| 21. |
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| 22. |
- Carlander, Johan, 1971-
(författare)
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Energy based surgical instruments : With particular focus on collateral thermal injury
- 2015
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Iatrogenic post-operative nerve dysfunction is a significant problem in many areas of surgery and can be caused by collateral thermal injury from activation of energy based surgical devices (EBD).The aims of this thesis were to: create an animal model in order to compare mono- and bipolar electrosurgery (ES) and an ultrasonic dissection (UD) with regard to collateral thermal nerve injury, and with data of a national multicenter register to study the use of EBD and their potential effects on operation time and complication rates in thyroid surgery.urgical devices (EBD).Material and Methods: The biceps femoris muscle of 104 anesthetized rats was cut in a standard manner adjacent to the sciatic nerve using clinical relevant settings of mono- and bipolar ES and UD. The sciatic nerve was stimulated supramaximally and the electromyographic (EMG) potential recorded before and after each experiment. Nerve dysfunction was defined as > 10% reduction of the evoked EMG potential. In Paper II and III temperature was measured before, during and after instrument activation. The sciatic nerves were coded and examined blinded with light (LM) and electron microscopy (EM). Advanced temperature measurements were conducted in Paper II and III. In Paper IV, the use of EBD was specifically registered in the Scandinavian Quality Register for Thyroid, Parathyroid and Adrenal Surgery (SQRTPA) during one year and 1297 patients were included. Operation time, recurrent laryngeal nerve (RLN) injury, post-operative hypoparathyroidism and the use of topical haemostatic agents were compared between bipolar ES, electric vessel sealing (EVS) and UD. Clamp and Tie technique (C-A-T) being without thermal risk constituted the control group.Results: In Paper I the EMG potential was significantly more frequent reduced in the monopolar and bipolar ES group compared to the UD group and LM showed significantly less nerve damage in the UD group. In Paper II exact temperature measurements was possible with thermoelectric micros sensors and the thermal dose was significantly less and with less variation for the UD compared to the bipolar ES. Similar to the Paper I the EMG potential was significantly more frequent reduced in the ES group. Moderate and severe morphological damage was significantly less common in the UD group compared to monopolar ES. We found no statistical correlation between the highest temperatures/doses and the degree of morphological damage or functional loss. In Paper III the temperature increase was significantly less and with shorter duration in the UD group, compared to bipolar ES. LM and EM demonstrated loss of density in the myelin sheet only in a small number of nerves in all groups after instrument activation 1 mm from the nerve.In Paper IV, operation time was significantly shorter in the UD group and significantly longer in the EVS and bipolar ES group, compared to C-A-T. Postoperative hypoparathyroidism with need for Calcium treatment at discharge and at 6 weeks was significantly higher with ES instruments compared to UD. The incidence of reported RLN injury was 2.5% at 6 weeks postoperatively without statistical differences between the groups. Topical haemostatic agents were more frequently used in the EBD groups compared to C-A-T.Conclusion: The experimental Papers (I-III) demonstrated a lower risk of adverse collateral thermal nerve injury with activation of the mechanical UD technique compared to ES techniques. In the nationwide multicenter register Paper (IV), the use of UD shortened end EVS increased operation time compared to the low cost C-A-T. The UD instruments had a lower risk of hypoparathyroidism than electrosurgery.
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| 23. |
- Carlander, Johan, et al.
(författare)
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Risk of Complications with Energy-Based Surgical Devices in Thyroid Surgery : A National Multicenter Register Study
- 2016
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Ingår i: World Journal of Surgery. - : Springer Science and Business Media LLC. - 0364-2313 .- 1432-2323. ; 40:1, s. 117-123
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundEnergy-based surgical devices (EBD) combining cutting and coagulation are increasingly used in thyroid surgery. However, there is a lack of information about potential benefits and risk of complications outside controlled trials. The aims of this national multicenter register study were to describe the use of EDB, their potential effect on complication rates, and on operation time.Materials and methodsThe Scandinavian Quality Register for Thyroid and Parathyroid surgery includes 35 surgical units in Sweden and covered 88 % of the thyroid procedures performed during 2008–2009. The use of the EBD was specifically registered for 12 months, and 1297 patients were included. Surgically related complications and operation time were evaluated. The clamp-and-tie group (C-A-T) constituted the control group for comparison with procedures where EBD was used.ResultsThe thyroid procedures performed included C-A-T (16.6 %), bipolar electrosurgery (ES: 56.5 %), electronic vessel sealing (EVS: 12.2 %), and ultrasonic dissection (UD: 14.5 %). Mean operative time was longer with EVS (p < 0.001) and shorter with UD (p < 0.05) than in the other groups. The bipolar ES group and the EVS group had higher incidence of calcium treatment at discharge and after 6 weeks than the UD group. No significant difference in nerve injury was found between the groups. There was a significant more frequent use of topical hemostatic agents in the EBD group compared to C-A-T.ConclusionIn this national multicenter study, the use of UD shortened and EVS increased operating time. There was a higher risk of calcium treatment at discharge and after 6 weeks after use of EVS and bipolar ES than after UD use. There was a significant more frequent use of topical hemostatic agents in the EBD groups compared to C-A-T.
