Comparison of outcomes and complications between anterior repair and resection-anastomosis of small intestine for closure of loop ileostomy performed in patients underwent rectal cancer resetion surgery
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Protocol summary
Loop ileostomy is a major surgical procedure suggested to control the complications of colorectal anastomosis, especially disruption and anastomosis leakage in patients undergoing resection of the distal rectum cancers. This trial is done to compare two methods of anterior repair and resection and anastomosis of the small intestine for ileostomy closure. For a better and more accurate comparison, we decided to perform the clinical trial in two randomized groups of 20 patients to answer the research questions.
Goals: To compare complications after surgery in two groups of anterior repair and resection and anastomosis. These complications include early complications such as anastomosis leakage, infection, bleeding, in addition to late complications such as anastomosis stricture and obstruction.
Method and participants: This study is a randomized clinical trial in two groups of 20 patients who underwent LAR surgery for rectal cancer and protective loop ileostomy.
Intervention: Patients in two groups were randomly assigned. The first group underwent intestinal resection in the distal and proximal part of ileostomy and then an hand-sewn anastomosis was done. In the second group the anterior defect within the ileostomy was repaired.
Main outcomes : first day of defecation / first day of flatus / first day of oral feeding / post operation early complications / post operation late complications
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Loop ileostomy is a major surgical procedure suggested to control the complications of colorectal anastomosis, especially disruption and anastomosis leakage in patients undergoing resection of the distal rectum cancers. This trial is done to compare two methods of anterior repair and resection and anastomosis of the small intestine for ileostomy closure. For a better and more accurate comparison, we decided to perform the clinical trial in two randomized groups of 20 patients to answer the research questions. Goals: To compare complications after surgery in two groups of anterior repair and resection and anastomosis. These complications include early complications such as anastomosis leakage, infection, bleeding, in addition to late complications such as anastomosis stricture and obstruction. Method and participants: This study is a randomized clinical trial in two groups of 20 patients who underwent LAR surgery for rectal cancer and protective loop ileostomy. Intervention: Patients in two groups were randomly assigned. The first group underwent intestinal resection in the distal and proximal part of ileostomy and then an hand-sewn anastomosis was done. In the second group the anterior defect within the ileostomy was repaired. Main outcomes : first day of defecation / first day of flatus / first day of oral feeding / post operation early complications / post operation late complications
لوپ ایلئوستومی به عنوان یک اقدام جراحی مهم و پیشنهاد شده به منظور کنترل هر چه بهتر عوارض ناشی از آناستوموز روده بزرگ به خصوص باز شدن و لیک آناستوموز در بیمارانی که تحت جراحی رزکسیون کانسرهای دیستال رکتوم قرار میگیرند استفاده می شود. به منظور انجام هر چه بهتر و دقیقتر این مقایسه بر آن شدیم تا مطالعه ای به صورت کارآزمایی بالینی در دو گروه 20 بیماره به صورت تصادفی طراحی کنیم تا به بهترین نحو بتوانیم به این سوال پژوهشی پاسخ دهیم. اهداف:بررسی عوارض بعد از عمل جراحی دو گروه ترمیم قدامی و رزکسیون و آناستوموز و مقایسه ی آنها.که این عوارض شامل عوارض زودرس شامل لیک آناستوموز عفونت و خونریزی و عوارض دیررس شامل تنگی آناستوموز و انسداد روده می باشد.
طراحی و شرکت کنندگان:این مطالعه به صورت کار آزمایی بالینی و به صورت تصادفی در دو گروه 20 نفره از بیماران که تحت عمل جراحی LAR در زمینه ی کانسر رکتوم قرار گرفته و ایلئوستومی لوپ محافظتی دارند انجام می شود.
