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Sökning: WFRF:(Salehi Sahar)

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1.
  • Falconer, Henrik, et al. (författare)
  • Robot-assisted approach to cervical cancer (RACC) : An international multi-center, open-label randomized controlled trial
  • 2019
  • Ingår i: International Journal of Gynecological Cancer. - : Wiley-Blackwell. - 1048-891X .- 1525-1438. ; 29:6, s. 1072-1076
  • Tidskriftsartikel (refereegranskat)abstract
    • Background Radical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival. Primary Objective To investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy. Study Hypothesis Robot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes. Trial Design Prospective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden. Major Inclusion/Exclusion Criteria Women over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years. Primary Endpoint Recurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer. Sample Size The clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1-β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients. Estimated Dates for Completing Accrual and Presenting Results Trial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter. Trial Registration The trial is registered at ClinicalTrials.gov (NCT03719547).
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2.
  • Bollino, Michele, et al. (författare)
  • Pelvic sentinel lymph node biopsy in endometrial cancer- A simplified algorithm based on histology and lymphatic anatomy
  • 2020
  • Ingår i: International Journal of Gynecological Cancer. - : Wiley-Blackwell. - 1048-891X. ; 30:3, s. 339-345
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective: To achieve the full potential of sentinel lymph node (SLN) detection in endometrial cancer, both presumed low- A nd high-risk groups should be included. Perioperative resource use and complications should be minimized. Knowledge on distribution and common anatomical sites for metastatic SLNs may contribute to optimizing the concept while maintaining sensitivity. Proceeding from previous studies, simplified algorithms based on histology and lymphatic anatomy are proposed. Methods: Data on mapping rates and locations of pelvic SLNs (metastatic and non-metastatic) from two previous prospective SLN studies in women with endometrial cancer were retrieved. Cervically injected indocyanine green was used as a tracer and an ipsilateral re-injection was performed in case of non-display of the upper and/or lower paracervical pathways. A systematic surgical algorithm was followed with clearly defined SLNs depicted on an anatomical chart. In high-risk endometrial cancer patients, removal of SLNs was followed by a pelvic and para-aortic lymphadenectomy. Results: 423 study records were analyzed. The bilateral mapping rates of the upper and lower paracervical pathways were 88.9% and 39.7%, respectively. 72% of all SLNs were typically positioned along the upper paracervical pathway (interiliac and/or proximal obturator fossa) and 71 of 75 (94.6%) of pelvic node positive women had at least one metastatic SLN at either of these positions. Women with grade 1-2 endometroid cancers (n=275) had no isolated metastases along the lower paracervical pathway compared with two women with high-risk histologies (n=148). Conclusion: SLNs along the upper paracervical pathway should be identified in all endometrial cancer histological subtypes; removal of nodes at defined typical positions along the upper paracervical pathway may replace a site-specific lymphadenectomy in case of non-mapping despite tracer re-injection. Detection of SLNs along the lower paracervical pathway can be restricted to high-risk histologies and a full pre-sacral lymphadenectomy should be performed in case of non-display.
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3.
  • Hayden, Jane M., et al. (författare)
  • Intraperitoneal ropivacaine reduces time interval to initiation of chemotherapy after surgery for advanced ovarian cancer: randomised controlled double-blind pilot study.
