Hypothesis: The purpose of this study is to prove that delayed elective repair of inguinal hernias at a post conceptual age of 55 weeks in the premature infant has a significantly lower morbidity and mortality than repair prior to discharge from the hospital.
Specific Aims : 1. Determine if delayed repair of inguinal hernias in the premature infant has a significantly lower morbidity and mortality than repair prior to discharge with the specific aims as follows: a) To show a decreased mortality in the delayed group, b) To show that there are fewer episodes of post operative apnea and bradycardia in delayed group, c) To show that the post operative complications, such as testicular atrophy, due to decreased technical difficulty in the delayed group, are decreased (larger infant therefore less technically demanding surgery), and d) To show no significant increase in rate of incarceration in the delayed group. Methods: This is a prospective, randomized study. Premature infants, who have inguinal hernia (s), hospitalized at participating centers will be recruited for the study. After entry criteria are met and explanation of the investigational nature of the study has been performed, an informed consent will be obtained from the patient's parent or legal guardian. Patient's parents/guardians and investigators will be informed of the treatment limb to which they are randomized. Immediate Treatment Limb: Elective hernia repair will be performed once the infant has recovered from other diseases of prematurity, is free of ventilatory support, and is ready for discharge home. The following data will be recorded: the patient's EGA, post-conceptual age at time of repair, birth weight, weight at time of repair, pre-operative co-morbidities, operative time, anesthetics used intraoperatively, post-natal ventilator requirements, type of surgery, intraoperative complications, ventilator measurements intra and post-operatively, apneic/bradycardic events, ICU/hospital stay post operatively and follow-up information. Patients will be kept on the study until the endpoint of clearance at time of post-operative visit or death. Patients excluded from the study for social reasons will be followed as patients in the immediate treatment limb. Delayed Treatment Limb: Elective hernia repair will be performed once the infant has recovered from other diseases of prematurity, is free of ventilatory support, and has reached the post conceptual age of 55 weeks. Parents/Guardians will be educated as to signs of incarceration, importance of examination of hernia, as well as techniques of hernia reduction. The patients will be followed at monthly intervals by the pediatric surgical nurse clinician until the time of their repair. Data will be recorded in a manner identical to the immediate treatment limb with the addition of recording any ER visits related to hernia, ER reductions, emergent operations, and complications. Patients will be kept on the study until the endpoint of post-operative clearance at follow-up visit or death.
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