نحوه ی انجام و مداخلات:بیماران بعد از تصادفی شدن در دو گروه در گروه اول تحت رزکسیون روده در سمت دیستال و پروگزیمال محل ایلئوستومی قرار گرفته و سپس روده تحت آتاستوموز با دست قرار می گیرد.در گروه دوم محل نقص قدامی روده در محل ایلئوستومی ترمیم می شود.
متغیرهای پیامد اصلی:شامل روز اولین دفع مدفوع / روز اولین دفع گاز / روز شروع تغذیه خوراکی / عوارض زودرس بعد از عمل / عوارض دیررس بعد از عمل می باشند.
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لوپ ایلئوستومی به عنوان یک اقدام جراحی مهم و پیشنهاد شده به منظور کنترل هر چه بهتر عوارض ناشی از آناستوموز روده بزرگ به خصوص باز شدن و لیک آناستوموز در بیمارانی که تحت جراحی رزکسیون کانسرهای دیستال رکتوم قرار میگیرند استفاده می شود. به منظور انجام هر چه بهتر و دقیقتر این مقایسه بر آن شدیم تا مطالعه ای به صورت کارآزمایی بالینی در دو گروه 20 بیماره به صورت تصادفی طراحی کنیم تا به بهترین نحو بتوانیم به این سوال پژوهشی پاسخ دهیم. اهداف:بررسی عوارض بعد از عمل جراحی دو گروه ترمیم قدامی و رزکسیون و آناستوموز و مقایسه ی آنها.که این عوارض شامل عوارض زودرس شامل لیک آناستوموز عفونت و خونریزی و عوارض دیررس شامل تنگی آناستوموز و انسداد روده می باشد. طراحی و شرکت کنندگان:این مطالعه به صورت کار آزمایی بالینی و به صورت تصادفی در دو گروه 20 نفره از بیماران که تحت عمل جراحی LAR در زمینه ی کانسر رکتوم قرار گرفته و ایلئوستومی لوپ محافظتی دارند انجام می شود. نحوه ی انجام و مداخلات:بیماران بعد از تصادفی شدن در دو گروه در گروه اول تحت رزکسیون روده در سمت دیستال و پروگزیمال محل ایلئوستومی قرار گرفته و سپس روده تحت آتاستوموز با دست قرار می گیرد.در گروه دوم محل نقص قدامی روده در محل ایلئوستومی ترمیم می شود. متغیرهای پیامد اصلی:شامل روز اولین دفع مدفوع / روز اولین دفع گاز / روز شروع تغذیه خوراکی / عوارض زودرس بعد از عمل / عوارض دیررس بعد از عمل می باشند.
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To compare complications after surgery in two groups of anterior repair versus resection and hand_sewn anastomosis.
To compare complications after surgery in two groups of anterior repair versus resection and hand_sewn anastomosis.
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بررسی عوارض بعد از عمل جراحی دو گروه ترمیم قدامی و رزکسیون و آناستوموز با دست و مقایسه ی آنها.
بررسی عوارض بعد از عمل جراحی دو گروه ترمیم قدامی و رزکسیون و آناستوموز با دست و مقایسه ی آنها.
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This is a prospective, randomized, double-blind clinical trial.
This is a prospective, randomized, double-blind clinical trial.
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این یک کارآزمایی بالینی آینده نگر، تصادفی، دوسوکور است.
این یک کارآزمایی بالینی آینده نگر، تصادفی، دوسوکور است.
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This study was performed at the colorectal surgery division of department of surgery at Tehran University of Medical Sciences between September 1, 2016 and December 1, 2018.
This study was performed at the colorectal surgery division of department of surgery at Tehran University of Medical Sciences between September 1, 2016 and December 1, 2018.
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این مطالعه در بخش جراحی کولورکتال گروه جراحی دانشگاه علوم پزشکی تهران در فاصله زمانی 10 شهریور 1395 تا 10 آذر 1397 انجام شد.
این مطالعه در بخش جراحی کولورکتال گروه جراحی دانشگاه علوم پزشکی تهران در فاصله زمانی 10 شهریور 1395 تا 10 آذر 1397 انجام شد.
