
Position - Persian: متخصص ارتوپدي
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Sattarkhan Street, Tehran, Iran
Street address - Persian: تهران، خيابان ستارخان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6651 6001
Mobile: +98 912 684 3678
Fax:
Email: babak.otoukesh@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Rasool Hospital Name of organization / entity - Persian: بيمارستان رسول Full name of responsible person - English: Babak Otoukesh Full name of responsible person - Persian: بابك اتوكش Position - English: Orthopedic Surgeon Position - Persian: متخصص ارتوپدي Latest degree: specialist Area of specialty/work: 04 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Sattarkhan Street, Tehran, Iran Street address - Persian: تهران، خيابان ستارخان City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +216 651600198 21 6651 6001 Mobile: 00+98 912 684 3678 Fax: Email: babak_otoukeshbabak.otoukesh@yahoo.comgmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Rasool Hospital
Name of organization / entity - Persian: بيمارستان رسول اكرم
Full name of responsible person - English: Babak Otoukesh
Full name of responsible person - Persian: بابك اتوكش
Position - English: Orthopeics Surgeon
Position - Persian: متخصص ارتوپدي
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Sattarkhan Street, Tehran, Iran
Street address - Persian: تهران، خيابان ستارخان
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +216 6516001
Mobile: 00
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Iran university of medical sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Babak Otoukesh
Full name of responsible person - Persian: بابك اتوكش
Position - English: Orthopeics Surgeon
Position - Persian: متخصص ارتوپدي
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Sattarkhan Street, Tehran, Iran
Street address - Persian: تهران، خيابان ستارخان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 14456131
Phone: +216 6516001
Mobile: +98 912 684 3678
Fax:
Email: babak.otoukesh@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Rasool HospitalIran university of medical sciences Name of organization / entity - Persian: بيمارستان رسول اكرمدانشگاه علوم پزشکی ایران Full name of responsible person - English: Babak Otoukesh Full name of responsible person - Persian: بابك اتوكش Position - English: Orthopeics Surgeon Position - Persian: متخصص ارتوپدي Latest degree: specialist Area of specialty/work: 04 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Sattarkhan Street, Tehran, Iran Street address - Persian: تهران، خيابان ستارخان City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 14456131 Phone: +216 6516001 Mobile: 00+98 912 684 3678 Fax: Email: babak.otoukesh@gmail.com Web page address:
Sharing plan
yes
yes
yes
yes
na
na
yes
yes
yes
yes
na
na
na
na
empty
Just part of the original data, such as information related to the outcome or the possibility of sharing it
Just part of the original data, such as information related to the outcome or the possibility of sharing it
empty
فقط بخشی ازداده نظیر اطلاعات مربوط به پیامد اصلی یا امثال آن امکان اشتراک گذاری دارد.
فقط بخشی ازداده نظیر اطلاعات مربوط به پیامد اصلی یا امثال آن امکان اشتراک گذاری دارد.
empty
Access the course start 6 months after printing the results
Access the course start 6 months after printing the results
empty
شروع دوره دسترسی 6 ماه پس از چاپ نتایج
شروع دوره دسترسی 6 ماه پس از چاپ نتایج
empty
Just for researchers working in academic and scientific institutions will be available
Just for researchers working in academic and scientific institutions will be available
empty
فقط برای محققین شاغل در موسسات دانشگاهی و علمی در دسترس خواهد بود
فقط برای محققین شاغل در موسسات دانشگاهی و علمی در دسترس خواهد بود
empty
Only the fields of data use is possible
Only the fields of data use is possible
empty
تنها استفاده ی مطالعاتی از داده ها امکان پذیر است
تنها استفاده ی مطالعاتی از داده ها امکان پذیر است
empty
Dr. Babak otoukesh to the following phone and email address be referred
babak.otoukesh@gmail.com
+989126843678
Dr. Babak otoukesh to the following phone and email address be referred babak.otoukesh@gmail.com +989126843678
empty
به دکتر بابک اتوکش به آدرس ایمیل و تلفن ذیل مراجعه گردد
babak.otoukesh@gmail.com
+989126843678
به دکتر بابک اتوکش به آدرس ایمیل و تلفن ذیل مراجعه گردد babak.otoukesh@gmail.com +989126843678
empty
After reviewing the request will be answered within a maximum of 1 month
After reviewing the request will be answered within a maximum of 1 month
empty
درخواست پس از بررسی حداکثر ظرف یکماه پاسخ داده خواهد شد
درخواست پس از بررسی حداکثر ظرف یکماه پاسخ داده خواهد شد
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The result of this research paper has been published and accessible to the public via the link below :
https://www.termedia.pl/Evaluation-of-inflammatory-response-in-patients-undergoing-surgical-treatment-for-early-and-delayed-femoral-fractures,19,28559,1,1.html
The result of this research paper has been published and accessible to the public via the link below : https://www.termedia.pl/Evaluation-of-inflammatory-response-in-patients-undergoing-surgical-treatment-for-early-and-delayed-femoral-fractures,19,28559,1,1.html
empty
مقاله ی منتج از این پژوهش چاپ گردیده و قابل دسترسی برای همگان از طریق لینک زیر میباشد
https://www.termedia.pl/Evaluation-of-inflammatory-response-in-patients-undergoing-surgical-treatment-for-early-and-delayed-femoral-fractures,19,28559,1,1.html
مقاله ی منتج از این پژوهش چاپ گردیده و قابل دسترسی برای همگان از طریق لینک زیر میباشد https://www.termedia.pl/Evaluation-of-inflammatory-response-in-patients-undergoing-surgical-treatment-for-early-and-delayed-femoral-fractures,19,28559,1,1.html
Our findings suggest that serum levels of IL-8 were markedly decreased from 12 h until 48 h postoperatively (p < 0.05). Moreover, the results indicated that serum levels of TNF- were significantly increased in the early hours, but after 48 h a decreasing trend was detected (p < 0.05). Furthermore, serum levels of IL-10, IFN-, and IL-6 were significantly increased from 12 h until 48 h postoperatively (p < 0.05)
Our findings suggest that serum levels of IL-8 were markedly decreased from 12 h until 48 h postoperatively (p < 0.05). Moreover, the results indicated that serum levels of TNF- were significantly increased in the early hours, but after 48 h a decreasing trend was detected (p < 0.05). Furthermore, serum levels of IL-10, IFN-, and IL-6 were significantly increased from 12 h until 48 h postoperatively (p < 0.05)
Protocol summary
Study aim
The main purpose of this study is determination of alterations in serum level of inflammatory markers of interferon Gamma and interleukins 1, 5, and 6, and TNF-Alpha that would be measured at baseline and after one hour from surgery among patients with femoral fracture under early versus late surgery.
