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IRCT20220616055193N1 IRCT 2022-06-21 Tehran University of Medical Sciences Comparison of Betadine 10% and saline 5% on recurrence and complications of pulmonary hydatid cyst surgery Comparison of Povidone Iodine 10% and hypertonic saline 5% on their scolicidal effect during surgery and evaluation of recurrence and complications after pulmonary hydatid cyst surgery 2022-06-20 anticipated 60 Complete https://irct.ir/trial/64247 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation sequence and list of blocks will be obtained by the software consultant with statistics. The https://www.sealedenvelope.com website is a useful site for generating random sequences for block type randomization. This site is designed so that there is no limit to the number of random allocation groups.The block method is used to generate random allocation sequences.Patients will be selected according to the criteria of the researcher by sequential sampling method and will be randomly divided into two groups intervention and control. Randomization will be done in secret; after obtaining informed consent, which group (each intervention group) will be randomly assigned to each patient according to the specified blocks, as the participatory education for the patient and caregiver will take place, each patient's caregiver code will also be included. The random assignment sequence is obtained by the software's statistical and statistical expert.Patients and caregivers who have the inclusion criteria are enrolled by the researcher. Participants will be assigned randomly via specified blocking to hide the random assignment of the group names in the random assignment sequence. Participants were coded in order of entry into the study and assigned to the two intervention group, Blinding description: None of the patients and analysts are aware of the scolicidal agent used during surgery. The surgeons who is also responsible for postoperative follow up are aware of the type of agent used for each patient. N/A Hydatid cyst. Intervention 1: Intervention group: ِDuring surgery, following aspiration of the cyst, installation of a Povidone Iodine 10% as scolicidal agent is done to kill the parasite, then evacuation of the parasitic material and preservation or partial resection of the pericyst will be done. Intervention 2: Intervention group: ِDuring surgery, following aspiration of the cyst, installation of a Hypertonic saline 5% as scolicidal agent is done to kill the parasite, then evacuation of the parasitic material and preservation or partial resection of the pericyst will be done. 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 IPD will be provided upon request.
public Matin Vahedi
Sina hospital, Emam Khomeini st.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 mvahedi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Matin Vahedi
Sina hospital, Emam Khomeini st.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 mvahedi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who suffer from pulmonary hydatid cyst no limit no limit Both Ruptured or infected pulmonary hydatid cyst Concomitant non-pulmonary hydatid cyst History of hydatid cyst surgery in any organs B67.9 Echinococcosis, other and unspecified Treatment - Drugs Treatment - Drugs Intervention group: ِDuring surgery, following aspiration of the cyst, installation of a Povidone Iodine 10% as scolicidal agent is done to kill the parasite, then evacuation of the parasitic material and preservation or partial resection of the pericyst will be done. Intervention group: ِDuring surgery, following aspiration of the cyst, installation of a Hypertonic saline 5% as scolicidal agent is done to kill the parasite, then evacuation of the parasitic material and preservation or partial resection of the pericyst will be done. Post op air leakage. Timepoint: 1, 3, 6, 12 months post op. Method of measurement: Chest radiograph. Empyema formation. Timepoint: 1, 3, 6, 12 months post op. Method of measurement: Chest radiograph. Hydatid cyst recurrence. Timepoint: 1, 3, 6, 12 months post op. Method of measurement: Chest radiograph. Viability of scolex in hydatid cyst fluid. Timepoint: Post op. Method of measurement: Microscope slide. Tehran University of Medical Sciences Approved 2022-01-11 Research Ethics Committees of Imam Khomeini Hospital Complex - Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Tohid Squre Tehran Tehran Iran (Islamic Republic of)