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| 24. |
- Celebioglu, F., et al.
(författare)
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Sentinel node biopsy in non-palpable breast cancer and in patients with a previous diagnostic excision
- 2007
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Ingår i: European Journal of Surgical Oncology. - : Elsevier BV. - 0748-7983 .- 1532-2157. ; 33:3, s. 276-280
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Tidskriftsartikel (refereegranskat)abstract
- Aim: As a means of staging the axilla with minimal surgical trauma, sentinel lymph node biopsy (SNB) has dramatically altered the management of early-stage breast cancer. The aim of this prospective multicentre study was to assess the safety of the method in cases of non-palpable tumours and in cases with an open biopsy prior to SNB. Method: In the period 1999-2001, 57 non-palpable breast cancers and 75 patients with diagnostic biopsy were collected prospectively to the first part of the study. In the second part, 745 patients with non-palpable breast cancers and 86 cases with prior open surgery diagnosed between 2000 and 2005 were followed up till the end of 2005. All patients in the first part of the study had an axillary clearance irrespective of sentinel node status, whereas in the second part axillary clearance was done only if the sentinel node was metastatic. Results: The detection rate was 95% in the group of non-palpable breast cancers, with a false negative rate of 5.6% (1/18), and the corresponding figures for the group with prior intervention were 96% and 10% (2/20). Two axillary recurrences, after a negative SNB at primary surgery, were found in the non-palpable group after 16 and 17 months, respectively. No axillary recurrence has been observed in the group of cancers with a prior open biopsy. Four women in the non-palpable group and two women with a diagnostic operation experienced distant metastases. Conclusion: We conclude that SNB is a safe procedure for women with non-palpable breast cancer, as well as after previous open diagnostic excision.
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| 25. |
- Dahlberg, Leif, et al.
(författare)
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Starkt samband övervikt/obesitas och ortopediska åkommor. Fetmaepidemins konsekvenser vidgas.
- 2008
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Ingår i: Läkartidningen. - 0023-7205. ; 105:34, s. 2246-2248
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Tidskriftsartikel (refereegranskat)abstract
- t is well known that overweight/obesity are risk factors for several important conditions of internal medicine. The positive correlation between gonarthrosis and a high BMI is also well investigated. However, the possible correlation between owerweight/obesitas and other orthopaedic conditions are less well studied and are therefore rarely discussed in either medical terms or economical considerations. Objective: To examine the relationship between owerweight/obesity and orthopaedic conditions. Patient BMI was compared with a reference population BMI in two assessments. In one we investigated patients who were diagnosed with ankle fracture in the emergency room (n=79). In the other we investigated outpatients with various orthopaedic conditions (n=647). In both assessments patients were recruited in a consecutive mode. The BMI of the patients with ankle fracture was self reported as were the BMI of the normal population. The outpatients were weighted and measured. Patients with ankle fractures differed significantly from the reference population, (1.92 units (p<0.001). The fracture odds ratio of BMI>30 was 3.46 (p<0.001). Similarly, the outpatients had 1.44 higher BMI units than the references (p<0,001). Odds ratio to become an orthopaedic outpatient if BMI>30 was 2.3 (p<0.001). In both investigations results were age and gender standardised. Both studies indicate that there is a positive correlation between BMI and the risk of sustaining orthopaedic conditions. Although there may be reporting-bias, results seem prominent enough to conclude that orthopaedic conditions may be added to other medical disciplines regarding negative consequences of overweight/obesity and strengthens the need for preventive measures aimed at the epidemic progress of overweight/obesity.
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| 26. |
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| 27. |
- de Boniface, J., et al.
(författare)
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Breast-conserving surgery followed by whole-breast irradiation offers survival benefits over mastectomy without irradiation
- 2018
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Ingår i: British Journal of Surgery. - : WILEY. - 0007-1323 .- 1365-2168. ; 105:12, s. 1607-1614
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Tidskriftsartikel (refereegranskat)abstract
- Background: The prognostic equivalence between mastectomy and breast-conserving surgery (BCS) followed by radiotherapy was shown in pivotal trials conducted decades ago. Since then, detection and treatment of breast cancer have improved substantially and recent retrospective analyses point towards a survival benefit for less extensive breast surgery. Evidence for the association of such survival data with locoregional recurrence rates is largely lacking.Methods: The Swedish Multicentre Cohort Study prospectively included clinically node-negative patients with breast cancer who had planned sentinel node biopsy between 2000 and 2004. Axillary lymph node dissection was undertaken only in patients with sentinel node metastases. For the present investigation, adjusted survival analyses were used to compare patients who underwent BCS and postoperative radiotherapy with those who received mastectomy without radiotherapy.Results: Of 3518 patients in the Swedish Multicentre Cohort Study, 2767 were included in the present analysis; 2338 had BCS with postoperative radiotherapy and 429 had mastectomy without radiotherapy. Median follow-up was 156 months. BCS followed by whole-breast irradiation was superior to mastectomy without irradiation in terms of both overall survival (79.5 versus 64.3 per cent respectively at 13 years; P < 0.001) and breast cancer-specific survival (90.5 versus 84.0 per cent at 13 years; P < 0.001). The local recurrence rate did not differ between the two groups. The axillary recurrence-free survival rate at 13 years was significantly lower after mastectomy without irradiation (98.3 versus 96.2 per cent; P < 0.001).Conclusion: The present data support the superiority or BCS with postoperative radiotherapy over mastectomy without radiotherapy. The axillary recurrence rate differed significantly, and could be one contributing factor in a complex explanatory model.
