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IRCT20110522006552N3 IRCT 2024-01-23 Shahid Beheshti University of Medical Sciences the outcome of fronto-orbital advancement in patients with non-syndromic anterior plagiocephaly Evaluation of esthetic and anthropometric outcomes of frontorbital correction for non-syndromic anterior plagiocephaly by modified z technique of temporal region osteotomy in 15khordad and Mofid hospitals during 2022-2024 2024-01-21 anticipated 49 Complete https://irct.ir/trial/73008 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Blinding description: In this study, the parents of the patients were informed about the type of technique used in the operation, because the surgical technique is different only during the operation, and after the surgery is completed and the suture is applied, the size and shape of the incision is similar to the routine surgery, and only the surgeon is aware of the nature of the procedure. The surgery is informed. The outcome assessors did not know about the technique used in the operation in presenting their opinions about the efficiency of the operation result. In post-operative visits, the surgeon did not know the type of technique to present his opinion on the result of each patient's operation. N/A Patients with Non- syndromic anterior plagiocephaly. Intervention group: For all patients with non-syndromic plagiocephaly, a coronal incision is first given so that the frontal bone can be moved after the flap is raised and turned down to 5 cm above the rim of the orbit, the flap is raised subperiosteally to the edge of the rim so that the supraorbital and supratrochlear nerves are not damaged. After correcting the shape of the skull and forehead on the head with a suitable design, the osteotomy of the upper region of the orbit and its continuation to the temporal region is performed as a z-osteotomy. Bone incisions and breaking the bone in the form of (Barrel Stave) are performed to correct the narrowing of the frontal area and the deformities in the frontal bone parts above the orbit and the upper part of the frontal bone separately. The repositioning of the upper parts of the eyeball is done as an approximation, and absorbable screws and plates are used to fix the bone parts. In temporal osteotomy, the 2 edges of the bone site are placed together in a z-shape so that there is less defect and no need for bone graft, and there is no possibility of the bone piece sliding or returning after fixing. After fixing the bone with screws and plates and reaching the desired shape, and sufficient hemostasis and drain placement, then the scalp flap is returned to its place, and its layers are repaired.. Yes - There is a plan to make this available What will be shared: All demographic data and primary and secondary outcome information after de-identification of shareable subjects When: The access period starts 6 months after the results are published To whom: Data and other documentation will be available to researchers working in academic and scientific institutions Conditions: After publishing the results in the form of an article, the data will be available for researchers to design the study by providing a logical reason to the correspondence author with the condition of maintaining ethical principles. Also, the data will be available if requested by the ethics committee of the university to evaluate the accuracy of the results. Where to obtain: Applicants can refer to Dr. Mehran Nouri, Assistant Specialist in Plastic Surgery, Shahid Beheshti University of Medical Sciences, to receive the required documents and data. Address: Tehran, Karim Khan Zand St., at the beginning of Shahid Dr. Azdi St. Postal code 1598764514 Email: mehrannoori64@yahoo.com Phone: 09122025141 How to obtain: Applicants must follow the protocols and procedures according to Shahid Beheshti University of Medical Sciences rules to access the desired files Comments:
public Mehran Noori
Tehran - Shahid Chamran Highway, Yemen Street - Shahid Arabi Street, next to Ayatollah Taleghani Hospital
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9982 mehrannoori64@yahoo.com Shahid Beheshti University of Medical Sciences scientific Seyed Esmail Hassanpour
15 Khordad Medical, Educational and Therapeutic Center, Dr. Azdi St. (first of Aban South), Karim Khan Zand St. Tehran, Iran
Tehran Iran (Islamic Republic of) 1598764514 +98 21 8894 3434 Hassanpour1394@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Written informed consent to undergo the surgical procedure Patients with anterior plagiocephaly were referred to the clinic in 15 Khordad and Mofid hospitals in Tehran between 2021 and 2023. According to the opinion of the plastic surgeon, patients with craniosynostosis who are candidates for correction with front orbital advancement. 3 months 24 months Both Multi- suture craniosynostosis Syndromic craniosynostosis Q67.3 Congenital malformations and deformations of the musculoskeletal system Treatment - Surgery Intervention group: For all patients with non-syndromic plagiocephaly, a coronal incision is first given so that the frontal bone can be moved after the flap is raised and turned down to 5 cm above the rim of the orbit, the flap is raised subperiosteally to the edge of the rim so that the supraorbital and supratrochlear nerves are not damaged. After correcting the shape of the skull and forehead on the head with a suitable design, the osteotomy of the upper region of the orbit and its continuation to the temporal region is performed as a z-osteotomy. Bone incisions and breaking the bone in the form of (Barrel Stave) are performed to correct the narrowing of the frontal area and the deformities in the frontal bone parts above the orbit and the upper part of the frontal bone separately. The repositioning of the upper parts of the eyeball is done as an approximation, and absorbable screws and plates are used to fix the bone parts. In temporal osteotomy, the 2 edges of the bone site are placed together in a z-shape so that there is less defect and no need for bone graft, and there is no possibility of the bone piece sliding or returning after fixing. After fixing the bone with screws and plates and reaching the desired shape, and sufficient hemostasis and drain placement, then the scalp flap is returned to its place, and its layers are repaired. Surgical and aesthetic satisfaction score. Timepoint: Before surgery and 3 months after intervention (surgery). Method of measurement: Satisfaction level questionnaire. Anthropometric skull measurements. Timepoint: Before surgery and 6 months after intervention (surgery). Method of measurement: Using a graduated ruler. Recurrence of deformity after surgery. Timepoint: 12 month after intervention. Method of measurement: Physical Examination. Shahid Beheshti University of Medical Sciences Approved 2023-06-27 Ethics Committee of shahid Beheshti University of Medical Sciences Floor 13, Block A, Ministry of Health& Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)