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IRCT20230130057275N1 IRCT 2023-03-14 Kerman University of Medical Sciences Investigating the effect of drain in pain control after laparoscopic cystectomy surgery in women referred to Afzalipur Hospital, Kerman Comparing the effectiveness of drain in pain control in women who need laparoscopic ovarian cystectomy surgery in two groups with drain and without drain 2023-01-22 anticipated 260 Complete https://irct.ir/trial/68608 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Ovarian cyst. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Nafiseh Seyedi
Unit 4, Venus Building, Alley 11, Houshang Moradi St., Republic Blvd.
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3212 0211 Nafiseh.seyedi.2020@Gmail.com Kerman University of Medical Sciences scientific Nafiseh Seyedi
Unit 4, Venus Building, Alley 11, Houshang Moradi St., Republic Blvd.
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3212 0211 Nafiseh.seyedi2020@Gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) 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 18 years 62 years Female 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 N83.29 Other ovarian cysts Treatment - Surgery Treatment - Surgery 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. 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. 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 ). Time to work the bowels. Timepoint: Last hours after surgery. Method of measurement: data collection form through patient declaration. Days of stay in the hospitalization. Timepoint: hospitalization days after surgery. Method of measurement: Investigation of Medical Record. 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. Kerman University of Medical Sciences Approved 2023-01-21 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus,Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)