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Inclusion criterion: patients with history of rectal cancer underwent low anterior resection surgery with protective loop ileostomy.
Exclusion criteria: immune deficiency; rectal anastomosis complications; history of abdominal surgery except rectal surgery.
Inclusion criterion: patients with history of rectal cancer underwent low anterior resection surgery with protective loop ileostomy. Exclusion criteria: immune deficiency; rectal anastomosis complications; history of abdominal surgery except rectal surgery.
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معیارهای ورود:
1) بیماران با سابقه ی عمل جراحی در زمینه ی کانسر رکتوم به روش LAR و دارای ایلئوستومی پروتکتیو لوپ
معیارهای خروج:
1) بیمارانی با نقص ایمنی
2) مشکلات مرتبط با آناستوموز رکتوم
3) سابقه جراحی های شکمی به جز عمل مرتبط با کانسر رکتوم
معیارهای ورود: 1) بیماران با سابقه ی عمل جراحی در زمینه ی کانسر رکتوم به روش LAR و دارای ایلئوستومی پروتکتیو لوپ معیارهای خروج: 1) بیمارانی با نقص ایمنی 2) مشکلات مرتبط با آناستوموز رکتوم 3) سابقه جراحی های شکمی به جز عمل مرتبط با کانسر رکتوم
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Intervention group A: 20 patients randomly selected and placed in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site were resected then anastomosed. Intervention group B : 20 patients randomly selected and placed in the anterior repair group. Anterior intestinal defect within the ileostomy site was repaired.
Intervention group A: 20 patients randomly selected and placed in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site were resected then anastomosed. Intervention group B : 20 patients randomly selected and placed in the anterior repair group. Anterior intestinal defect within the ileostomy site was repaired.
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گروه مداخله ای اول=20 بیمار به صورت تصادفی انتخاب و در گروه رزکسیون و آناستوموز قرار می گیرند. پروگزیمال و دیستال روده در محل ایلئوستومی رزکت شده و روده تحت آناستوموز قرار می گیرد.
گروه مداخله ای دوم=20 بیمار به صورت تصادفی انتخاب و در گروه ترمیم قدامی قرار می گیرند. نقص قدامی روده در محل ایلئوستومی تحت ترمیم قدامی قرار می گیرد.
گروه مداخله ای اول=20 بیمار به صورت تصادفی انتخاب و در گروه رزکسیون و آناستوموز قرار می گیرند. پروگزیمال و دیستال روده در محل ایلئوستومی رزکت شده و روده تحت آناستوموز قرار می گیرد. گروه مداخله ای دوم=20 بیمار به صورت تصادفی انتخاب و در گروه ترمیم قدامی قرار می گیرند. نقص قدامی روده در محل ایلئوستومی تحت ترمیم قدامی قرار می گیرد.
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the first day of defecation / the first day of flatus / the first day of oral feeding / post operation early complications / post operation late complications
the first day of defecation / the first day of flatus / the first day of oral feeding / post operation early complications / post operation late complications
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روز اولین دفع مدفوع \ روز اولین دفع گاز \ روز شروع تغذیه خوراکی \ عوارض زودرس بعد از عمل \ عوارض دیررس بعد از عمل
روز اولین دفع مدفوع \ روز اولین دفع گاز \ روز شروع تغذیه خوراکی \ عوارض زودرس بعد از عمل \ عوارض دیررس بعد از عمل
General information
Single blinded
Double blinded
singldoubl
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1
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In this study, participants, collectors of results and analyzers, were blind to the study. Wrongly، single-blind study was entered that should be corrected to double-blind study.
In this study, participants, collectors of results and analyzers, were blind to the study. Wrongly، single-blind study was entered that should be corrected to double-blind study.
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در این مطالعه، شرکت کنندگان، جمع اوری کنندگان نتایج و انالیزور، نسبت به مطالعه کور بودند. به اشتباه، مطالعه یک سویه کور وارد شده بود که باید به دو سویه کور اصلاح گردد.
