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IRCT20170610034428N1 IRCT 2019-06-08 Ahvaz University of Medical Sciences Stapled Hemorrhoidectomy on Patients Clinical Outcomes Comparison of Two Methods of Hemorrhoid Surgery: Stapled Hemorrhoidectomy and Conventional Surgery on Patients Clinical Outcomes 2017-06-25 anticipated 40 Complete https://irct.ir/trial/39597 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block. Block size =4. possible ways = 6. Permuted block randomization=15. Block selection numbers with random numbers table. Unit randomization: individual. A person who specifies the sequence is the executor of plan not the surgeon,the designer must hide the information from the surgeon. N/A hemorrhoid. Intervention 1: Intervention group: patients in this group undergo stapled hemorrhoidectomy. This is done in 5 steps and in the following order: 1. Slow anal canal dilatation for inserting the device with a dilator. 2. Speculum insertion. 3. Creata a pure-String Suture. 4. Insert Stapler. 5. Bleeding control in the anastomosis line. Intervention 2: Control group: patients in this group underwent conventional hemorrhoidectomy.In this procedure, the entire pocket is removed and the mucosa is close to the cut line and the rest of the skin wounds are kept open. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Heydar Ghiasi
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3337 4598 ghiasi.h@ajums.ac.ir Ahvaz University of Medical Sciences scientific Heydar Ghiasi
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3337 4598 ghiasi.h@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 60 years Patients with grade 3 or 4 internal hemorrhoids 18 years 60 years Both Thrombosed hemorrhoids Drug addiction History of previous anorectal surgery Fisher or an anal fistula K64.1 Second degree hemorrhoids Treatment - Surgery Treatment - Surgery Intervention group: patients in this group undergo stapled hemorrhoidectomy. This is done in 5 steps and in the following order: 1. Slow anal canal dilatation for inserting the device with a dilator. 2. Speculum insertion. 3. Creata a pure-String Suture. 4. Insert Stapler. 5. Bleeding control in the anastomosis line. Control group: patients in this group underwent conventional hemorrhoidectomy.In this procedure, the entire pocket is removed and the mucosa is close to the cut line and the rest of the skin wounds are kept open. Pain. Timepoint: One, two and three days after surgery. Method of measurement: Visual Analog Scale. Anal sphincter pressure. Timepoint: Before surgery and one month after surgery. Method of measurement: Anal manometer. Ahvaz University of Medical Sciences Approved 2017-08-28 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)