  • 2020
  • Ingår i: British journal of anaesthesia. - 1471-6771. ; 124:5, s. 562-70
  • Tidskriftsartikel (refereegranskat)abstract
    • Advanced-stage ovarian cancer has a poor prognosis; surgical resection with the intent to leave no residual tumour followed by adjuvant chemotherapy is the standard treatment. Local anaesthetics (LA) have anti-inflammatory and analgesic effects. We hypothesised that intraperitoneal LA (IPLA) would lead to improved postoperative recovery, better pain relief, and earlier start of chemotherapy.This was a prospective, randomised, double-blind, placebo-controlled pilot study in 40 women undergoing open abdominal cytoreductive surgery. Patients were randomised to receive either intraperitoneal ropivacaine (Group IPLA) or saline (Group Placebo) perioperatively. Except for study drug, patients were treated similarly. Intraoperatively, ropivacaine 2 mg ml-1 or 0.9% saline was injected thrice intraperitoneally, and after operation via a catheter and analgesic pump into the peritoneal cavity for 72 h. Postoperative pain, time to recovery, home discharge, time to start of chemotherapy, and postoperative complications were recorded.No complications from LA administration were recorded. Pain intensity and rescue analgesic consumption were similar between groups. Time to initiation of chemotherapy was significantly shorter in Group IPLA (median 21 [inter-quartile range 21-29] vs 29 [inter-quartile range 21-40] days; P=0.021). Other parameters including time to home readiness, home discharge and incidence, and complexity of postoperative complications were similar between the groups.Intraperitoneal ropivacaine during and for 72 h after operation after cytoreductive surgery for ovarian cancer is safe and reduces the time interval to initiation of chemotherapy. Larger studies are warranted to confirm these initial findings.NCT02256228.
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4.
  • Persson, Jan, et al. (författare)
  • Pelvic Sentinel lymph node detection in High-Risk Endometrial Cancer (SHREC-trial)—the final step towards a paradigm shift in surgical staging
  • 2019
  • Ingår i: European Journal of Cancer. - : Elsevier. - 0959-8049. ; 116, s. 77-85
  • Tidskriftsartikel (refereegranskat)abstract
    • Study aims: To prospectively assess the diagnostic accuracy of a pelvic sentinel lymph node (SLN) algorithm in high-risk endometrial cancer (HREC). Patients and methods: Consecutive women with presumed FIGO stage I-II HREC underwent robotic surgery at two academic centres by five accredited surgeons. An anatomically based algorithm was adhered to, following cervical injection of indocyanine green (ICG), with reinjection of tracer in case of non-display of predefined lymphatic pathways. After removal of SLNs, a pelvic and infrarenal para-aortic lymphadenectomy was performed. Primary end-point was sensitivity of the SLN-ICG algorithm. Secondary end-points were sensitivity of the overall SLN algorithm (including macroscopically suspect nodes as SLNs), SLN mapping rates and morbidity of the SLN procedure. Results: Two hundred fifty-seven women were analysed; 54 had pelvic lymph node metastases (LNMs), and 52 of those were correctly identified by the SLN-ICG algorithm. In two women (one with false-negative ICG-SLNs and one non-mapped woman), the pelvic LNMs were identified by the overall SLN algorithm. The SLN-ICG algorithm had a sensitivity of 98% (95% confidence interval [CI] 89–100) and a negative predictive value of 99.5% (95% CI 97–100). The sensitivity of the overall SLN algorithm was 100% (95% CI 92–100) and the negative predictive value was 100% (95% CI 98–100). The bilateral mapping rate was 95%. Two women (1%) had isolated para-aortic metastases. No adverse events occurred during the SLN procedure. Conclusion: With a complete sensitivity to detect pelvic LNMs, the described pelvic SLN algorithm can, in the hands of experienced surgeons, exclude overall nodal involvement in 99% and thereby safely replace a full lymphadenectomy in HREC.
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5.