در این مطالعه، شرکت کنندگان، جمع اوری کنندگان نتایج و انالیزور، نسبت به مطالعه کور بودند. به اشتباه، مطالعه یک سویه کور وارد شده بود که باید به دو سویه کور اصلاح گردد.
Patients with a history of rectal cancer who had undergone curative low anterior resection for rectal cancer and a diverting protective loop ileostomy
Patients with a history of rectal cancer who had undergone curative low anterior resection for rectal cancer and a diverting protective loop ileostomy
بیماران با سابقه کانسر رکتوم که تحت جراحی LAR و تعبیه ایلیوستومی لوپ پروتکتیو قرار گرفتند.
بیماران با سابقه کانسر رکتوم که تحت جراحی LAR و تعبیه ایلیوستومی لوپ پروتکتیو قرار گرفتند.
history of immunodeficiency
complications associated with rectal anastomosis, including anastomotic leakage, para-anastomotic sinuses
previous abdominal operation other than rectal cancer surgery
history of immunodeficiency complications associated with rectal anastomosis, including anastomotic leakage, para-anastomotic sinuses previous abdominal operation other than rectal cancer surgery
سابقه نقص ایمنی
عوارض مربوط به اناستوموز رکتال
سابقه قبلی جراحی شکمی به جز جراحی کانسر رکتوم
سابقه نقص ایمنی عوارض مربوط به اناستوموز رکتال سابقه قبلی جراحی شکمی به جز جراحی کانسر رکتوم
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patients were randomly assigned into two groups using randomly permuted blocks method. random allocation sequence was generated by the online platform www.randomization.com.
patients were randomly assigned into two groups using randomly permuted blocks method. random allocation sequence was generated by the online platform www.randomization.com.
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بیماران با استفاده از روش بلوک های جایگزین شده تصادفی به دو گروه تقسیم شدند. توالی تخصیص تصادفی توسط پلت فرم آنلاین www.randomization.com ایجاد شد.
بیماران با استفاده از روش بلوک های جایگزین شده تصادفی به دو گروه تقسیم شدند. توالی تخصیص تصادفی توسط پلت فرم آنلاین www.randomization.com ایجاد شد.
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In this double-blind study, participants, collectors of results and analyzers, were blind to the study.
In this double-blind study, participants, collectors of results and analyzers, were blind to the study.
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در این مطالعه دو سویه کور، شرکت کنندگان، جمع اوری کنندگان نتایج و انالیزور، نسبت به مطالعه کور بودند.
در این مطالعه دو سویه کور، شرکت کنندگان، جمع اوری کنندگان نتایج و انالیزور، نسبت به مطالعه کور بودند.
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Recruitment centers
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Name of recruitment center - English: Tehran University of Medical Sciences, Imam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی(ره) - دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr. Mohammad Reza Keramati
Full name of responsible person - Persian: دکتر محمدرضا کرامتی
Street address - English: Imam Khomeini Hospital, Keshavarz blvd.
Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره)
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: Tehran University of Medical Sciences, Imam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی(ره) - دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr. Mohammad Reza Keramati
Full name of responsible person - Persian: دکتر محمدرضا کرامتی
Street address - English: Imam Khomeini Hospital, Keshavarz blvd.
Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 123454567890
Phone: +98 21 6119 0000
Fax:
Email: mr-keramati@tums.ac.ir
Web page address:
Name of recruitment center - English: Tehran University of Medical Sciences, Imam Khomeini Hospital Name of recruitment center - Persian: بیمارستان امام خمینی(ره) - دانشگاه علوم پزشکی تهران Full name of responsible person - English: Dr. Mohammad Reza Keramati Full name of responsible person - Persian: دکتر محمدرضا کرامتی Street address - English: Imam Khomeini Hospital, Keshavarz blvd. Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 123454567890 Phone: +98 21 6119 0000 Fax: Email: mr-keramati@tums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Researach deputy, School of Medicine, Tehran University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران - دانشکده پزشکی
Full name of responsible person - English: Dr. Shahin Akhoondzadeh
Full name of responsible person - Persian: دکتر شاهین آخوندزاده
Street address - English: Faculty of Medicine, Poor-sina St., Keshavarz Blvd.
