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IRCT20220822055769N1 IRCT 2022-08-31 Hamedan University of Medical Sciences Comparison of two Lower midline and Pfannenstiel skin incisions in open prostatectomy Technical comparison of two Lower midline and Pfannenstiel skin incisions in open prostatectomy: randomized clinical trial 2022-09-23 anticipated 62 Complete https://irct.ir/trial/65426 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the patients, we will use the block randomization method of four. For this purpose, we prepare four sheets of paper. On two sheets we write the letter P meaning "Pfannenstiel" and on the other two sheets we write the letter L meaning "Lower midline". We mix the sheets together and put them in the desk drawer. With the referral of each of the qualified patients, one of the sheets will be randomly drawn and based on this drawn sheet, L or P, they will be assigned to one of the two treatment groups. It should be noted that the drawn cards will not be returned to the drawer until all four cards have been drawn. After randomly pulling out all four sheets, all the sheets are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size is reached, Blinding description: In order to blind the data analyst, all the data obtained from the study will be given to the analyst without specifying the type of cut. In order to blind the participants, general explanations about the study will be given when obtaining the consent letter, and the participants will not be aware of their cut type. N/A Benign prostatic hyperplasia. Intervention 1: Intervention group P: Use of Pfannenstiel incision for simple open prostatectomy patients surgery-In this group, the Pfannenstiel skin incision, which is a lower transverse abdominal incision, is used for eligible patients presenting for open prostatectomy. Cutting is done using a scalpel blade. In the next steps, electrocautery, gauze, and Lon gauze are used for blood sampling. Intervention 2: Intervention group L: Use of lower midline incision for simple open prostatectomy patients surgery- In this group, the lower midline skin incision, which is a lower vertical abdominal incision, is used for eligible patients presenting for open prostatectomy. Cutting is done using a scalpel blade. In the next steps, electrocautery, gauze, and Lon gauze are used for blood sampling. Yes - There is a plan to make this available What will be shared: All personal data is shared after de-identifying individuals. including demographic data and data related to operation time, incision time, time to reach the bladder, enucleation time, postoperative pain level, painkiller received, and postoperative scar When: The data will be shared three months after the results are published. To whom: All researchers can take action to receive data. Conditions: The data is provided under the condition that they first have a clear purpose for using the data. Second, wherever these data are to be used, the primary source of the data should be mentioned. Where to obtain: To receive data, you can refer to the email address below. Behzadiman@yahoo.com How to obtain: After sending the request to the email address, the data will be sent as soon as possible. Comments:
public Mojtaba Moradzadeh
Eram
Tabriz Iran (Islamic Republic of) 5147665765 +98 41 3230 1479 m.moradzade@edu.umsha.ac.ir Hamedan University of Medical Sciences scientific Behzad Imani
Fahmide Blvr
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 1014 behzadiman@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Ability to communicate with the researcher Absence of an underlying disease disrupting the research results, such as immune system diseases or coagulation disorders Not taking immunosuppressive drugs Absence of psychological diseases no limit no limit Male Unwillingness to participate in the study Failure to sign informed consent Taking opioid drugs or substances N40 Enlarged prostate Treatment - Surgery Treatment - Surgery Intervention group P: Use of Pfannenstiel incision for simple open prostatectomy patients surgery-In this group, the Pfannenstiel skin incision, which is a lower transverse abdominal incision, is used for eligible patients presenting for open prostatectomy. Cutting is done using a scalpel blade. In the next steps, electrocautery, gauze, and Lon gauze are used for blood sampling. Intervention group L: Use of lower midline incision for simple open prostatectomy patients surgery- In this group, the lower midline skin incision, which is a lower vertical abdominal incision, is used for eligible patients presenting for open prostatectomy. Cutting is done using a scalpel blade. In the next steps, electrocautery, gauze, and Lon gauze are used for blood sampling. Time of surgery. Timepoint: During surgery. Method of measurement: By using an electronic timer, the operation time is measured so that when the skin incision is started, the surgeon gives the order (start) and the researcher starts measuring the time, and after the last skin suture is applied and the last adhesive dressing is applied, The orders (time 1) and (time 2) will be issued by the surgeon. In this way, two different times for surgery will be measured. Time of incision. Timepoint: During surgery. Method of measurement: By using an electronic timer, the incision time is measured so that when the skin incision starts, the surgeon gives the order (start) and the researcher starts measuring the time, and when the rectus sheath incision starts, the surgeon will give the order (end). In this way, the incision time will be measured. Time of enucleation. Timepoint: During surgery. Method of measurement: Using an electronic timer, the enucleation time is measured so that when the surgeon's hand enters the bladder for enucleation, the surgeon gives the order (start) and the researcher starts measuring the time, and when all the desired parts of the prostate come out. The surgeon will give the order (end). In this way, the enucleation time will be measured. After surgery pain. Timepoint: Immediately after surgery, 12 hours after surgery and 24 hours after surgery. Method of measurement: Visual analogue scale will be used to evaluate postoperative pain. The scale consists of a 10 cm line with descriptive words at both ends. In most pain studies, the range is written from "no pain" to "severe pain" or "worst pain ever." In the current study, the phrases "no pain" to "the worst pain ever" will be used on both sides of the mentioned line. Patients estimate their pain level by placing a mark on the line. Then the distance from the "no pain" point is measured with a ruler. In order to validate the data obtained, a single ruler will be used throughout the data collection. After surgery scar. Timepoint: One month after surgery. Method of measurement: The Manchester scar scale will be used to evaluate the scar after the operation, which includes six items: color, appearance, texture, scar curvature, shiny surface, and the patient's general opinion. Each of the first four items is given a score between 1 and 4. Matt or shiny scar is recorded (score 1 and 2, respectively), and the patient's general opinion is measured on a 0-10 visual analogue scale. On one side of the line, the phrase (excellent) will be recorded and on the other side, the phrase (poor) will be recorded. The total marks are obtained from 6 items. Higher values ​​indicate worse scars. Therefore, to measure the general opinion of the patient, the distance of the point recorded by the patient to the end (excellent) will be measured. The amount of painkillers received. Timepoint: During hospital stay. Method of measurement: The amount of painkiller received will be calculated in milliliters and an injection syringe manufactured by a single company will be used for measurement. Hamedan University of Medical Sciences Approved 2022-08-20 Ethics committee of Hamedan University of Medical Sciences Ethics Committee in Research, Research and Technology Committee, University of Medical Sciences, Fahmideh Blvd Hamedan Hamadan Iran (Islamic Republic of)