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Protocol summary
Many complications during surgery may occur during hysterectomy, vaginal cuff complications such as bleeding, infection, organ prolapse and Disruption of the vaginal cuff, the side effects are rare but serious in hysterectomy. However, brief study to determine the exact cause and prevalence of vaginal cuff complication during laparoscopic hysterectomy has conducted. So we decided in this study to compare v lock and vicryle sutures for closure of the vaginal cuff and their association with bleeding during surgery, duration of surgery, incidence of vaginal cuff complications such as bleeding, infection, vaginal cuff dehiscence . This study will take place in the women's unit of Hazrat Rasoul Akram Hospital. 60 patient whom admitted for laparoscopic hysterectomy due to benign diseases in 95-96, according to the type of suture ,patients will be divided into two groups sutured v-lock = 30 and vicryle = 30 laparoscopic hysterectomy, will be done with laparoscopic team. Kind of energy will be used during laparoscopic hysterectomy is monopolar or bipolar or harmonic. In vicryle group suturing will be done continually. during surgery amount of bleeding, duration of surgery and timing of vaginal cuff closure will be written .all patients after transferring to unit from operative room will control for bleeding, and will follow up after discharge for 1 month (4 weeks) and 4 months (12 weeks) later post laparoscopy surgery. They have been called up for coming to clinic and will investigate the effects of vaginal cuff complications. Medical information’s of all patients on study due to inclusion criteria will be collected.
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Many complications during surgery may occur during hysterectomy, vaginal cuff complications such as bleeding, infection, organ prolapse and Disruption of the vaginal cuff, the side effects are rare but serious in hysterectomy. However, brief study to determine the exact cause and prevalence of vaginal cuff complication during laparoscopic hysterectomy has conducted. So we decided in this study to compare v lock and vicryle sutures for closure of the vaginal cuff and their association with bleeding during surgery, duration of surgery, incidence of vaginal cuff complications such as bleeding, infection, vaginal cuff dehiscence . This study will take place in the women's unit of Hazrat Rasoul Akram Hospital. 60 patient whom admitted for laparoscopic hysterectomy due to benign diseases in 95-96, according to the type of suture ,patients will be divided into two groups sutured v-lock = 30 and vicryle = 30 laparoscopic hysterectomy, will be done with laparoscopic team. Kind of energy will be used during laparoscopic hysterectomy is monopolar or bipolar or harmonic. In vicryle group suturing will be done continually. during surgery amount of bleeding, duration of surgery and timing of vaginal cuff closure will be written .all patients after transferring to unit from operative room will control for bleeding, and will follow up after discharge for 1 month (4 weeks) and 4 months (12 weeks) later post laparoscopy surgery. They have been called up for coming to clinic and will investigate the effects of vaginal cuff complications. Medical information’s of all patients on study due to inclusion criteria will be collected.
عوارض بسياري طي هيستركتومي در حين جراحي ممكن است رخ دهد،عوارض كاف واژن مانند خونريزي ،عفونت ،ازهم گسيختگي وبيرون زدگي احشا از كاف واژن،از عوارض نادر اما جدي هيستركتومي مي باشند.
با اين حال مطالعات مختصري جهت بررسي علت وشيوع دقيق عوارض كاف واژن طي هيستركتومي لاپاراسكوپيك،صورت گرفته است. لذا ما برآن شديم كه در اين طرح تحقيقاتي به بررسي مقايسه دونخ v lockو ويكريل حين بستن كاف واژن و ارتباط آن ها با خونريزي حين جراحي،زمان عمل جراحي وشيوع عوارض كاف واژن مانند خونريزي،عفونت،واز هم گسيختگي كاف واژن بپردازيم.