  • Salehi, Sahar, et al. (författare)
  • Cardiophrenic lymph node resection in advanced ovarian cancer : surgical outcomes, pre- and postoperative imaging
  • 2018
  • Ingår i: Acta Oncologica. - : Taylor & Francis. - 0284-186X. ; 57:6, s. 820-824
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective: To evaluate the accuracy of preoperative imaging in the diagnosis of cardiophrenic lymph node (CPLN) metastases and to report perioperative outcomes after resection of CPLN at the time of cytoreductive surgery for advanced epithelial ovarian cancer (EOC). Furthermore, to assess clearance of CPLN by postoperative imaging. Methods: All women with stage IIIC/IV EOC subjected to surgery at our institution from January 2014 to October 2016 were retrospectively identified from a database. Among these, women subjected to CPLN resection during surgery were identified. Pre- and postoperative computed tomography (CT) scans, pathology reports, surgical approach and outcomes were reviewed. Results: One hundred and eighty women with stage IIIC/IV EOC subjected to surgery with curative intent were identified. Twenty-four (13%) of these women underwent CPLN resection. All had CT imaging suggestive of CPLN metastases. 20/24 (83%) had confirmed metastases upon final pathology. CPLN resection was associated with longer operation time, more often advanced upper abdominal surgery and more postoperative complications but there was no difference in days from surgery to initiation of chemotherapy. Postoperative CT was still indicative of CPLN metastases in 13/22 (59%) women despite resection with confirmative pathology. Conclusions: Resection of CPLN metastases is highly feasible without considerable added morbidity. Concern regarding surgical clearance is raised since postoperative imaging was indicative of metastases in the majority of women. The prognostic significance of stage IV disease based exclusively on CPLN metastases is unclear and any survival benefit from the procedure is yet to be determined.
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6.
  • Salehi, Sahar, et al. (författare)
  • Long-term quality of life after comprehensive surgical staging of high-risk endometrial cancer - results from the RASHEC trial
  • 2018
  • Ingår i: Acta Oncologica. - : TAYLOR & FRANCIS LTD. - 0284-186X .- 1651-226X. ; 57:12, s. 1671-1676
  • Tidskriftsartikel (refereegranskat)abstract
    • Purpose: The health-related quality of life (HRQoL) outcomes after comprehensive surgical staging including infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer (EC) are unknown. Our aim was to investigate the long-term HRQoL between robot-assisted laparoscopic surgery (RALS) and laparotomy (LT). Patients and Methods: A total of 120 women with high-risk stage I-II EC were randomised to RALS or LT for hysterectomy, bilateral salpingoophorectomy, pelvic and infrarenal paraaortic lymphadenectomy in the previously reported Robot-Assisted Surgery for High-Risk Endometrial Cancer trial. The HRQoL was measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-30) and its supplementary questionnaire module for endometrial cancer (QLQ-EN24) questionnaire. Women were assessed before and 12 months after surgery. In addition, the EuroQol Eq5D non-disease specific questionnaire was used for descriptive analysis. Results: There was no difference in the functional scales (including global health status) in the intention to treat analysis, though LT conferred a small clinically important difference (CID) over RALS in cognitive functioning albeit not statistically significant -6 (95% CI-14 to 0, p = .06). LT conferred a significantly better outcome for the nausea and vomiting item though it did not reach a CID, 4 (95% CI 1 to 7, p = .01). In the EORTC-QLQ/QLQ-EN24, no significant differences were observed. Eq5D-3L questionnaire demonstrated a higher proportion of women reporting any extent of mobility impairment 12 months after surgery in the LT arm (p = .03). Conclusion: Overall, laparotomy and robot-assisted surgery conferred similar HRQoL 12 months after comprehensive staging for high-risk EC.
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7.
  • Salehi, Sahar, et al. (författare)
  • Lymphedema, serious adverse events, and imaging 1 year after comprehensive staging for endometrial cancer: results from the RASHEC trial
  • 2019
  • Ingår i: International Journal of Gynecological Cancer. - : LIPPINCOTT WILLIAMS & WILKINS. - 1048-891X .- 1525-1438. ; 29:1, s. 86-93
  • Tidskriftsartikel (refereegranskat)abstract
    • Background and Objectives In the Robot Assisted Surgery for High Risk Endometrial Cancer (RASHEC) trial, patients with high-risk endometrial cancer were randomly assigned to robot-assisted laparoscopic surgery (RALS) or laparotomy for pelvic and infrarenal para-aortic lymph node dissection. We here report on self-reported lower limb lymphedema (LLL), lymphocyst formation, ascites, and long-term serious adverse events 12 months after surgery. Patients and methods Patients were enrolled between 2013 and 2016, and 96 patients were included in the per protocol analysis, evenly distributed between RALS and laparotomy. Self-reported LLL was recorded using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for endometrial cancerEN24, assessed before and 12 months after surgery. Computed tomography was assessed at baseline, 3, and 12 months. Medical charts were reviewed for serious adverse events and hospital admissions 31 to 365 days after surgery. Results At 12 months after laparotomy and RALS, 61% and 50% patients, respectively, reported LLL (p = 0.31). In univariate analysis, the mean score of LLL at 12 months was significantly higher for laparotomy than for RALS (p amp;lt; 0.05) and for those without abdominal drainage (p = 0.02), but was not independently associated with LLL in the multivariate analysis. Imaging showed no significant difference in lymphocyst formation or ascites between surgical modalities. No difference was found in serious adverse events and admissions to hospital for any reason. There was no agreement between lymphocyst formation or ascites and self-reported LLL. Conclusion Follow-up 1 year after comprehensive surgical staging for high-risk endometrial cancer showed no differences in self-reported LLL, findings on imaging, or SAE between laparotomy and robot-assisted surgery.