Street address - Persian: بلوار کشاورز - خ 16 آذر - خ پورسینا - دانشکده پزشکی
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: Researach deputy, School of Medicine, Tehran University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران - دانشکده پزشکی
Full name of responsible person - English: Dr. Shahin Akhoondzadeh
Full name of responsible person - Persian: دکتر شاهین آخوندزاده
Street address - English: Faculty of Medicine, Poor-sina St., Keshavarz Blvd.
Street address - Persian: بلوار کشاورز - خ 16 آذر - خ پورسینا - دانشکده پزشکی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1234567890
Phone: +98 21 6119 0000
Fax:
Email: mr-keramati@tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Researach deputy, School of Medicine, Tehran University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران - دانشکده پزشکی Full name of responsible person - English: Dr. Shahin Akhoondzadeh Full name of responsible person - Persian: دکتر شاهین آخوندزاده Street address - English: Faculty of Medicine, Poor-sina St., Keshavarz Blvd. Street address - Persian: بلوار کشاورز - خ 16 آذر - خ پورسینا - دانشکده پزشکی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1234567890 Phone: +98 21 6119 0000 Fax: Email: mr-keramati@tums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr. Seyed Mostafa Meshkati Yazd
Full name of responsible person - Persian: دکتر سید مصطفی مشکاتی یزد
Position - English: MD/ Resident of surgery
Position - Persian: رزیدنت جراحی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Keshavarz blvd.
Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 8860 7395
Mobile: +98 912 205 7377
Fax:
Email: mostafa.meshkati@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr. Seyed Mostafa Meshkati Yazd
Full name of responsible person - Persian: دکتر سید مصطفی مشکاتی یزد
Position - English: MD/ Resident of surgery
Position - Persian: رزیدنت جراحی
Latest degree: med_doctor
Area of specialty/work: 36
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Keshavarz blvd.
Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 123456789
Phone: +98 21 8860 7395
Mobile: +98 912 205 7377
Fax:
Email: mostafa.meshkati@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران Full name of responsible person - English: Dr. Seyed Mostafa Meshkati Yazd Full name of responsible person - Persian: دکتر سید مصطفی مشکاتی یزد Position - English: MD/ Resident of surgery Position - Persian: رزیدنت جراحی Latest degree: med_doctor Area of specialty/work: 036 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Imam Khomeini hospital, Keshavarz blvd. Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره) City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 123456789 Phone: +98 21 8860 7395 Mobile: +98 912 205 7377 Fax: Email: mostafa.meshkati@gmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr. Mohammad Reza Keramati
Full name of responsible person - Persian: دکتر محمدرضا کرامتی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Keshavarz blvd.
Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 2283 3381
Mobile: +98 912 114 7406
Fax:
Email: mr-keramati@razi.tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr. Mohammad Reza Keramati
Full name of responsible person - Persian: دکتر محمدرضا کرامتی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 36
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Keshavarz blvd.
Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1234567890
Phone: +98 21 2283 3381
Mobile: +98 912 114 7406
Fax:
Email: mr-keramati@razi.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران Full name of responsible person - English: Dr. Mohammad Reza Keramati Full name of responsible person - Persian: دکتر محمدرضا کرامتی Position - English: Assistant Professor Position - Persian: استادیار Latest degree: specialist Area of specialty/work: 036 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Imam Khomeini hospital, Keshavarz blvd. Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره) City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1234567890 Phone: +98 21 2283 3381 Mobile: +98 912 114 7406 Fax: Email: mr-keramati@razi.tums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr. Mohammad Reza Keramati
Full name of responsible person - Persian: دکتر محمدرضا کرامتی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Keshavarz blvd.
Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 2283 3381
Mobile: +98 912 114 7406
Fax:
Email: mr-keramati@razi.tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr. Mohammad Reza Keramati
Full name of responsible person - Persian: دکتر محمدرضا کرامتی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 36
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Khomeini hospital, Keshavarz blvd.
Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1234567890
Phone: +98 21 2283 3381
Mobile: +98 912 114 7406
Fax:
Email: mr-keramati@razi.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران Full name of responsible person - English: Dr. Mohammad Reza Keramati Full name of responsible person - Persian: دکتر محمدرضا کرامتی Position - English: Assistant Professor Position - Persian: استادیار Latest degree: specialist Area of specialty/work: 036 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Imam Khomeini hospital, Keshavarz blvd. Street address - Persian: تهران - انتهای بلوار کشاورز- بیمارستان امام خمینی(ره) City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1234567890 Phone: +98 21 2283 3381 Mobile: +98 912 114 7406 Fax: Email: mr-keramati@razi.tums.ac.ir Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
empty
The result of this study will be presented in the form of an article.
The result of this study will be presented in the form of an article.
empty
نتایج در قالب مقاله ارائه خواهد شد.
نتایج در قالب مقاله ارائه خواهد شد.
empty
Information can be accessed at any time.
Information can be accessed at any time.
empty
هر زمانی امکان دسترسی به اطلاعات وجود دارد.
هر زمانی امکان دسترسی به اطلاعات وجود دارد.
empty
All individuals.
All individuals.
empty
همه افراد.
همه افراد.
empty
In scientific studies and clinical treatment of related patients.
In scientific studies and clinical treatment of related patients.
empty
در مطالعات علمی و درمان بالینی بیماران مرتبط.
در مطالعات علمی و درمان بالینی بیماران مرتبط.
empty
Colorectal Research Center of Imam Khomeini Hospital, Tehran University Of Medical Science.
Contact the person in charge who is mentioned.
Colorectal Research Center of Imam Khomeini Hospital, Tehran University Of Medical Science. Contact the person in charge who is mentioned.
empty
مرکز تحقیقات کولورکتال بیمارستان امام خمینی (ره) دانشگاه تهران.
ارتباط با فرد مسوول ذکر شده.
مرکز تحقیقات کولورکتال بیمارستان امام خمینی (ره) دانشگاه تهران. ارتباط با فرد مسوول ذکر شده.
empty
Contact the colorectal center of the University of Tehran or contact the person in charge who is mentioned.
Contact the colorectal center of the University of Tehran or contact the person in charge who is mentioned.
empty
ارتباط با مرکز کولورکتال دانشگاه تهران یا ارتباط با فرد مسوول ذکر شده.
ارتباط با مرکز کولورکتال دانشگاه تهران یا ارتباط با فرد مسوول ذکر شده.
Protocol summary
Study aim
To compare complications after surgery in two groups of anterior repair versus resection and hand_sewn anastomosis.
Design
This is a prospective, randomized, double-blind clinical trial.
Settings and conduct
This study was performed at the colorectal surgery division of department of surgery at Tehran University of Medical Sciences between September 1, 2016 and December 1, 2018.
Participants/Inclusion and exclusion criteria
Inclusion criterion: patients with history of rectal cancer underwent low anterior resection surgery with protective loop ileostomy.
Exclusion criteria: immune deficiency; rectal anastomosis complications; history of abdominal surgery except rectal surgery.
Intervention groups
Intervention group A: 20 patients randomly selected and placed in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site were resected then anastomosed. Intervention group B : 20 patients randomly selected and placed in the anterior repair group. Anterior intestinal defect within the ileostomy site was repaired.
