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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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- Hansson, Emma, 1981, et al.
(författare)
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Gothenburg Breast reconstruction (GoBreast) II protocol: a Swedish partially randomised patient preference, superiority trial comparing autologous and implant-based breast reconstruction.
- 2024
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Ingår i: BMJ open. - 2044-6055. ; 14:7
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Tidskriftsartikel (refereegranskat)abstract
- Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. Randomised controlled trials (RCTs) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The objective of this study is to compare implant-based and autologous breast reconstruction in non-irradiated patients. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction.The study design partially randomised patient preference trial might be a way to overcome the aforementioned challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose the method. The study is designed as a superiority trial based on the patient-reported questionnaire BREAST-Q and 124 participants will be randomised. In the preference cohort, patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60 months. Embedded qualitative studies and within-trial economic evaluation will be performed. The primary outcome is patient-reported breast-specific quality of life/satisfaction, and the secondary outcomes are complications, factors affecting satisfaction and cost-effectiveness.The study has been approved by the Swedish Ethical Review Authority (2023-04754-01). Results will be published in peer-reviewed scientific journals and presented at peer-reviewed scientific meetings.NCT06195865.
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3. |
- Jepsen, Christian, 1979, et al.
(författare)
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Normative BREAST-Q reconstruction scores for satisfaction and well-being of the breasts and potential donor sites: what are Swedish women of the general population satisfied/dissatisfied with?
- 2023
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Ingår i: Journal of plastic surgery and hand surgery. - 2000-6764. ; 58, s. 124-131
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Tidskriftsartikel (refereegranskat)abstract
- Normative data for interpreting the BREAST-Q reconstruction module are currently limited to four populations. The primary aim of this study was to create Swedish normative values for the BREAST-Q reconstruction domains. The secondary aim was to describe what aspects of the breasts and potential donor sites that women of the general population are generally satisfied or dissatisfied with.The BREAST-Q reconstruction module was sent to a random sample of 400 women currently living in Region Västra Götaland. Descriptive data are presented.One hundred and forty-six women answered the questionnaire (36.5%). The mean age of the cohort was 53 years, and the mean body mass index (BMI) was 25 kg/m2. Mean total scores ranged from 50 to 90. The mean score for satisfaction with breast was 57 on a 0-100 scale. Women with high BMI values seem to be less satisfied with their breasts and physical and sexual well-being. The participants were most satisfied with their breasts when clothed. Overall, the reported physical well-being related to potential donor sites was high.Normative data for BREAST-Q constitute a reference point, which allows us to put another perspective on changes in scores rather than just comparing scores before and after surgery. Scores were somewhat different than scores in previously published normative populations, which indicates that there might be cultural differences in breast satisfaction.
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4. |
- Löfstrand, Jonas, 1981, et al.
(författare)
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Long-term patient-reported back and shoulder function after delayed breast reconstruction with a latissimus dorsi flap: case-control cohort study.
- 2024
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Ingår i: The British journal of surgery. - 1365-2168. ; 111:1
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Tidskriftsartikel (refereegranskat)abstract
- Sacrifice of the latissimus dorsi (LD) muscle might entail donor site morbidity when used in delayed breast reconstruction. Previous studies are small, have short follow-up, and demonstrate diverging results. The aims of this study were to evaluate long-term patient-reported effects on shoulder and back function following LD flap harvest, and to investigate predictors for a worse outcome.This is a retrospective observational case-control cohort study. Cases were all patients who had undergone an LD flap reconstruction during the years 2007-2017. Controls were patients reconstructed with a deep inferior epigastric perforator (DIEP) flap during the same time period. Participants completed two validated questionnaires; the BREAST-Q reconstruction LD domains and the Western Ontario Shoulder Osteoarthritis Index (WOOS).A total of 135 cases (75 per cent) and 118 controls (60 per cent) responded to the questionnaires. The mean follow-up time was 7 years. Patients reconstructed with a LD flap were significantly less satisfied with their back and shoulder function when compared to the DIEP controls, as measured with BREAST-Q and WOOS. Predictors for a poor patient-reported back and shoulder function included axillary surgery and axillary radiotherapy, especially when combined, as well as higher age at reconstruction.Patients who have undergone LD flap for delayed breast reconstruction had a lower satisfaction with back and shoulder function, when compared to patients who had undergone a DIEP reconstruction. Delayed LD reconstruction should be used with care, especially in patients who have undergone axillary surgery and axillary radiotherapy.
