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IRCT20230208057358N1 IRCT 2023-02-11 Hamedan University of Medical Sciences Technical comparison of intercostal flank and subcostal flank incisions in open kidney surgeries Technical comparison of intercostal flank and subcostal flank incisions in open kidney surgeries 2023-02-28 anticipated 64 Complete https://irct.ir/trial/68486 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: The studied samples will be selected as available and randomly divided into intervention groups. The samples are divided into two equal groups of intercostal flank incision (A) and subcostal flank incision (B) using the block randomization method. Our randomization tool in this study is random allocation software version 1, which is available at https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html. The information required by the software, including the number of groups (2 groups), the name of each group (A=1, B=2), sample size (64 patients) and block size (4) were entered to generate a random sequence and based on that , 16 blocks of 4 including two groups A and B were randomly designed using the software. In this study, we will use the concealment of random allocation for the purpose of concealment, which refers to the method used to perform a random sequence on the participants in the study, in such a way that the allocated group is not known before the allocation of the individual. In this method, each of the generated random sequences is recorded on a card and the cards will be placed in sealed opaque envelopes in order. In order to maintain a random sequence on the outer surface of the envelopes, numbering will be done in the same order. Finally, the lid of the letter envelopes will be glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: Participants will not know which surgical incision technique was used for them. N/A open kidney surgeries; flank hernia and bulge. Intervention 1: Intervention group: Flank intercostal cut (lateral oblique cut between the 11th and 12th ribs from the rectus sheath to the sacrospinalis muscle). Intervention 2: Control group: Subcostal flank incision (diagonal flank incision that is made about 2 cm below the 12th rib from the rectus sheath to the Sacrospinalis muscle). Yes - There is a plan to make this available What will be shared: In this study, it will find part of the same data as the information related to the main outcome, follow-ups, and background and demographic information of the participants with the aim of researching the publication. When: No decision has been made yet To whom: The results of this study will be available for researchers working in academic and scientific institutions, surgeons, residents and nurses working in the clinical field. Conditions: No decision has been made yet Where to obtain: To receive documents or get guidance, people can access the email of the person responsible for this study at the address below. Email address: al.abdi@edu.umsha.ac.ir How to obtain: No decision has been made yet Comments:
public Alireza Abdi
No 110, Imam Khomeini St., Maryanaj
hamadan Iran (Islamic Republic of) 6514144868 +98 81 3426 3597 al.abdi@edu.umsha.ac.ir Hamedan University of Medical Sciences scientific Alireza Abdi
No 110, Imam Khomeini St., Maryanaj
hamadan Iran (Islamic Republic of) 6514144868 +98 81 3426 3597 al.abdi@edu.umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients are candidates for open kidney surgery Willingness and consent to participate in the study Body mass index (BMI) between 18 and 30 18 years 55 years Both Re-operation with a cut on the previous incision Presence of abdominal wall hernia at the same time The person participating in the study is diabetic Being pregnant if the person participating in the study is a woman History of chronic obstructive pulmonary disease History of peritoneal dialysis History of previous hernia History of taking immunosuppressive drugs History of smoking and drug use History of connective tissue diseases and disorders Treatment - Surgery Treatment - Surgery Intervention group: Flank intercostal cut (lateral oblique cut between the 11th and 12th ribs from the rectus sheath to the sacrospinalis muscle) Control group: Subcostal flank incision (diagonal flank incision that is made about 2 cm below the 12th rib from the rectus sheath to the Sacrospinalis muscle) Hernia and bulge after surgery. Timepoint: At times 3 and 6 months after the operation. Method of measurement: Clinical examination by a specialist surgeon and medical imaging. Pain after surgery. Timepoint: in 1 and 3 months after surgery. Method of measurement: Visual analog scale (VAS). The amount of painkillers received. Timepoint: At the time of discharge from the hospital. Method of measurement: Injection syringe (in milliliters). Surgical incision scar. Timepoint: At times 3 and 6 months after the operation. Method of measurement: Manchester scar scale. Incision time. Timepoint: During surgery. Method of measurement: Digital clock (in minutes). Closure time. Timepoint: During surgery. Method of measurement: Digital clock (in minutes). Exposure of the operative site. Timepoint: Immediately after surgery. Method of measurement: Likert scale - scoring from one (suitable and sufficient exposure - highest satisfaction) to five (inappropriate and poor exposure - lowest satisfaction) -. Quality of Life. Timepoint: Once before surgery and 1 and 3 months after surgery. Method of measurement: SF-36 questionnaire. Hamedan University of Medical Sciences Approved 2023-01-27 Ethics committee of Hamadan University of Medical Sciences Vice-chancellor for research and technology, In front of the Mardom park, Shahid Fahmideh steet, Hamadan Hamadan Hamadan Iran (Islamic Republic of)