اين مطالعه در بخش زنان بيمارستان رسول اكرم صورت خواهد گرفت . 60بيماركه در سالهاي ٩٥،٩٦ جهت هيستركتومي لاپاراسكوپيك به دليل بيماريهاي خوش خيم زنان بستري ميشوند ،وارد مطالعه ما خواهند شد واين بيماران بر اساس نوع نخ به كار رفته جهت بستن كاف واژن،حين هيستركتومي لاپاراسكوپيك به دو گروه تقسيم خواهند شد.نخ ويكريل n =٣٠ ونخ vlock,n=٣٠
موارد هيستركتومي لاپاراسكوپيك توسط تيم لاپاراسكوپي انجام خواهد شد .نوع انرژي به كاررفته حين لاپاراسكوپيك هيستركتومي هارمونيك. يامونوپلار،خواهد بود.ودر گروه نخ ويكريل روش دوختن كاف به صورت مداوم انجام ميشود. حين جراحي ميزان خونريزي ومدت زمان جراحي ومدت زمان ترميم كاف واژن در دو گروه بررسي وثبت پرونده خواهد شد.وتمام بيماران پس از انتقال به بخش زنان از نظر خونريزي وپس از ترخيص جهت دو پيگيري روتين وانجام معاينه واژينال در فواصل زماني يكماه(٤هفته)وسه ماه(١٢هفته)پس از جراحي به درمانگاه لاپاراسكوپي فراخوانده ميشوند وبه لحاظ عوارض كاف واژن بررسي خواهند شد.اطلاعات پزشكي تمام بيماران براساس معيارهاي ورود جمع آوري وسپس بررسي خواهند شد.
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عوارض بسياري طي هيستركتومي در حين جراحي ممكن است رخ دهد،عوارض كاف واژن مانند خونريزي ،عفونت ،ازهم گسيختگي وبيرون زدگي احشا از كاف واژن،از عوارض نادر اما جدي هيستركتومي مي باشند. با اين حال مطالعات مختصري جهت بررسي علت وشيوع دقيق عوارض كاف واژن طي هيستركتومي لاپاراسكوپيك،صورت گرفته است. لذا ما برآن شديم كه در اين طرح تحقيقاتي به بررسي مقايسه دونخ v lockو ويكريل حين بستن كاف واژن و ارتباط آن ها با خونريزي حين جراحي،زمان عمل جراحي وشيوع عوارض كاف واژن مانند خونريزي،عفونت،واز هم گسيختگي كاف واژن بپردازيم. اين مطالعه در بخش زنان بيمارستان رسول اكرم صورت خواهد گرفت . 60بيماركه در سالهاي ٩٥،٩٦ جهت هيستركتومي لاپاراسكوپيك به دليل بيماريهاي خوش خيم زنان بستري ميشوند ،وارد مطالعه ما خواهند شد واين بيماران بر اساس نوع نخ به كار رفته جهت بستن كاف واژن،حين هيستركتومي لاپاراسكوپيك به دو گروه تقسيم خواهند شد.نخ ويكريل n =٣٠ ونخ vlock,n=٣٠ موارد هيستركتومي لاپاراسكوپيك توسط تيم لاپاراسكوپي انجام خواهد شد .نوع انرژي به كاررفته حين لاپاراسكوپيك هيستركتومي هارمونيك. يامونوپلار،خواهد بود.ودر گروه نخ ويكريل روش دوختن كاف به صورت مداوم انجام ميشود. حين جراحي ميزان خونريزي ومدت زمان جراحي ومدت زمان ترميم كاف واژن در دو گروه بررسي وثبت پرونده خواهد شد.وتمام بيماران پس از انتقال به بخش زنان از نظر خونريزي وپس از ترخيص جهت دو پيگيري روتين وانجام معاينه واژينال در فواصل زماني يكماه(٤هفته)وسه ماه(١٢هفته)پس از جراحي به درمانگاه لاپاراسكوپي فراخوانده ميشوند وبه لحاظ عوارض كاف واژن بررسي خواهند شد.اطلاعات پزشكي تمام بيماران براساس معيارهاي ورود جمع آوري وسپس بررسي خواهند شد.
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Comparing the effect of vicryle suture and v-lock suture using for vaginal cuff repair on incidence of post laparoscopic hysterectomy complications
Comparing the effect of vicryle suture and v-lock suture using for vaginal cuff repair on incidence of post laparoscopic hysterectomy complications
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تعیین و مقايسه تاثيرنخ ويكريل بانخ lock- vبراي ترميم كاف واژن در بروزعوارض پس از هيستركتومي لاپاراسكوپيك در زنان مراجعه كننده به بيمارستان رسول اكرم
تعیین و مقايسه تاثيرنخ ويكريل بانخ lock- vبراي ترميم كاف واژن در بروزعوارض پس از هيستركتومي لاپاراسكوپيك در زنان مراجعه كننده به بيمارستان رسول اكرم
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This research is a randomized clinical trial with a control group, parallel, double-blind, and 30-member groups in each group.
