Comparing the effectiveness of drain in pain control in women who need laparoscopic ovarian cystectomy surgery in two groups with drain and without drain
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Protocol summary
A clinical trial with a control group, with parallel groups, a blind strain, randomized, on nodes of 30 intervention and control people, rand function of Excel software was used for randomization.
A clinical trial with a control group, with parallel groups, a blind strain, randomized, on nodes of 130 intervention and control people, rand function of Excel software was used for randomization.
A clinical trial with a control group, with parallel groups, a blind strain, randomized, on nodes of 30130 intervention and control people, rand function of Excel software was used for randomization.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سویه کور، تصادفی شده، بر روی گروه های ۳۰ نفره مداخله و کنترل، برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سویه کور، تصادفی شده، بر روی گروه های 130 نفره مداخله و کنترل، برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سویه کور، تصادفی شده، بر روی گروه های ۳۰130 نفره مداخله و کنترل، برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد.
60 women aged 18 to 62 who are candidates for laparoscopic surgery for ovarian cystectomy in Afzalipur Hospital, Kerman, will undergo surgery after being randomly assigned to control and intervention groups of 30 people and after the end of the surgery in the intervention group (with a drain), the Hemovac type drain is placed in place for 24 hours and the drain is removed after 24 hours.In the group without drain, the surgical procedures are completely similar.But in the end, the surgery will end without the insertion of a drain.
260 women aged 18 to 62 who are candidates for laparoscopic surgery for ovarian cystectomy in Afzalipur Hospital, Kerman, will undergo surgery after being randomly assigned to control and intervention groups of 130 people and after the end of the surgery in the intervention group (with a drain), the Hemovac type drain is placed in place for 24 hours and the drain is removed after 24 hours.In the group without drain, the surgical procedures are completely similar.But in the end, the surgery will end without the insertion of a drain.
60260 women aged 18 to 62 who are candidates for laparoscopic surgery for ovarian cystectomy in Afzalipur Hospital, Kerman, will undergo surgery after being randomly assigned to control and intervention groups of 30130 people and after the end of the surgery in the intervention group (with a drain), the Hemovac type drain is placed in place for 24 hours and the drain is removed after 24 hours.In the group without drain, the surgical procedures are completely similar.But in the end, the surgery will end without the insertion of a drain.
60 زن 18 تا 62 ساله که در بیمارستان افضلی پور کرمان کاندید جراحی لاپاراسکوپیک جهت سیستکتومی تخمدان می باشند، پس از تعلق تصادفی به گروه های ۳۰ نفره کنترل و مداخله تحت جراحی قرار خواهند گرفت و پس از پایان جراحی در گروه مداخله (دارای درن)، درن از نوع Hemovac به مدت ۲۴ ساعت در محل قرار داده می شود و پس از ۲۴ ساعت درن برداشته می شود. در گروه بدون درن نیز مراحل جراحی کاملا مشابه است. اما در نهایت بدون تعبیه درن، جراحی پایان خواهد پذیرفت.
260 زن 18 تا 62 ساله که در بیمارستان افضلی پور کرمان کاندید جراحی لاپاراسکوپیک جهت سیستکتومی تخمدان می باشند، پس از تعلق تصادفی به گروه های 130 نفره کنترل و مداخله تحت جراحی قرار خواهند گرفت و پس از پایان جراحی در گروه مداخله (دارای درن)، درن از نوع Hemovac به مدت ۲۴ ساعت در محل قرار داده می شود و پس از ۲۴ ساعت درن برداشته می شود. در گروه بدون درن نیز مراحل جراحی کاملا مشابه است. اما در نهایت بدون تعبیه درن، جراحی پایان خواهد پذیرفت.
60260 زن 18 تا 62 ساله که در بیمارستان افضلی پور کرمان کاندید جراحی لاپاراسکوپیک جهت سیستکتومی تخمدان می باشند، پس از تعلق تصادفی به گروه های ۳۰130 نفره کنترل و مداخله تحت جراحی قرار خواهند گرفت و پس از پایان جراحی در گروه مداخله (دارای درن)، درن از نوع Hemovac به مدت ۲۴ ساعت در محل قرار داده می شود و پس از ۲۴ ساعت درن برداشته می شود. در گروه بدون درن نیز مراحل جراحی کاملا مشابه است. اما در نهایت بدون تعبیه درن، جراحی پایان خواهد پذیرفت.