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8.
  • Salehi, Sahar, et al. (författare)
  • Robot-assisted laparoscopy versus laparotomy for infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer: A randomised controlled trial
  • 2017
  • Ingår i: European Journal of Cancer. - : ELSEVIER SCI LTD. - 0959-8049 .- 1879-0852. ; 79, s. 81-89
  • Tidskriftsartikel (refereegranskat)abstract
    • Purpose: To investigate if robot-assisted laparoscopic surgery (RALS) was non-inferior to laparotomy (LT) in harvesting infrarenal paraaortic lymph nodes in patients with presumed stage IeII high-risk endometrial cancer. Patients and methods: Patients with histologically proven endometrial cancer, presumed stage IeII with high-risk tumour features, were randomised to hysterectomy, bilateral salpingo-oophorectomy, pelvic and paraaortic lymphadenectomy by either RALS or LT. Primary outcome was paraaortic lymph node count. Secondary outcomes were perioperative events, postoperative complications and total health care cost. Results: Overall 120 patients were randomised and 96 patients were included in the per protocol analysis. Demographic, clinical and tumour characteristics were evenly distributed between groups. Mean (+/- SD) paraaortic lymph node count was 20.9 (+/- 9.6) for RALS and 22 (+/- 11, p = 0.45) for LT. The difference of means was within the non-inferiority margin (-1.6, 95% CI -5.78, 2.57). Mean pelvic node count was lower after RALS (28 +/- 10 versus 22 +/- 8, p amp;lt; 0.001). There was no difference in perioperative complications or readmissions between the groups. Operation time was longer (p amp;lt; 0.001) but total blood loss less (amp;lt;0.001) and hospital stay shorter (amp;lt;0.001) in RALS group than LT group. Health care costs for RALS was significantly lower (mean difference $1568 USD/(sic)1225 Euro, p amp;lt; 0.05). Conclusion: Our results demonstrate non-inferiority in paraaortic lymph node count, comparable complication rates, shorter hospital length and lower total cost for RALS over laparotomy. Generalisability of the latter finding requires a high-volume setting and high surgical proficiency. In women with high-risk endometrial cancer confined to the uterus, RALS is a valid treatment modality. Clinical trials registrations: ClinicalTrials.gov NCT01847703. (C) 2017 Elsevier Ltd. All rights reserved.
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9.
  • Salehi, Sahar, et al. (författare)
  • Increasingly better diagnosis and treatment of endometrial cancer : Allt bättre diagnostik och behandling vid endometriecancer
  • 2015
  • Ingår i: Läkartidningen. - 0023-7205. ; 112
  • Tidskriftsartikel (refereegranskat)abstract
    • Endometrial cancer is the most common gynecological cancer in developed countries and the observed rise in incidence is mainly caused by life style factors including obesity and diabetes. The management of the disease has undergone major changes in the past 5-10 years. Morphological and genetic studies constitute the basis for the new classification of the disease, and data emerging from the Cancer Genome Atlas suggest that genomic patterns differ within the two types of endometrial cancer. The prognosis seems to be related to occult lymphatic spread but the role of lymphadenectomy is heavily debated. Development of novel biomarkers, sentinel lymph node technique and refined radiological methods may reduce the need of comprehensive staging in the future. The results from the Cancer Genome Atlas suggest that women with endometrial cancer may benefit from »targeted therapies« in the evolving era of personalised medicine.