This research is a randomized clinical trial with a control group, parallel, double-blind, and 30-member groups in each group.
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این پژوهش یک کارآزمایی بالینی تصادفی، دارای گروه کنترل، با گروه های موازی ، دو سویه کور و با تعداد 30 نفر در هر گروه می باشد
این پژوهش یک کارآزمایی بالینی تصادفی، دارای گروه کنترل، با گروه های موازی ، دو سویه کور و با تعداد 30 نفر در هر گروه می باشد
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This study is carried out at Rasoul-e-Akram Hospital in Tehran. During surgery, the amount of bleeding and the time of surgery from the time of cutting the skin and entering the trowel until the end of surgery and sewing the skin, as well as the duration of vaginal cavity restoration in the two groups, will be investigated. All patients are referred to the laparoscopy clinic after transfer to the women's department for bleeding and after discharge for two routine follow-ups and vaginal examination at intervals of 1 and 3 months after surgery, and will be investigated for the complications of vaginal cuff.
This study is carried out at Rasoul-e-Akram Hospital in Tehran. During surgery, the amount of bleeding and the time of surgery from the time of cutting the skin and entering the trowel until the end of surgery and sewing the skin, as well as the duration of vaginal cavity restoration in the two groups, will be investigated. All patients are referred to the laparoscopy clinic after transfer to the women's department for bleeding and after discharge for two routine follow-ups and vaginal examination at intervals of 1 and 3 months after surgery, and will be investigated for the complications of vaginal cuff.
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این مطالعه در بیمارستان حضرت رسول اکرم (ص) شهر تهران انجام می شود. حين جراحي ميزان خونريزي ومدت زمان جراحي از زمان برش پوست و ورود تروكار تا زمان اتمام جراحي و دوختن پوست وهمچنين مدت زمان ترميم كاف واژن در دو گروه بررسي وثبت پرونده خواهد شد. تمام بيماران پس از انتقال به بخش زنان به لحاظ خونريزي وپس از ترخيص جهت دو پيگيري روتين و انجام معاينه واژينال در فواصل زماني يك وسه ماه پس از جراحي به درمانگاه لاپاراسكوپي فراخوانده ميشوند وبه لحاظ عوارض كاف واژن بررسي خواهند شد
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این مطالعه در بیمارستان حضرت رسول اکرم (ص) شهر تهران انجام می شود. حين جراحي ميزان خونريزي ومدت زمان جراحي از زمان برش پوست و ورود تروكار تا زمان اتمام جراحي و دوختن پوست وهمچنين مدت زمان ترميم كاف واژن در دو گروه بررسي وثبت پرونده خواهد شد. تمام بيماران پس از انتقال به بخش زنان به لحاظ خونريزي وپس از ترخيص جهت دو پيگيري روتين و انجام معاينه واژينال در فواصل زماني يك وسه ماه پس از جراحي به درمانگاه لاپاراسكوپي فراخوانده ميشوند وبه لحاظ عوارض كاف واژن بررسي خواهند شد .
