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IRCT2014010816142N1 IRCT 2014-02-03 Vice chancellor for Research Shahid Beheshti University Medical Scieneces The effect of double nappy technique on acute complications of urethroplasty A Comparative study on Effect of two Types of Urine drainage cares (Open/closed system) on acute complications after Hypospadias repair in 6-36 months old children 2010-12-26 anticipated 108 Complete https://irct.ir/trial/15198 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 1 Hypospadias. Intervention 1: Intervention group with open urine drainage care (double nappy care method) after-surgery, the following procedure has been used: 1-In the central area of the first diaper a 3 by 3 cm two intersecting lines has been marked and cut. With a scissor two diagonal lines will be cut providing 4 triangles 2- 8 adhesive tapes (8cm in length by 1.5 cm in width) are needed 3- Fold one of the triangles inwardly and fix it with tape 4- The same procedure should be applied to the rest of three triangles. Cover lines between triangle with tape In order to avoid any contact with surgical site . 5- Lubricate around the hole in order to minimize the contact with surgical area. 6- Diapering should be done in such a way that the hole be in the front. 7-The tip of the stent carefully passes through the hole in the nappy. 8-First diaper should be fixed on child body by applying tapes. 9-Then, the second diaper with a larger size has been used. The free end of stent catheter has been positioned carefully and kinking, twisting or blocking were extremely avoided. 10- The inner diaper should be changed right after each defecation. The outer one should be changed upon contamination or wetting. There was no need to restrict child's movement and mother could hang the child. Mother learned how to change and weight the diaper. Evaluation indicators should be recorded after surgery through accurate observations.for 7 days and each 3 hrs (the dried diapers were weighted and again after getting wet and urine output measured and recorded). Intervention 2: Control group, with close urine drainage care after surgery the following procedure has been used : the dripping stent has been attached to a urine bag and it was fixed by hanger bar on railing's bed. The stent catheter was fixed on lower abdomen by adhesive tape . It should be noted that kinking, twisting or blocking of the dripping stent must be avoided. The child was place on the bed cradle and immobilized with arm or leg joints restraints . Mother learned how to care the catheter . Evaluation indicators should be recorded after surgery through accurate observations.for 7 days and each 3 hrs .
public Marzieh Fatemian
Mofid Chidlren's Hospital , Mirdamad ST, Shariati AVe
Tehran Iran (Islamic Republic of) +98 21 2290 9575 fatemian.marzieh@gmail.com fatemian_marzieh@yahoo.com shahid Beheshti University of Medical Sciences scientific Fatemeh Alaee karahroudy
Faculty in Nursing and Midwifery , Niyayesh Highway , Valiasr Ave
Tehran Iran (Islamic Republic of) +98 21 8865 5372 fatemeha@sbmu.ac.irfalaee@yahoo.com Shahid Beheshti University Of Medical Sciences Iran (Islamic Republic of) Criteria for inclusion: Being diagnosed with mid-shaft and distal hypospadias; Age between 6-36 months; Underwent the TIP procedure (Tubularized Incised Plate Urethroplasty); Parental consent Criteria for exclusion: Age below 6 month or older than 36 month; other than TIP procedure; Being diagnosed with hypospadias other than mid-shaft and distal; Accompanied by other diseases (Kidney disease, Diabetes Mellitus, coagulation defects, immune deficiency); Parents did not consent no limit 3 years Male Q54.1 Hypospadias, penile Prevention Prevention Intervention group with open urine drainage care (double nappy care method) after-surgery, the following procedure has been used: 1-In the central area of the first diaper a 3 by 3 cm two intersecting lines has been marked and cut. With a scissor two diagonal lines will be cut providing 4 triangles 2- 8 adhesive tapes (8cm in length by 1.5 cm in width) are needed 3- Fold one of the triangles inwardly and fix it with tape 4- The same procedure should be applied to the rest of three triangles. Cover lines between triangle with tape In order to avoid any contact with surgical site . 5- Lubricate around the hole in order to minimize the contact with surgical area. 6- Diapering should be done in such a way that the hole be in the front. 7-The tip of the stent carefully passes through the hole in the nappy. 8-First diaper should be fixed on child body by applying tapes. 9-Then, the second diaper with a larger size has been used. The free end of stent catheter has been positioned carefully and kinking, twisting or blocking were extremely avoided. 10- The inner diaper should be changed right after each defecation. The outer one should be changed upon contamination or wetting. There was no need to restrict child's movement and mother could hang the child. Mother learned how to change and weight the diaper. Evaluation indicators should be recorded after surgery through accurate observations.for 7 days and each 3 hrs (the dried diapers were weighted and again after getting wet and urine output measured and recorded). Control group, with close urine drainage care after surgery the following procedure has been used : the dripping stent has been attached to a urine bag and it was fixed by hanger bar on railing's bed. The stent catheter was fixed on lower abdomen by adhesive tape . It should be noted that kinking, twisting or blocking of the dripping stent must be avoided. The child was place on the bed cradle and immobilized with arm or leg joints restraints . Mother learned how to care the catheter . Evaluation indicators should be recorded after surgery through accurate observations.for 7 days and each 3 hrs . Removal of catheter by patient. Timepoint: every 3h for 7 days. Method of measurement: observations are recorded in patient’s information sheet. Level of child restlessness. Timepoint: every 3h for 7 days. Method of measurement: determined by amount of analgesics received and recorded patient’s information sheet. Catheter irrigation if needed. Timepoint: if needed. Method of measurement: observed and recorded in patient’s information sheet. Patency of the new urethra. Timepoint: every 3h for 7 days. Method of measurement: observations are recorded in patient’s information sheet. Urine volume over 24h. Timepoint: every 3h for 7 days. Method of measurement: observations are recorded in patient’s information sheet. Urinary tract infection. Timepoint: befor surgery and after removal of catheter. Method of measurement: urine calture and recorded in patient’s information sheet. Wound dehiscence. Timepoint: daily for 7 days. Method of measurement: observed and recorded in patient’s information sheet. Edima and bleeding in surgical site. Timepoint: every 3h for 7 days. Method of measurement: observed and recorded in patient’s information sheet. Wound infection in surgical site. Timepoint: daily for 7 days. Method of measurement: observed and recorded in patient’s information sheet. Strictures. Timepoint: at the time of catheter removal, one month, three month, six month after surgery. Method of measurement: observations are recorded in patient’s information sheet. Fistulas. Timepoint: at the time of catheter removal one month, three month, six month after surgery. Method of measurement: observations are recorded in patient’s information sheet. Vice chancellor for Research Shahid Beheshti University Medical Scieneces Approved 2010-10-31 Vice chancellor for Research Shahid Beheshti University of Medical sciences Chamran Highway - Evin Tehran Iran (Islamic Republic of)