Design
Randomised, superiority, parallel group trial with blinded outcome assessment
Settings and conduct
Rasool Hospital , Sattarkhan Street
Participants/Inclusion and exclusion criteria
Inclusion criteria: Fracture of femoral shaft and aging from 20 to 50 years
Intervention groups
Patients with femoral fracture in the 2 groups were under the same surgery, before 24 hours of the visit to the hospital and after 24 hours of a visit to the hospital
Alterations in serum inflammatory markers in patients under early and late surgery for femoral fractures
Public title
Inflammation in femoral fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fracture of femoral shaft
no any other concomitant injury
aging from 20 to 50 years
Exclusion criteria:
Presence of concomitant injuries
presence of chronic inflammatory diseases
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
38
Actual sample size reached:
38
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
double blind , That is not the patient knew which group under the surgery and not see any sick doctor knew when and what time the surgery group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rasool Hospital
Street address
Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
93/912
Health conditions studied
1
Description of health condition studied
Fracture of shaft of femur
ICD-10 code
S72.3
ICD-10 code description
Fracture of shaft of femur
Primary outcomes
1
Description
Interferon Gamma
Timepoint
one hour after surgery
Method of measurement
Lab Kit
2
Description
Interleukin 1
Timepoint
one hour after surgery
Method of measurement
Lab Kit
3
Description
Interleukin 5
Timepoint
one hour after surgery
Method of measurement
Lab Kit
4
Description
Interleukin 6
Timepoint
one hour after surgery
Method of measurement
Lab Kit
5
Description
TNF-Alph
Timepoint
one hour after surgery
Method of measurement
Lab Kit
Secondary outcomes
1
Description
Interlukin 1
Timepoint
One hour after surgery
Method of measurement
Lab Kit
2
Description
IFN-Gamma
Timepoint
One hour after surgery
Method of measurement
lab kit
3
Description
TNF-Alpha
Timepoint
one hour after surgery
Method of measurement
lab kit
4
Description
interlukin 5
Timepoint
one hour after surgery
Method of measurement
lab kit
5
Description
interlukin 6
Timepoint
one hour after surgery
Method of measurement
lab kit
Intervention groups
1
Description
all patients with fractures of the femur bone that before 24 hours of admission to the emergency room, a common method of surgery are located and The fracture is fixed only by the plate
Category
Treatment - Surgery
2
Description
all patients with fractures of the femur bone that After 24 hours of admission to the emergency room, a common method of surgery are located and The fracture is fixed only by the plate
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Hospital
Full name of responsible person
Dr.Babak Otoukesh
Street address
sattarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 9595
Email
babak.otoukesh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Financial Department
Street address
Hemmat Exp Way, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Babak Otoukesh
Position
Orthopedics Surgeon
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Sattarkhan Street, Rasool Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+216 6516001
Fax
Email
babak.otoukesh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasool Hospital
Full name of responsible person
Babak Otoukesh
Position
Orthopedic Surgeon
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Sattarkhan Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 6001
Fax
Email
babak.otoukesh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Babak Otoukesh
Position
Orthopeics Surgeon
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Sattarkhan Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14456131
Phone
+216 6516001
Fax
Email
babak.otoukesh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
Just part of the original data, such as information related to the outcome or the possibility of sharing it
When the data will become available and for how long
Access the course start 6 months after printing the results
To whom data/document is available
Just for researchers working in academic and scientific institutions will be available
Under which criteria data/document could be used
Only the fields of data use is possible
From where data/document is obtainable
Dr. Babak otoukesh to the following phone and email address be referred
babak.otoukesh@gmail.com
+989126843678
What processes are involved for a request to access data/document
After reviewing the request will be answered within a maximum of 1 month
Comments
The result of this research paper has been published and accessible to the public via the link below :
https://www.termedia.pl/Evaluation-of-inflammatory-response-in-patients-undergoing-surgical-treatment-for-early-and-delayed-femoral-fractures,19,28559,1,1.html