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Inclusion criteria:
1) 65 years of age
2) hysterectomy due to benign uterine
3) the absence of prolapse of grade 3 and 4
4) the absence of a body mass index above 35,
5) lack of internal diseases
Exclusion criteria:
1) age over 65 years
2 ) pelvic prolapse grade 3 or 4
3) obesity (BMI) higher than 35
4) conditions that impair wound healing is: malnutration, anemia, DM, immuno compmised,smoking, steroids cansumation, rheumatologic disease, internal disease
Inclusion criteria: 1) 65 years of age 2) hysterectomy due to benign uterine 3) the absence of prolapse of grade 3 and 4 4) the absence of a body mass index above 35, 5) lack of internal diseases Exclusion criteria: 1) age over 65 years 2 ) pelvic prolapse grade 3 or 4 3) obesity (BMI) higher than 35 4) conditions that impair wound healing is: malnutration, anemia, DM, immuno compmised,smoking, steroids cansumation, rheumatologic disease, internal disease
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معیار ورود به مطالعه:
١)سن زير ٦٥سال
٢)هيستركتومي به دلايل خوش خيم رحمي
3) عدم وجود پرولاپس گرید 3 و4
4)عدم وجود نمایه توده بدنی بالای 35
5) عدم وجود بیماریهای داخلی
معيارهاي خروج:
١)سن بالاي ٦٥سال
٢)پرولاپس لگني گريد٣و٤
٣)چاقي(BMI)بالاتراز35
٤)شرايطي كه سبب اختلال ترميم زخم ميشود: -سوءتغذيه -آنمي -ديابت -نقص ايمني -مصرف سيگار -مصرف كورتون -بيماري هاي روماتولوژيك -وجود کلیه بیماریهای داخلی
معیار ورود به مطالعه: ١)سن زير ٦٥سال ٢)هيستركتومي به دلايل خوش خيم رحمي 3) عدم وجود پرولاپس گرید 3 و4 4)عدم وجود نمایه توده بدنی بالای 35 5) عدم وجود بیماریهای داخلی معيارهاي خروج: ١)سن بالاي ٦٥سال ٢)پرولاپس لگني گريد٣و٤ ٣)چاقي(BMI)بالاتراز35 ٤)شرايطي كه سبب اختلال ترميم زخم ميشود: -سوءتغذيه -آنمي -ديابت -نقص ايمني -مصرف سيگار -مصرف كورتون -بيماري هاي روماتولوژيك -وجود کلیه بیماریهای داخلی
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Intervention Group: suturing vaginal cuff during laparoscopic hysterectomy with v lock
Control Group: suturing vaginal cuff during laparoscopic hysterectomy with vicryle
Intervention Group: suturing vaginal cuff during laparoscopic hysterectomy with v lock Control Group: suturing vaginal cuff during laparoscopic hysterectomy with vicryle
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گروه مداخله: بستن كاف واژن،حين هيستركتومي لاپاراسكوپيك با نخ v lock
گروه کنترل: بستن كاف واژن،حين هيستركتومي لاپاراسكوپيك با نخ ويكريل
گروه مداخله: بستن كاف واژن،حين هيستركتومي لاپاراسكوپيك با نخ v lock گروه کنترل: بستن كاف واژن،حين هيستركتومي لاپاراسكوپيك با نخ ويكريل
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Complications caused by suturing vaginal cuff
Complications caused by suturing vaginal cuff
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عوارض ناشی از بستن کاف واژن
عوارض ناشی از بستن کاف واژن
General information
Single blinded
Double blinded
singldoubl
1
1
1
1
65 years of age
hysterectomy due to benign uterine
the absence of prolapse of grade 3 and 4
the absence of a body mass index above 35
lack of internal diseases
65 years of age hysterectomy due to benign uterine the absence of prolapse of grade 3 and 4 the absence of a body mass index above 35 lack of internal diseases
سن زير ٦٥سال
هيستركتومي به دلايل خوش خيم رحمي
عدم وجود پرولاپس گرید 3 و4
عدم وجود نمایه توده بدنی بالای 35
عدم وجود بیماریهای داخلی
سن زير ٦٥سال هيستركتومي به دلايل خوش خيم رحمي عدم وجود پرولاپس گرید 3 و4 عدم وجود نمایه توده بدنی بالای 35 عدم وجود بیماریهای داخلی
age over 65 years
pelvic prolapse grade 3 or 4
obesity (BMI) higher than 35
conditions that impair wound healing is: malnutration, anemia, DM, immuno compmised,smoking, steroids cansumation, rheumatologic disease, internal disease
age over 65 years pelvic prolapse grade 3 or 4 obesity (BMI) higher than 35 conditions that impair wound healing is: malnutration, anemia, DM, immuno compmised,smoking, steroids cansumation, rheumatologic disease, internal disease
Randomization was performed using the "= RANDBETWEEN(1,60)" function in excel software. So that the patients are assigned to two intervention and control groups before the surgery, after the informed consent.
Randomization was performed using the "= RANDBETWEEN(1,60)" function in excel software. So that the patients are assigned to two intervention and control groups before the surgery, after the informed consent.
