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- Semb, Gunvor, et al.
(författare)
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A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management.
- 2017
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Ingår i: Journal of Plastic Surgery and Hand Surgery. - : Taylor & Francis. - 2000-656X .- 2000-6764. ; 51:1, s. 2-13
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND AIMS: Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project.METHOD: Ten established national or regional cleft centres participated. Lip and soft palate closure at 3-4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3-4 months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palate closure at 3-4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes.RESULTS: Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention at 5 years.CONCLUSION: The series of reports that follow this introductory paper include comparisons at age 5 of surgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parental satisfaction. The outcomes recorded and the numbers analysed for each outcome and time point are described in the series.TRIAL REGISTRATION: ISRCTN29932826.
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| 2. |
- Bannister, P., et al.
(författare)
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Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 3. Descriptive study of postoperative nursing care following first stage cleft closure
- 2017
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Ingår i: Journal of Plastic Surgery and Hand Surgery. - : Taylor & Francis. - 2000-656X .- 2000-6764. ; 51:1, s. 21-26
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Tidskriftsartikel (refereegranskat)abstract
- Background: Cleft lip and palate is one of the most common congenital anomalies requiring surgical treatment in children, normally commenced in the first year of life. Following the initiation of a group of multicentre surgical trials of primary surgery, variations in postoperative recovery and management became apparent. An agreement was made for a nurse-led survey in eight surgical centres to document postoperative care and recovery. Materials and methods: A postoperative recovery clinical report form was developed to capture relevant data for the children participating in the four arms of the trials. This included the age and weight at admission, the postoperative recovery setting, pain management, postoperative feeding, post-operative complications, and length of hospital stay. Results: Four hundred and three nursing forms from the first surgical procedure were returned for analysis. Differences in important aspects of care such as postoperative analgesia and postoperative feeding were evident. Postoperative care was influenced by local custom and practice, as little firm clinical evidence exists to guide optimal management. Conclusion: Postoperative recovery may play a significant role in the future selection of surgical protocols, and future trials need to consider cross-study site training to familiarise nurses, prior to any changes in surgical methods.
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| 3. |
- Kölby, David, 1993, et al.
(författare)
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Craniotomy of the Fused Sagittal Suture Over the Superior Sagittal Sinus Is a Safe Procedure
- 2017
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Ingår i: Journal of Craniofacial Surgery. - : Ovid Technologies (Wolters Kluwer Health). - 1049-2275. ; 28:3, s. 666-669
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Spring-assisted cranioplasty to correct sagittal synostosis is based on midline craniotomy through the closed sagittal suture, over the superior sagittal sinus (SSS). The aim of the present study was to evaluate the perioperative safety of this technique. Materials and Methods: This is a retrospective study of all patients operated with median craniotomy and springs from 1998 to the end of 2015. For comparison, all Pi-plasties performed during the same time interval were also evaluated. The safety measures were evaluated based on incidence of damage to SSS, incidence of dural tears, perioperative blood loss, operative time, and hospital stay. Results: In the group that had undergone midline craniotomy combined with springs (n = 225), 4 perioperative damages to SSS and 1 dural tear were seen. The perioperative blood loss was 62.8 +/- 65.3mL (mean +/- standard deviation). The operative time was 67.9 +/- 21.5 minutes and the hospital stay was 4.8 +/- 1.1 days. In the group that had undergone pi-plasty (n = 105), no damages to SSS but 3 dural tears were seen. The perioperative blood loss was 352.8 +/- 174.4 mL. The operative time was 126.0 +/- 31.7 minutes and the hospital stay was 7.1 +/- 1.4 days. Conclusion: Craniotomy SSS in sagittal synostosis is a safe procedure with low morbidity in terms of damage to the SSS. Midline craniotomy combined with springs has significantly lower preoperative blood loss, operative time, and hospital stay (P < 0.001 for all) compared to pi-plasty.
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