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IRCT20221018056225N1 IRCT 2022-11-27 Bagheiat-allah University of Medical Sciences Efficacy of Low Level Laser Therapy on The Post Midline laparotomy Wound Pain Determining the effect of low-power laser therapy on midline laparotomy pain compared to placebo in upper and lower gastrointestinal surgeries 2022-10-22 anticipated 100 Complete https://irct.ir/trial/66408 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: By Using the online software www.randomizer.org, the patients were divided into two groups of 50 people, control and intervention, in a simple and individual way. Considering that the study is double-blind; The patient and the attending physician as pain evaluators will not know whether the patients belong to the control or intervention groups, Blinding description: Participants and pain evaluators, as well as the researcher of this study, by considering that the randomization of patients is done by the intervention provider, are not aware of which patient received the intervention and which patient received the placebo. N/A Condition 1: Patients who have been admitted to the Baqiyatallah educational and therapeutic center and have undergone midline laparotomy for elective upper and lower gastrointestinal surgery will be studied. Condition 2: Patients who have been admitted to the Baqiyatallah educational and therapeutic center and have undergone midline laparotomy for elective upper and lower gastrointestinal surgery will be studied. Condition 3: Patients who have been admitted to the Baqiyatallah educational and therapeutic center and have undergone midline laparotomy for elective upper and lower gastrointestinal surgery will be studied. Condition 4: Patients who have been admitted to the Baqiyatallah educational and therapeutic center and have undergone midline laparotomy for elective upper and lower gastrointestinal surgery will be studied. Condition 5: Patients who have been admitted to the Baqiyatallah educational and therapeutic center and have undergone midline laparotomy for elective upper and lower gastrointestinal surgery will be studied. Intervention 1: Intervention group: In addition to receiving the treatments of the first group, the intervention group is also treated with low-power laser. The distance of 2 cm from the wound after removing the surgical dressing will be 0.5 J/cm2 radiation dose. Considering that the radiation cross-section was considered to be 30 square centimeters; According to the formula t = (D. A) / P, the radiation time was calculated for 6 minutes each time. In total, the laser radiation will be done during the first three days after the operation for each patient, and its sequence will be such that the first dose of radiation It will be done after recovery and in the ward, and the next doses will be done at 24-hour intervals until the third day after the operation while in the hospital. Intervention 2: Control group: The first group (control) after the operation receive the usual treatments, including intravenous and oral pain relievers in case of pain, in addition to being treated with a low-power silent laser (Placebo). In total, during the first three days after After the operation, each patient will be treated with placebo three times, and the sequence will be such that the first time will be done after recovery and in the ward, and the next times will be done at intervals of 24 hours until the third day after the operation while in the hospital. will be done. Yes - There is a plan to make this available What will be shared: All data of this study according to the plan and after the completion of the data analysis so that the patients under study are not identifiable can be received by contacting the person in charge of scientific accountability in case of decision to publish the article in the ICMJE-related journals. When: The access period starts 6 months after the publication of the article in ICMJE-related journals. To whom: All researchers of university institutes who have published articles in ICMJE-related journals will be able to access the information of this study. Conditions: The data and analysis results of this study can only be used for inclusion in review studies. Where to obtain: To receive the data or the results of the analysis of this study, please refer to the person responsible for the scientific response of this study, Mr. Dr. Mohammad Madadi Imamchai, with the following contact information. Address:Baqiyatallah University of Medical Sciences, Department of General Surgery, Azam Ave, South Sheikh Bahai St, Molla Sadra Blvd, Vanak Square, Tehran. Mobile number: 00989104009204 Workplace phone number: 00982181267609 Fax number: 00982188033539 Email: geniusman68@yahoo.com Postal code: 1435915371 How to obtain: The request of receive information can be processed in a period of less than one week after checking the mentioned necessary conditions. Comments:
public Mohammad Madadi Emamchai
Baqiyatallah University of Medical Sciences, Department of General Surgery, Azam Ave, South Sheikh Bahai St, Mollasadra Blvd, Vanak Square, Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8126 7609 Geniusman68@yahoo.com Bagheiat-allah University of Medical Sciences scientific Mohammad Madadi Emamchai
Baqiyatallah University of Medical Sciences, Department of General Surgery, Azam Ave, South Sheikh Bahai St, Mollasadra Blvd, Vanak Square, Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8126 7609 Geniusman68@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients who are in the age range of 30 to 60 years. Patients who underwent midline laparotomy were selected for elective upper and lower gastrointestinal surgery. 30 years 60 years Both Patients who do not agree to participate in the study. Patients who, in addition to surgery, have other serious medical problems (ASA III-VI) or suffer from psychotic disorders or drug addiction. K42 K43 K46 K31 K25 Umbilical hernia Ventral hernia Unspecified abdominal hernia Other diseases of stomach and duodenum Gastric ulcer Treatment - Devices Placebo Intervention group: In addition to receiving the treatments of the first group, the intervention group is also treated with low-power laser. The distance of 2 cm from the wound after removing the surgical dressing will be 0.5 J/cm2 radiation dose. Considering that the radiation cross-section was considered to be 30 square centimeters; According to the formula t = (D. A) / P, the radiation time was calculated for 6 minutes each time. In total, the laser radiation will be done during the first three days after the operation for each patient, and its sequence will be such that the first dose of radiation It will be done after recovery and in the ward, and the next doses will be done at 24-hour intervals until the third day after the operation while in the hospital. Control group: The first group (control) after the operation receive the usual treatments, including intravenous and oral pain relievers in case of pain, in addition to being treated with a low-power silent laser (Placebo). In total, during the first three days after After the operation, each patient will be treated with placebo three times, and the sequence will be such that the first time will be done after recovery and in the ward, and the next times will be done at intervals of 24 hours until the third day after the operation while in the hospital. will be done. Midline laparotomy surgery site pain. Timepoint: Before beginning of the intervention, 24, 48, 72 hour's after beginning of the intervention. Method of measurement: visual analogue scale. Local complications of the laparotomy site. Timepoint: Before beginning of the intervention, 24, 48, 72 hour's after beginning of the intervention. Method of measurement: Inspection of the operation site. Serum Inflammatory factors. Timepoint: Before beginning of the intervention, 24, 48, 72 hour's after beginning of the intervention. Method of measurement: Taking daily blood tests. The amount of painkillers. Timepoint: Before beginning of the intervention, 24, 48, 72 hour's after the start of the intervention. Method of measurement: check the patient's medical record. Bagheiat-allah University of Medical Sciences Approved 2022-06-24 Research Ethics Committees of Baqiyatallah Hospital Baqiyatallah University of Medical Sciences, Baqiyatallah hospital, Department of General Surgery, Azam Ave, South Sheikh Bahai St, Molla Sadra Blvd, Vanak Square, Tehran Tehran Tehran Iran (Islamic Republic of)