General information
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260
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260 patients were examined.
260 patients were examined.
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تعداد 260 بیمار مورد بررسی قرار گرفت.
تعداد 260 بیمار مورد بررسی قرار گرفت.
The sample number of 60 people will be selected as available and will be randomly divided into two groups of 30 people using random list software. Informed consent will be obtained from all patients of both groups. After the research is approved by the ethics committee, the subjects will be divided into two groups completely randomly using envelopes. For this purpose, envelopes are considered for the number of patients and the code related to the study group is placed inside the envelopes, then with each patient's visit, a specific code is assigned to each patient and his code is written on a random envelope. to be The envelope for each person will be opened at the beginning of the surgery, and based on that, each person will be assigned to the desired group. Randomization will be done by someone outside the research, this person and no other person will be aware of the contents inside the envelopes. Due to the nature of the study, it is not possible to blind the interventionist, but the surgeon was not aware of the patient group until the end of the study, and in order to reduce and minimize the bias, other information will be collected by another researcher after the surgery.
The sample number of 260 people will be selected as available and will be randomly divided into two groups of 130 people using random list software. Informed consent will be obtained from all patients of both groups. After the research is approved by the ethics committee, the subjects will be divided into two groups completely randomly using envelopes. For this purpose, envelopes are considered for the number of patients and the code related to the study group is placed inside the envelopes, then with each patient's visit, a specific code is assigned to each patient and his code is written on a random envelope. to be The envelope for each person will be opened at the beginning of the surgery, and based on that, each person will be assigned to the desired group. Randomization will be done by someone outside the research, this person and no other person will be aware of the contents inside the envelopes. Due to the nature of the study, it is not possible to blind the interventionist, but the surgeon was not aware of the patient group until the end of the study, and in order to reduce and minimize the bias, other information will be collected by another researcher after the surgery.
The sample number of 60260 people will be selected as available and will be randomly divided into two groups of 30130 people using random list software. Informed consent will be obtained from all patients of both groups. After the research is approved by the ethics committee, the subjects will be divided into two groups completely randomly using envelopes. For this purpose, envelopes are considered for the number of patients and the code related to the study group is placed inside the envelopes, then with each patient's visit, a specific code is assigned to each patient and his code is written on a random envelope. to be The envelope for each person will be opened at the beginning of the surgery, and based on that, each person will be assigned to the desired group. Randomization will be done by someone outside the research, this person and no other person will be aware of the contents inside the envelopes. Due to the nature of the study, it is not possible to blind the interventionist, but the surgeon was not aware of the patient group until the end of the study, and in order to reduce and minimize the bias, other information will be collected by another researcher after the surgery.
تعداد نمونه ۶۰ نفر بروش نمونه گیری به صورت در دسترس انتخاب می شوند و به طور تصادفی با استفاده از نرم افزار رندوم لیست به دوگروه ۳۰ نفری تقسیم خواهند شد. از کلیه بیماران هر دو گروه رضایت آگاهانه اخذ خواهد شد پس از تائید پژوهش توسط کمیته اخلاق افراد مورد مطالعه به صورت کاملا تصادفی و با استفاده از پاکت به دو گروه تقسیم خواهد شد. بدین منظور به تعداد بیماران پاکت نامه در نظر گرفته شده و در درون پاکت ها کد مربوط به گروه مورد مطالعه قرار داده می شود، سپس با مراجعه هر بیمار به هر بیمار یک کد اختصاصی تعلق گرفته و کد او بر روی یک پاکت تصادفی نوشته می شود. پاکت مربوط به هر فرد در شروع انجام جراحی باز خواهد شد و بر اساس ان تلعق هر فرد به گروه مورد نظر مشخص میگردد. تصادفی سازی توسط فردی خارج از پژوهش انجام خواهد شد، این فرد و هیچ فرد دیگری از محتویات داخل پاکت ها آگاه نخواهد بود.