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تصادفی سازی با استفاده از تابع "RANDBETWEEN(1,60)=" در نرم افزار اکسل بوده ، بگونه ای که بیماران پس از رضایت آگاهانه قبل از جراحی به دو گروه مداخله و گروه کنترل تخصیص می یابند
تصادفی سازی با استفاده از تابع "RANDBETWEEN(1,60)=" در نرم افزار اکسل بوده ، بگونه ای که بیماران پس از رضایت آگاهانه قبل از جراحی به دو گروه مداخله و گروه کنترل تخصیص می یابند
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The study is done in double blind, so that subjects and outcome evaluator do not know the allocation of the two groups.
The study is done in double blind, so that subjects and outcome evaluator do not know the allocation of the two groups.
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مطالعه بصورت دو سوکور انجام می شود بصورتی که آزمودنی ها و بررسی کننده پیامد از تخصیص دو گروه اطلاعی نخواهند داشت.
مطالعه بصورت دو سوکور انجام می شود بصورتی که آزمودنی ها و بررسی کننده پیامد از تخصیص دو گروه اطلاعی نخواهند داشت.
Recruitment centers
#1
Name of recruitment center - English: Rasoul-e-akram hospital- womens unit
Name of recruitment center - Persian: بخش زنان بیمارستان رسول اکرم
Full name of responsible person - English: Abolfazal Mehdizadeh kashi
Full name of responsible person - Persian: دکتر ابوالفضل مهدیزاده
Street address - English: Niayesh Av. Sattar khan st. Tehran, Iran
Street address - Persian: بیمارستان رسول اکرم - بخش زنان و زایمان - مرکز تحقیقات اندومتریوز
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: Rasoul-e-akram hospital- womens unit
Name of recruitment center - Persian: بخش زنان بیمارستان رسول اکرم
Full name of responsible person - English: Abolfazal Mehdizadeh kashi
Full name of responsible person - Persian: دکتر ابوالفضل مهدیزاده
Street address - English: Niayesh Av. Sattar khan st. Tehran, Iran
Street address - Persian: بیمارستان رسول اکرم - بخش زنان و زایمان - مرکز تحقیقات اندومتریوز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6650 9283
Fax:
Email: amehdizadehkashi@yahoo.com
Web page address:
Name of recruitment center - English: Rasoul-e-akram hospital- womens unit Name of recruitment center - Persian: بخش زنان بیمارستان رسول اکرم Full name of responsible person - English: Abolfazal Mehdizadeh kashi Full name of responsible person - Persian: دکتر ابوالفضل مهدیزاده Street address - English: Niayesh Av. Sattar khan st. Tehran, Iran Street address - Persian: بیمارستان رسول اکرم - بخش زنان و زایمان - مرکز تحقیقات اندومتریوز City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6650 9283 Fax: Email: amehdizadehkashi@yahoo.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 پزشکی ایران
Full name of responsible person - English: Dr.mehdizadeh
Full name of responsible person - Persian: دکتر مهدی زاده
Street address - English: rasoul akram hospital- obstetric gynecology unit
Street address - Persian: بیمارستان رسول اکرم- بخش زنان و زایمان
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 پزشکی ایران
Full name of responsible person - English: kazem malakouti
Full name of responsible person - Persian: کاظم ملکوتی
Street address - English: Hemat Highway next to Milad Tower, Iran University of Medical Sciences
Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 86701
Fax:
Email: adminsite@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 پزشکی ایران Full name of responsible person - English: Dr.mehdizadehkazem malakouti Full name of responsible person - Persian: دکتر مهدی زادهکاظم ملکوتی Street address - English: rasoul akram hospital- obstetric gynecology unitHemat Highway next to Milad Tower, Iran University of Medical Sciences Street address - Persian: بیمارستان رسول اکرم- بخش زنان و زایمانبزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 21 86701 Fax: Email: adminsite@iums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Dr. mania kaveh
Full name of responsible person - Persian: مانیا کاوه
Position - English: Resident of Obstetrics and Gynecology
Position - Persian: دستیار فلوشیپ لاپاراسکوپی زنان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Niayesh Av. Sattar khan St. Tehran, Iran
Street address - Persian: خیابان ستار خان- خیابان نیایش- بیمارستان رسول اکرم
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6650 9283
Mobile: +91 23774054
Fax: +98 66509283
Email: maniakaveh@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Dr. mania kaveh
Full name of responsible person - Persian: مانیا کاوه
Position - English: Resident of Obstetrics and Gynecology
Position - Persian: دستیار فلوشیپ لاپاراسکوپی زنان
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Niayesh Av. Sattar khan St. Tehran, Iran
Street address - Persian: خیابان ستار خان- خیابان نیایش- بیمارستان رسول اکرم
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 6650 9283
Mobile: +98 912 377 4054
Fax:
Email: maniakaveh@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Iran University of Medical Science Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران Full name of responsible person - English: Dr. mania kaveh Full name of responsible person - Persian: مانیا کاوه Position - English: Resident of Obstetrics and Gynecology Position - Persian: دستیار فلوشیپ لاپاراسکوپی زنان Latest degree: sub_specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Niayesh Av. Sattar khan St. Tehran, Iran Street address - Persian: خیابان ستار خان- خیابان نیایش- بیمارستان رسول اکرم 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 6650 9283 Mobile: +91 2377405498 912 377 4054 Fax: +98 66509283 Email: maniakaveh@gmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Dr. shahla chaichian
Full name of responsible person - Persian: شهلا چاییچیان
Position - English: Professor of Obstetrics and Gynecology
Position - Persian: متخصص زنان - فلوشیپ لاپاراسکوپی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Niayesh Av. Sattar khan st. Tehran, Iran.