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10.
  • Salehi, Sahar (författare)
  • Robot-assisted laparoscopy and sentinel node biopsy in high risk endometrial cancer
  • 2018
  • Doktorsavhandling (övrigt vetenskapligt)abstract
    • Surgery is standard treatment for early stage endometrial cancer (EC), the most common gynaecological malignancy in developed countries. Traditionally, surgery has been performed by laparotomy (LT). Comprehensive surgical staging, including pelvic (PLND) and paraaortic (PALND) lymph node dissection, is associated with morbidity and possible reduction in quality of life. Minimally invasive surgery (MIS) is associated with less morbidity, albeit newer MIS techniques, i.e. robot-assisted laparoscopic surgery (RALS), has not been compared with LT in a randomised setting. The sentinel lymph node technique is well established in other malignancies, however, the experience in EC is limited. The aim of this thesis was to evaluate if RALS for PLND and infrarenal PALND (IRPALND) in women with high risk EC is noninferior to LT in harvesting lymph nodes, to investigate short- and long-term morbidity as well as quality of life. We also wanted to evaluate the sentinel lymph node biopsy concept as a diagnostic tool for detecting lymph node metastases (LNM). In the RASHEC trial, we randomised 120 women with stage I-II EC with high-risk tumour features to hysterectomy, bilateral salpingo-oophorectomy, PLND and IRPALND by either RALS or LT between 2013 and 2016. Primary endpoint was paraaortic lymph node count. Patient-reported outcome (EORTC QLQ-C30 and the endometrial cancer module EN-24, EQ- 5D for generic health status) was assessed before surgery and 12 months after surgery. Computed tomography (CT) was performed at baseline, 3 and 12 months after surgery. Patient characteristics were evenly distributed between the two groups. In the per protocol analysis of 96 patients, difference of means with a 95% confidence interval was within the noninferiority margin for infrarenal paraaortic lymph node count (-1.6, 95% CI -5.78 - 2.57). No difference in perioperative complications (Clavien-Dindo classification) or readmissions to hospital within 30 days after surgery was found. RALS was associated with longer operation time (p<0.001) but less total blood loss (p<0.001), shorter hospital stay (p<0.001) and lower health care cost (p<0.05) compared to LT. We found no difference in self-reported lower limb lymphoedema, occurrence of lymphocysts, serious adverse events or admission to hospital for any reason between the two groups 12 months after surgery. Moreover, there was no difference in health-related quality of life. The Sentinel node in High Risk Endometrial Cancer (SHREC- study) is a prospective nonrandomised trial recruiting consecutive patients from two tertiary referral centres in Sweden (Lund and Stockholm) between 2014 and 2018 where each woman served as her own control. In total 261 patients underwent pelvic sentinel node biopsy followed by completion lymphadenectomy of which 257 were analysed. The sentinel lymph node biopsy algorithm applied in the SHREC-trial demonstrated a sensitivity for detection of LNM of 100% (95% CI 92-100) and a negative predictive value of 100% (95% CI 98-100). This thesis demonstrates that RALS is non-inferior to LT in harvesting infrarenal paraaortic lymph nodes. RALS was associated with shorter hospital stay and lower health care cost and there were no evident differences in morbidity or quality of life. Consequently, we find RALS to be a valid option for comprehensive surgical staging including IRPALND in high risk endometrial cancer. The choice of surgical modality should be made based on surgeons’ and patient preference. The sentinel lymph node biopsy algorithm has a satisfactory bilateral mapping rate and complete detection of LNM, corroborating previous reports. Gold standard diagnostic lymphadenectomy in women EC should therefore be replaced by the less invasive sentinel lymph node biopsy.
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