تعداد نمونه 260 نفر به روش نمونه گیری به صورت در دسترس انتخاب می شوند و به طور تصادفی با استفاده از نرم افزار رندوم لیست به دو گروه 130 نفری تقسیم خواهند شد. از کلیه بیماران هر دو گروه رضایت آگاهانه اخذ خواهد شد پس از تائید پژوهش توسط کمیته اخلاق افراد مورد مطالعه به صورت کاملا تصادفی و با استفاده از پاکت به دو گروه تقسیم خواهد شد. بدین منظور به تعداد بیماران پاکت نامه در نظر گرفته شده و در درون پاکت ها کد مربوط به گروه مورد مطالعه قرار داده می شود، سپس با مراجعه هر بیمار به هر بیمار یک کد اختصاصی تعلق گرفته و کد او بر روی یک پاکت تصادفی نوشته می شود. پاکت مربوط به هر فرد در شروع انجام جراحی باز خواهد شد و بر اساس ان تلعق هر فرد به گروه مورد نظر مشخص میگردد. تصادفی سازی توسط فردی خارج از پژوهش انجام خواهد شد، این فرد و هیچ فرد دیگری از محتویات داخل پاکت ها آگاه نخواهد بود.
تعداد نمونه ۶۰260 نفر بروشبه روش نمونه گیری به صورت در دسترس انتخاب می شوند و به طور تصادفی با استفاده از نرم افزار رندوم لیست به دوگروه ۳۰دو گروه 130 نفری تقسیم خواهند شد. از کلیه بیماران هر دو گروه رضایت آگاهانه اخذ خواهد شد پس از تائید پژوهش توسط کمیته اخلاق افراد مورد مطالعه به صورت کاملا تصادفی و با استفاده از پاکت به دو گروه تقسیم خواهد شد. بدین منظور به تعداد بیماران پاکت نامه در نظر گرفته شده و در درون پاکت ها کد مربوط به گروه مورد مطالعه قرار داده می شود، سپس با مراجعه هر بیمار به هر بیمار یک کد اختصاصی تعلق گرفته و کد او بر روی یک پاکت تصادفی نوشته می شود. پاکت مربوط به هر فرد در شروع انجام جراحی باز خواهد شد و بر اساس ان تلعق هر فرد به گروه مورد نظر مشخص میگردد. تصادفی سازی توسط فردی خارج از پژوهش انجام خواهد شد، این فرد و هیچ فرد دیگری از محتویات داخل پاکت ها آگاه نخواهد بود.
Recruitment centers
#1
Name of recruitment center - English: Afzalipour Hospital- Kerman University of Medical Sciences
Name of recruitment center - Persian: بیمارستان افضلی پور - دانشگاه علوم پزشکی کرمان
Full name of responsible person - English: Ghazal Mansouri
Full name of responsible person - Persian: غزال منصوری
Street address - English: Afzalipour Hospital
Street address - Persian: بزرگراه امام خمینی ( ره )، جنب دانشگاه شهید باهنر، مرکز آموزشی درمانی افضلی پور
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616913355
Phone: +98 34 3132 8000
Fax: +98 34 3132 5830
Email: dr_mansouri93@yahoo.com
Web page address:
Name of recruitment center - English: Afzalipour Hospital
Name of recruitment center - Persian: بیمارستان افضلی پور
Full name of responsible person - English: Ghazal Mansouri
Full name of responsible person - Persian: غزال منصوری
Street address - English: Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center
Street address - Persian: بزرگراه امام خمینی ( ره )، جنب دانشگاه شهید باهنر، مرکز آموزشی درمانی افضلی پور
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616913355
Phone: +98 34 3132 8000
Fax: +98 34 3132 5830
Email: dr_mansouri93@yahoo.com
Web page address:
Name of recruitment center - English: Afzalipour Hospital- Kerman University of Medical Sciences Name of recruitment center - Persian: بیمارستان افضلی پور - دانشگاه علوم پزشکی کرمان Full name of responsible person - English: Ghazal Mansouri Full name of responsible person - Persian: غزال منصوری Street address - English: Afzalipour HospitalImam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center Street address - Persian: بزرگراه امام خمینی ( ره )، جنب دانشگاه شهید باهنر، مرکز آموزشی درمانی افضلی پور City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7616913355 Phone: +98 34 3132 8000 Fax: +98 34 3132 5830 Email: dr_mansouri93@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Reza Malekpour Afshar
Full name of responsible person - Persian: رضا ملک پورافشار
Street address - English: Kerman University of Medical Sciences
Street address - Persian: دانشگاه علوم پزشکی کرمان
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7619813159
Phone: +98 34 3226 3855
Fax:
Email: KMU_RESEARCH@YAHOO.COM
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Reza Malekpour Afshar
Full name of responsible person - Persian: رضا ملک پورافشار
Street address - English: Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Street address - Persian: کرمان، ابتدای محور هفت باغ علوی، پردیس دانشگاه علوم پزشکی
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7619813159
Phone: +98 34 3226 3855
Fax:
Email: KMU_RESEARCH@YAHOO.COM
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Reza Malekpour Afshar Full name of responsible person - Persian: رضا ملک پورافشار Street address - English: Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Street address - Persian: کرمان، ابتدای محور هفت باغ علوی، پردیس دانشگاه علوم پزشکی کرمان City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7619813159 Phone: +98 34 3226 3855 Fax: Email: KMU_RESEARCH@YAHOO.COM Web page address:
Protocol summary
Study aim
Determining the effect of drain in pain control after laparoscopic ovarian cystectomy surgery in women at Afzalipur Hospital, Kerman.
Design