Street address - Persian: ستارخان- نیایش - بیمارستان رسول اکرم
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6650 9283
Mobile: +91 21303526
Fax: +98 66509283
Email: shahlachaichian@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Dr. shahla chaichian
Full name of responsible person - Persian: شهلا چاییچیان
Position - English: Professor of Obstetrics and Gynecology
Position - Persian: متخصص زنان - فلوشیپ لاپاراسکوپی
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Niayesh Av. Sattar khan st. Tehran, Iran.
Street address - Persian: ستارخان- نیایش - بیمارستان رسول اکرم
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 6650 9283
Mobile: +98 912 130 3526
Fax:
Email: shahlachaichian@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Iran University of Medical Science Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران Full name of responsible person - English: Dr. shahla chaichian Full name of responsible person - Persian: شهلا چاییچیان Position - English: Professor of Obstetrics and Gynecology Position - Persian: متخصص زنان - فلوشیپ لاپاراسکوپی Latest degree: sub_specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Niayesh Av. Sattar khan st. Tehran, Iran. Street address - Persian: ستارخان- نیایش - بیمارستان رسول اکرم 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 6650 9283 Mobile: +91 2130352698 912 130 3526 Fax: +98 66509283 Email: shahlachaichian@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Dr.mania kaveh
Full name of responsible person - Persian: مانیا کاوه
Position - English: MD, Assistant professor of Obstetrics and Gynecology
Position - Persian: دستیار فلوشیپ زنان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Niayesh Av. Sattar khan st. Tehran, Iran.
Street address - Persian: ستار خان- خیابان نیایش - بیمارستان رسول اکرم
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6650 9283
Mobile: +98 912 377 4054
Fax: +98 66509283
Email: maniakaveh@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Iran University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Dr. mania kaveh
Full name of responsible person - Persian: مانیا کاوه
Position - English: Resident of Obstetrics and Gynecology
Position - Persian: دستیار فلوشیپ لاپاراسکوپی زنان
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Niayesh Av. Sattar khan St. Tehran, Iran
Street address - Persian: خیابان ستار خان- خیابان نیایش- بیمارستان رسول اکرم
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 6650 9283
Mobile: +98 91223774054
Fax: +98 21 6650 9283
Email: maniakaveh@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Iran University of Medical Science Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران Full name of responsible person - English: Dr.maniaDr. mania kaveh Full name of responsible person - Persian: مانیا کاوه Position - English: MD, Assistant professorResident of Obstetrics and Gynecology Position - Persian: دستیار فلوشیپ لاپاراسکوپی زنان Latest degree: sub_specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Niayesh Av. Sattar khan stSt. Tehran, Iran. Street address - Persian: خیابان ستار خان- خیابان نیایش- بیمارستان رسول اکرم 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 6650 9283 Mobile: +98 912 377 405491223774054 Fax: +98 6650928321 6650 9283 Email: maniakaveh@gmail.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
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No more information
No more information
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اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Protocol summary
Study aim
Comparing the effect of vicryle suture and v-lock suture using for vaginal cuff repair on incidence of post laparoscopic hysterectomy complications
Design
This research is a randomized clinical trial with a control group, parallel, double-blind, and 30-member groups in each group.
