Journal of pediatric surgery · 2017
The role of 2-octyl cyanoacrylate in prevention of penile adhesions after circumcision: A prospective, randomized trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Alemayehu Hanna, Sharp Nicole E, Gonzalez Katherine, Poola Ashwini S, Snyder Charles L, St Peter Shawn D
Аннотация
PURPOSE: Penile adhesions are the most common complication after circumcision, although strategies to decrease them are poorly studied. We conducted a prospective, randomized trial comparing the use of 2-octyl cyanoacrylate (glue) skin adhesive to hydrophobic ointment after circumcision.
METHODS: Patients <7years old undergoing circumcision were randomized to glue around the sutures and corona of the penis or antibiotic ointment. The primary outcome variable was postoperative penile adhesions. Utilizing a power of 0.8 and an alpha of 0.05, 168 patients were calculated for each arm. Because of high attrition, we planned to include up to 500 patients. Presence/absence of adhesions was evaluated 2-4weeks postop. Parents subjectively scored happiness, comfort, distress, and concern on a Likert scale 1-5.
RESULTS: From 11/2012 through 7/2016, 409 patients were enrolled. Adhesion data were available on 243 patients. There was no difference between glue (16.8%) and those with antibiotic ointment (15.2%) (p=0.88) or in parental satisfaction across all areas measured. 165 patients were lost to follow-up, evenly distributed between the two groups (38% vs. 42%, p=0.49).
CONCLUSION: The placement of 2-octyl cyanoacrylate skin adhesive does not decrease the rate of postoperative penile adhesions after circumcision. Parent satisfaction outcomes are similar.
TYPE OF STUDY: Treatment study.
LEVEL OF EVIDENCE: Level II.
METHODS: Patients <7years old undergoing circumcision were randomized to glue around the sutures and corona of the penis or antibiotic ointment. The primary outcome variable was postoperative penile adhesions. Utilizing a power of 0.8 and an alpha of 0.05, 168 patients were calculated for each arm. Because of high attrition, we planned to include up to 500 patients. Presence/absence of adhesions was evaluated 2-4weeks postop. Parents subjectively scored happiness, comfort, distress, and concern on a Likert scale 1-5.
RESULTS: From 11/2012 through 7/2016, 409 patients were enrolled. Adhesion data were available on 243 patients. There was no difference between glue (16.8%) and those with antibiotic ointment (15.2%) (p=0.88) or in parental satisfaction across all areas measured. 165 patients were lost to follow-up, evenly distributed between the two groups (38% vs. 42%, p=0.49).
CONCLUSION: The placement of 2-octyl cyanoacrylate skin adhesive does not decrease the rate of postoperative penile adhesions after circumcision. Parent satisfaction outcomes are similar.
TYPE OF STUDY: Treatment study.
LEVEL OF EVIDENCE: Level II.