Main outcome variables
the first day of defecation / the first day of flatus / the first day of oral feeding / post operation early complications / post operation late complications
General information
Reason for update
In this study, participants, collectors of results and analyzers, were blind to the study. Wrongly، single-blind study was entered that should be corrected to double-blind study.
Acronym
IRCT registration information
IRCT registration number:IRCT201703158861N2
Registration date:2017-05-08, 1396/02/18
Registration timing:registered_while_recruiting
Last update:2022-06-25, 1401/04/04
Update count:1
Registration date
2017-05-08, 1396/02/18
Registrant information
Name
Mohammad Reza Keramati
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1657
Email address
mr-keramati@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-09-01, 1395/06/11
Expected recruitment end date
2017-07-01, 1396/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcomes and complications between anterior repair and resection-anastomosis of small intestine for closure of loop ileostomy performed in patients underwent rectal cancer resetion surgery
Public title
Comparison between anterior repair and resection-anastomosis of small intestine for closure of loop ileostomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of rectal cancer who had undergone curative low anterior resection for rectal cancer and a diverting protective loop ileostomy
Exclusion criteria:
history of immunodeficiency
complications associated with rectal anastomosis, including anastomotic leakage, para-anastomotic sinuses
previous abdominal operation other than rectal cancer surgery
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
patients were randomly assigned into two groups using randomly permuted blocks method. random allocation sequence was generated by the online platform www.randomization.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, participants, collectors of results and analyzers, were blind to the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
6th floor, Central building of Tehran University of Medical Sciences, Ghods St., Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1234567899
Approval date
2016-08-27, 1395/06/06
Ethics committee reference number
IR.TUMS.VCR.REC.1395.494
Health conditions studied
1
Description of health condition studied
Function of bowel
ICD-10 code
K59.9
ICD-10 code description
Functional intestinal disorder, unspecified
Primary outcomes
1
Description
the first day of defecation
Timepoint
daily up to one week
Method of measurement
question from the patient in daily ward visits
2
Description
the first day of flatus
Timepoint
daily up to one week
Method of measurement
question from the patient in daily ward visits
3
Description
the first day of oral feeding
Timepoint
daily up to one week
Method of measurement
stariting of oral diet based on surgeons decision
4
Description
post operation early complications
Timepoint
daily up to one month
Method of measurement
question from the patient in daily ward visits
5
Description
post operation late complications
Timepoint
monthly up to 6 months
Method of measurement
question from the patient in monthly clinic visits
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: 20 patients randomly selected and placed in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site were resected then anastomosed.
Category
Treatment - Surgery
2
Description
Intervention group B : 20 patients randomly selected and placed in the anterior repair group. Anterior intestinal defect within the ileostomy site was repaired.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences, Imam Khomeini Hospital
Full name of responsible person
Dr. Mohammad Reza Keramati
Street address
Imam Khomeini Hospital, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
123454567890
Phone
+98 21 6119 0000
Email
mr-keramati@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Researach deputy, School of Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Faculty of Medicine, Poor-sina St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 6119 0000
Email
mr-keramati@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Researach deputy, School of Medicine, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyed Mostafa Meshkati Yazd
Position
MD/ Resident of surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
123456789
Phone
+98 21 8860 7395
Fax
Email
mostafa.meshkati@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Keramati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 2283 3381
Fax
Email
mr-keramati@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Keramati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 2283 3381
Fax
Email
mr-keramati@razi.tums.ac.ir
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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The result of this study will be presented in the form of an article.
When the data will become available and for how long
Information can be accessed at any time.
To whom data/document is available
All individuals.
Under which criteria data/document could be used
In scientific studies and clinical treatment of related patients.
From where data/document is obtainable
Colorectal Research Center of Imam Khomeini Hospital, Tehran University Of Medical Science.
Contact the person in charge who is mentioned.
What processes are involved for a request to access data/document
Contact the colorectal center of the University of Tehran or contact the person in charge who is mentioned.