A clinical trial with a control group, with parallel groups, a blind strain, randomized, on nodes of 130 intervention and control people, rand function of Excel software was used for randomization.
Settings and conduct
This study will be conducted in Afzalipur Hospital, Kerman, on patients with ovarian cysts. After randomizing the patients, the patient group will be determined using a sealed envelope, and the patients will be blinded to the study
Participants/Inclusion and exclusion criteria
Women aged 18 to 62 without any comorbidities who will undergo cystectomy surgery for ovarian cysts in Afzalipur Hospital and have no complications during the operation and are fully awake will be included in the study after obtaining written informed consent.
People with a history of abdominal and thoracic surgery, psychiatric patients, those with chronic pain in the abdomen, pelvis, systemic disease, fallopian tube abscess (before or during surgery), shoulder pain and trauma, and patients whose laparoscopic surgery is changed to laparotomy and Patients who require a drain due to organ damage, bleeding or infection will be excluded from the study.
Intervention groups
260 women aged 18 to 62 who are candidates for laparoscopic surgery for ovarian cystectomy in Afzalipur Hospital, Kerman, will undergo surgery after being randomly assigned to control and intervention groups of 130 people and after the end of the surgery in the intervention group (with a drain), the Hemovac type drain is placed in place for 24 hours and the drain is removed after 24 hours.In the group without drain, the surgical procedures are completely similar.But in the end, the surgery will end without the insertion of a drain.
Main outcome variables
Patient pain score after surgery
General information
Reason for update
260 patients were examined.
Acronym
IRCT registration information
IRCT registration number:IRCT20230130057275N1
Registration date:2023-03-14, 1401/12/23
Registration timing:registered_while_recruiting
Last update:2023-08-09, 1402/05/18
Update count:1
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Nafiseh Seyedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3212 0211
Email address
nafiseh.seyedi2020@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-22, 1401/11/02
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of drain in pain control in women who need laparoscopic ovarian cystectomy surgery in two groups with drain and without drain
Public title
Investigating the effect of drain in pain control after laparoscopic cystectomy surgery in women referred to Afzalipur Hospital, Kerman
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18 to 62 without any comorbidities who will undergo laparoscopic ovarian (LOC) for ovarian cysts from January to March 1401 in Afzalipur University Hospital and have no complications during the operation will be studied
Full consciousness
providing informed written consent
not using analgesic before surgery
Exclusion criteria:
History of abdominal and thoracic surgery
psychiatric patients
those with chronic pain in the abdomen, pelvis, systemic disease, fallopian tube abscess (before or during surgery), shoulder pain and trauma
Patients whose laparoscopic surgery is changed to laparotomy
Patients who need a drain due to organ damage, bleeding or infection will be excluded from the study
Patients who develop complications (fever, bleeding, infection at the incision site, atelectasis, subcutaneous emphysema) will also be excluded from the pain intensity study and will be studied only to compare and determine the effect of the drain on the complications
Age
From 18 years old to 62 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
260
Randomization (investigator's opinion)
Randomized
Randomization description
The sample number of 260 people will be selected as available and will be randomly divided into two groups of 130 people using random list software. Informed consent will be obtained from all patients of both groups. After the research is approved by the ethics committee, the subjects will be divided into two groups completely randomly using envelopes. For this purpose, envelopes are considered for the number of patients and the code related to the study group is placed inside the envelopes, then with each patient's visit, a specific code is assigned to each patient and his code is written on a random envelope. to be The envelope for each person will be opened at the beginning of the surgery, and based on that, each person will be assigned to the desired group. Randomization will be done by someone outside the research, this person and no other person will be aware of the contents inside the envelopes. Due to the nature of the study, it is not possible to blind the interventionist, but the surgeon was not aware of the patient group until the end of the study, and in order to reduce and minimize the bias, other information will be collected by another researcher after the surgery.