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| 28. |
- de Boniface, Jana, 1971-
(författare)
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Sentinel Node Biopsy in Breast Cancer : Clinical and Immunological Aspects
- 2007
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The most important prognostic factor in breast cancer is the axillary lymph node status. The sentinel node biopsy (SNB) is reported to stage the axilla with an accuracy > 95 % in early breast cancer. Tumour-related perturbation of T-cell function has been observed in patients with malignancies, including breast cancer. The down-regulation of the important T-cell activation molecules CD3-ζ and CD28 may cause T-cell dysfunction, anergy, tolerance and deletion.The expression of CD3-ζ and CD28 was evaluated in 25 sentinel node biopsies. The most pronounced down-regulation was seen in the paracortical area, where the best agreement between both parameters was observed. CD28 expression was significantly more suppressed in CD4+ than in CD8+ T-cells.From the Swedish sentinel node database, 109 patients with breast cancer > 3 cm planned for both SNB and a subsequent axillary dissection were identified. The false negative rate (FNR) was 12.5%. Thirteen cases of tumour multifocality were detected on postoperative pathology. The FNR in this subgroup was higher (30.8%) than in patients with unifocal disease (7.8%; P = 0.012).From the Swedish SNB multicentre cohort trial, 2246 sentinel node-negative patients who had not undergone further axillary surgery were selected for analysis. After a median follow-up time of 37 months (range 0-75), 13 isolated axillary recurrences (13/2246; 0.6%) were found. In another 14 cases, local or distant failure preceded or coincided with axillary relapse (27/2246; 1.2%). In conclusion, the immunological analysis of the sentinel node might provide valuable prognostic information and aid selection of patients for immunotherapy. SNB is encouraged in breast cancer larger than 3 cm, if no multifocal growth pattern is present. The axillary recurrence rate after a negative SNB in Sweden is in accordance with international figures. However, a longer follow-up is mandatory before the true failure rate of the SNB can be determined.
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| 29. |
- de Boniface, J., et al.
(författare)
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Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial
- 2017
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Ingår i: BMC Cancer. - : Springer Science and Business Media LLC. - 1471-2407. ; 17
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Tidskriftsartikel (refereegranskat)abstract
- Background: The role of axillary lymph node dissection (ALND) has increasingly been called into question among patients with positive sentinel lymph nodes. Two recent trials have failed to show a survival difference in sentinel node-positive breast cancer patients who were randomized either to undergo completion ALND or not. Neither of the trials, however, included breast cancer patients undergoing mastectomy or those with tumors larger than 5 cm, and power was debatable to show a small survival difference. Methods: The prospective randomized SENOMAC trial includes clinically node-negative breast cancer patients with up to two macrometastases in their sentinel lymph node biopsy. Patients with T1-T3 tumors are eligible as well as patients prior to systemic neoadjuvant therapy. Both breast-conserving surgery and mastectomy, with or without breast reconstruction, are eligible interventions. Patients are randomized 1: 1 to either undergo completion ALND or not by a web-based randomization tool. This trial is designed as a non-inferiority study with breast cancer-specific survival at 5 years as the primary endpoint. Target accrual is 3500 patients to achieve 80% power in being able to detect a potential 2.5% deterioration of the breast cancer-specific 5-year survival rate. Follow-up is by annual clinical examination and mammography during 5 years, and additional controls after 10 and 15 years. Secondary endpoints such as arm morbidity and health-related quality of life are measured by questionnaires at 1, 3 and 5 years. Discussion: Several large subgroups of breast cancer patients, such as patients undergoing mastectomy or those with larger tumors, have not been included in key trials; however, the use of ALND is being questioned even in these groups without the support of high-quality evidence. Therefore, the SENOMAC Trial will investigate the need of completion ALND in case of limited spread to the sentinel lymph nodes not only in patients undergoing any breast surgery, but also in neoadjuvantly treated patients and patients with larger tumors.
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| 30. |
- de Boniface, J., et al.
(författare)
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The generalisability of randomised clinical trials: an interim external validity analysis of the ongoing SENOMAC trial in sentinel lymph node-positive breast cancer
- 2020
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Ingår i: Breast Cancer Research and Treatment. - : Springer Science and Business Media LLC. - 0167-6806 .- 1573-7217. ; 180:1, s. 167-176
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Tidskriftsartikel (refereegranskat)abstract
- Purpose None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC). Methods In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years. Results Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time. Conclusions This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials. Trial registration: NCT 02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015
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