]>
IRCT20110530006640N6 IRCT 2020-07-21 Tehran University of Medical Sciences Surgical outcomes using bowel enema before benign gynecologic laparoscopic surgeries Surgical and Patient Outcomes Using Normal Saline Enema for Bowel Preparation Before Benign Gynecologic Laparoscopic Surgeries 2020-07-20 anticipated 112 Complete https://irct.ir/trial/49426 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random allocation methods were blocks that were designed by the epidemiologist using version 13 Stata software. The number of blocks is 6. The random allocation list of patients is only at the disposal of the clinic nurse.To hide the random allocation process, 112 treatment cards written in order. The cards are placed in sealed envelopment. When the physician determined that patient is eligible to enter the study, the nurse provides the physician with an envelope related to the type of intervention for check of the outcome, the commenting physician is unaware of the type of intervention. A statistical expert who is separated from the study is used to analyze the data. Due to the type of study, the patient will not be blind in this study, Blinding description: for evaluating the outcomes, The physician is unaware of the type of intervention. A statistical expert who is separated from the study is used to analyze the data. Due to the type of study, the patient will not be blind in this study. 3 Benign gynecology disease. Intervention 1: Intervention group:Patients eat light meals and fluids the night before surgery and they become NPO from 12 midnight . Intervention for this group is enema with normal saline once at 11 pm ( the night before the operation) and once at 6 am in the morning of operation. Intervention 2: Control group:Patients eat light meals and fluids the night before surgery and they become NPO from 12 midnight. 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 It is not yet known if there will be a plan to make this available
public Dr Zahra Asgari
Arash Hospital, Rashid street ,Resalat highway
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 8755 asgariza@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr Zahra Asgari
Arash Hospital, Rashid street ,Resalat highway
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 8755 asgariza@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for level 2 and 3 laparoscopic gynecologic surgeries 18 years 65 years Female Patients who are at risk for intestinal injury during laparoscopy and are candidates for complete bowel preparation before surgery such as : a history of multiple previous surgery with many adhesion, sever endometriosis in cul de sac and bowel/large uterus with adhesion in hysterectomy,cancer surgery, surgery in sever PTD with abcess. Patients who are candidates for level 1 laparoscopic surgeries such as TL and diagnostic laparoscopy. Patients who are candidates for level 4 laparoscopy surgeries such as lymphadenectomy,sever endometriosis, presacral neurectomy History of patients intestinal diseases such as IBS and colitis Severe obesity (BMI>35) N85 Other noninflammatory disorders of uterus, except cervix Treatment - Other Other Intervention group:Patients eat light meals and fluids the night before surgery and they become NPO from 12 midnight . Intervention for this group is enema with normal saline once at 11 pm ( the night before the operation) and once at 6 am in the morning of operation. Control group:Patients eat light meals and fluids the night before surgery and they become NPO from 12 midnight Surgeon's satisfaction from intraoperative visualization and bowel handling. Timepoint: Immediately after surgery. Method of measurement: Questionnaire. Complication of surgery such as viscoralinjury , fever, decrease of hemoglobin. Timepoint: Intraoperative and after surgery. Method of measurement: Patient File. Duration of surgery. Timepoint: End of surgery. Method of measurement: Cornometer. Duration of hospitalization. Timepoint: Time of the discharge from the hospital. Method of measurement: Day/Patient file. Tehran University of Medical Sciences Approved 2020-03-04 Ethics committee of Tehran University of Medical Sciences Research and Technology Dept, Sixth Floor of Central University Building, Corner of Quds Street, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)