Blinding (investigator's opinion)
Single blinded
Blinding description
Randomization will be done by someone outside the research, this person and no other person will be aware of the contents inside the envelopes. Due to the nature of the study, it is not possible to blind the interventionist, but the surgeon was not aware of the patient group until the end of the study, and in order to reduce and minimize the bias, other information will be collected by another researcher after the surgery.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.KMU.AH.REC.1401.248
Health conditions studied
1
Description of health condition studied
Ovarian cyst
ICD-10 code
N83.29
ICD-10 code description
Other ovarian cysts
Primary outcomes
1
Description
The primary outcome of the study is the pain score, which is collected through the VAS questionnaire.
Timepoint
VAS pain questionnaire will be measured at 4 hours, 12 hours, 24 hours, 42 hours and 72 hours after surgery.
Method of measurement
Visual Analog Scale for Pain (VAS )
Secondary outcomes
1
Description
Time to work the bowels
Timepoint
Last hours after surgery
Method of measurement
data collection form through patient declaration
2
Description
Days of stay in the hospitalization
Timepoint
hospitalization days after surgery
Method of measurement
Investigation of Medical Record
3
Description
location of pain
Timepoint
4 hours, 12 hours, 24 hours, 42 hours and 72 hours after surgery
Method of measurement
History and interview with the patient and physical examination
Intervention groups
1
Description
Intervention group (with drain): Patients will be anesthetized before the start of laparoscopy. The patients will be operated by a surgical team. All patients will be given intravenous cefazolin 1 gram as a prophylactic antibiotic after induction of general anesthesia. General anesthesia will be performed using common anesthetic drugs used in Afzalipur Kerman Hospital. Laparoscopic surgery will be performed using carbon dioxide gas and three ports or incisions will be made as follows. One 10.5 mm incision below the umbilical cord to enter the telescope and two 5.5 mm incisions through the outer edge of the rectum to enter the surgical instrument. CO2 gas enters the peritoneum with an initial pressure of 12 to 16 mm Hg. After the end of the surgery in this group, before closing the skin and suture of the surgical site, a Hemovac type drain was inserted through a 5.5 mm side incision without any additional incision and placed in a suitable place in the surgical site. After that, the rest of the incision is sutured with surgical thread. The drain is placed in place for 24 hours and after that, the drain will be removed.
Category
Treatment - Surgery
2
Description
Control group (without drain): Patients will be operated by a surgical team. All patients will be given intravenous cefazolin 1 gram as a prophylactic antibiotic after induction of general anesthesia. General anesthesia will be performed using common anesthetic drugs used in Afzalipur Kerman Hospital. Laparoscopic surgery will be performed using carbon dioxide gas and three ports or incisions will be made as follows. One 10.5 mm incision below the umbilical cord to enter the telescope and two 5.5 mm incisions through the outer edge of the rectum to enter the surgical instrument. CO2 gas enters the peritoneum with an initial pressure of 12 to 16 mm Hg. After the end of the surgery in the control group, the surgery will be completed without the insertion of the drain.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Ghazal Mansouri
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Fax
+98 34 3132 5830
Email
dr_mansouri93@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
KMU_RESEARCH@YAHOO.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?