Settings and conduct
This study is carried out at Rasoul-e-Akram Hospital in Tehran. During surgery, the amount of bleeding and the time of surgery from the time of cutting the skin and entering the trowel until the end of surgery and sewing the skin, as well as the duration of vaginal cavity restoration in the two groups, will be investigated. All patients are referred to the laparoscopy clinic after transfer to the women's department for bleeding and after discharge for two routine follow-ups and vaginal examination at intervals of 1 and 3 months after surgery, and will be investigated for the complications of vaginal cuff.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) 65 years of age
2) hysterectomy due to benign uterine
3) the absence of prolapse of grade 3 and 4
4) the absence of a body mass index above 35,
5) lack of internal diseases
Exclusion criteria:
1) age over 65 years
2 ) pelvic prolapse grade 3 or 4
3) obesity (BMI) higher than 35
4) conditions that impair wound healing is: malnutration, anemia, DM, immuno compmised,smoking, steroids cansumation, rheumatologic disease, internal disease
Intervention groups
Intervention Group: suturing vaginal cuff during laparoscopic hysterectomy with v lock
Control Group: suturing vaginal cuff during laparoscopic hysterectomy with vicryle
Main outcome variables
Complications caused by suturing vaginal cuff
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017013123666N5
Registration date:2017-02-28, 1395/12/10
Registration timing:registered_while_recruiting
Last update:2018-06-02, 1397/03/12
Update count:1
Registration date
2017-02-28, 1395/12/10
Registrant information
Name
Abolfazl Mehdizadeh kashi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 216651500
Email address
mehdizadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran university of medical scince
Expected recruitment start date
2017-01-24, 1395/11/05
Expected recruitment end date
2018-01-25, 1396/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of vicryle suture and v-lock suture using for vaginal cuff repair on incidence of post laparoscopic hysterectomy complications.
Public title
Comparison the effect of vicryle suture and v-lock suture for repairing vaginal cuff
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
65 years of age
hysterectomy due to benign uterine
the absence of prolapse of grade 3 and 4
the absence of a body mass index above 35
lack of internal diseases
Exclusion criteria:
age over 65 years
pelvic prolapse grade 3 or 4
obesity (BMI) higher than 35
conditions that impair wound healing is: malnutration, anemia, DM, immuno compmised,smoking, steroids cansumation, rheumatologic disease, internal disease
Age
From 17 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed using the "= RANDBETWEEN(1,60)" function in excel software. So that the patients are assigned to two intervention and control groups before the surgery, after the informed consent.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is done in double blind, so that subjects and outcome evaluator do not know the allocation of the two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Science
Street address
Iran . Tehran . Hemat Highway . Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.IUMS.REC 1395.95-03-218-29659
Health conditions studied
1
Description of health condition studied
complication of vaginal cuff
ICD-10 code
N99.9
ICD-10 code description
Other disorders of the genitourinary system
Primary outcomes
1
Description
vaginal bleeding
Timepoint
3 months after surgery
Method of measurement
visit and reports
2
Description
infection of vaginal cuff
Timepoint
3 months after surgery
Method of measurement
visit and reports
3
Description
Dehiscence of vaginal cuff
Timepoint
3 months after surgery
Method of measurement
visit and reports
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: in this group suturing vaginal cuff during laparoscopic hysterectomy will done with v lock
Category
Treatment - Surgery
2
Description
Control Group: In this group suturing vaginal cuff during laparoscopic hysterectomy will done with vicryle
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-akram hospital- womens unit
Full name of responsible person
Abolfazal Mehdizadeh kashi
Street address
Niayesh Av. Sattar khan st. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Email
amehdizadehkashi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
kazem malakouti
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@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 Science
Full name of responsible person
Dr. mania kaveh
Position
Resident of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Niayesh Av. Sattar khan St. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
Email
maniakaveh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. shahla chaichian
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Niayesh Av. Sattar khan st. Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
Email
shahlachaichian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. mania kaveh
Position
Resident of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Niayesh Av. Sattar khan St. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
+98 21 6650 9283
Email
maniakaveh@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available