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7. |
- 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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8. |
- Hansson, Emma, 1981, et al.
(författare)
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A systematic review of randomised controlled trials in breast reconstruction.
- 2024
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Ingår i: Journal of Plastic Surgery and Hand Surgery. - 2000-656X .- 2000-6764. ; 59, s. 53-64
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Tidskriftsartikel (refereegranskat)abstract
- For preference sensitive treatments, such as breast reconstructions, there are barriers to conducting randomised controlled trials (RCTs). The primary aims of this systematic review were to investigate what type of research questions are explored by RCTs in breast reconstruction, where have they been performed and where have they been published, and to thematise the research questions and thus create an overview of the state of the research field.Randomised controlled trials investigating any aspect of breast reconstructions were included. The PubMed database was searched with a pre-defined search string. Inclusion and data abstraction was performed in a pre-defined standardised fashion. For the purpose of this study, we defined key issues as comparison of categories of breast reconstruction and comparison of immediate and delayed breast reconstruction, when the thematisation was done.A total of 419 abstracts were retrieved from the search. Of the 419, 310 were excluded as they were not RCTs concerning some aspect of breast reconstruction, which left us with 110 abstracts to be included in the study. The research questions of the included studies could more or less be divided into seven different themes inclusive of 2 key issues: Other issues - comparison of different categories of breast reconstruction, comparison of immediate and delayed breast reconstruction, surgical details within a category of breast reconstruction, surgical details valid for several categories of breast reconstruction, donor site management, anaesthetics, and non-surgical details. Only five studies compared key issues, and they all illustrate the challenges with RCTs in breast reconstruction.A total of 110 publications based on RCTs in breast reconstruction have been published. Seven themes of research questions could be identified. Only five studies have explored the key issues. Better scientific evidence is needed for the key issues in breast reconstruction, for example by implementing a new study design in the field.
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9. |
- 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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10. |
- Löfstrand, Jonas, 1981, et al.
(författare)
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Comparison of patient-reported achievements of goals and core outcomes with delayed breast reconstruction in irradiated patients: latissimus dorsi with an implant versus DIEP.
- 2023
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Ingår i: Journal of plastic surgery and hand surgery. - 2000-6764. ; 58, s. 74-81
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Tidskriftsartikel (refereegranskat)abstract
- Different women's individual goals with a breast reconstruction vary, and few studies compare techniques in light of the different goals. This study aimed to compare patient-reported core outcomes in patients reconstructed with deep inferior epigastric artery perforator (DIEP) flaps and latissimus dorsi (LD) flaps. Second, breast-related factors that the patients were particularly satisfied/dissatisfied with were analyzed.This was a retrospective cross-sectional study, which includes women who had undergone mastectomy and radiation, followed by delayed breast reconstructions with either LD flap and implant or DIEP flap during 2007-2017. The patient-reported core outcomes of overall breast-specific quality of life, normality, women's cosmetic satisfaction, self-esteem, emotional well-being, and physical well-being were analyzed using BREAST-Q.The patients were divided into LD and implant (n = 135 patients) and DIEP (n = 118 patients) groups, and both were demographically similar. The median follow-up was 8 years. The DIEP group scored significantly higher than the LD and implant group in five out of six domains. A high satisfaction was reported in questions regarding the feeling or appearance when having clothes on, whereas the greatest dissatisfaction was reported regarding questions entailing symmetry and the appearance without clothes.After 7 years, patients' breast-specific quality of life, normality, women's cosmetic satisfaction, self-esteem, emotional well-being, and physical well-being seem to be higher in irradiated patients who have been reconstructed with DIEP flap as compared to patients reconstructed with LD flap and implant. In both groups, patient satisfaction is high regarding their appearance when clothed, whereas the lowest satisfaction scores were reported in situations without clothing.
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