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  • 1.
    Falconer, Henrik
    et al.
    Karolinska Inst, Sweden.
    Palsdottir, Kolbrun
    Karolinska Inst, Sweden.
    Stalberg, Karin
    Uppsala Univ, Sweden.
    Dahm-Kahler, Pernilla
    Sahlgrens Acad, Sweden.
    Ottander, Ulrika
    Umea Univ, Sweden.
    Lundin, Evelyn
    Linköping University, Department of Clinical and Experimental Medicine, Division of Children's and Women's health. Linköping University, Faculty of Medicine and Health Sciences.
    Wijk, Lena
    Orebro Univ, Sweden.
    Kimmig, Rainer
    Univ Hosp Duisburg Essen, Germany.
    Jensen, Pernille Tine
    Aarhus Univ, Denmark.
    Eriksson, Ane Gerda Zahl
    Univ Oslo, Norway.
    Maenpaa, Johanna
    Tampere Univ, Finland.
    Persson, Jan
    Lund Univ Hosptial, Sweden.
    Salehi, Sahar
    Karolinska Inst, Sweden.
    Robot-assisted approach to cervical cancer (RACC): an international multi-center, open-label randomized controlled trial2019In: International Journal of Gynecological Cancer, ISSN 1048-891X, E-ISSN 1525-1438, Vol. 29, no 6, p. 1072-1076Article in journal (Refereed)
    Abstract [en]

    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 amp;gt;7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (alpha) of 5% and a power (1-beta) 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.

  • 2.
    Lundin, Evelyn
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Division of Children's and Women's health. Linköping University, Faculty of Medicine and Health Sciences.
    Borendal Wodlin, Ninnie
    Linköping University, Department of Clinical and Experimental Medicine, Division of Children's and Women's health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Nilsson, Lena
    Linköping University, Department of Medical and Health Sciences, Division of Drug Research. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Anaesthesiology and Intensive Care in Linköping (ANOPIVA).
    Kjölhede, Preben
    Linköping University, Department of Clinical and Experimental Medicine, Division of Children's and Women's health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    A prospective randomized assessment of quality of life between open and robotic hysterectomy in early endometrial cancer2019In: International Journal of Gynecological Cancer, ISSN 1048-891X, E-ISSN 1525-1438, Vol. 29, no 4, p. 721-727Article in journal (Refereed)
    Abstract [en]

    Objective There are limited prospective data on the evaluation of quality of life in patients undergoing robotic hysterectomy for endometrial cancer. Our objective was to determine whether post-operative recovery differs between robotic and abdominal hysterectomy.

    Methods At a Swedish tertiary referral university hospital, 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included in a randomized trial. Surgery was performed according to principles for minimal invasive surgery. Anesthesia and peri-operative care followed a standardized enhanced recovery after surgery program in both groups. The EuroQol Group form EQ-5D and the Short Form-36 were used to evaluate patients' health-related quality of life. The Swedish Postoperative Symptoms Questionnaire assessed symptoms pre-operatively, daily for 7 days from the day of surgery, and then weekly until 6 weeks post-operatively. Data were analyzed by means of non-parametric tests and repeated measures ANOVA. To evaluate the time-dependent occurrence of complications, Kaplan-Meier survival and Cox proportional-hazard models were used.

    Results A total of 50 women were enrolled in the study (25 robotic and 25 abdominal hysterectomy). Median age (68 years vs 67 years), estimated blood loss (50 mL vs 50 mL), length of hospital stay de facto (53 hours vs 51 hours), and time to meet discharge criteria (36 hours vs 36 hours) in the robotic and abdominal groups, respectively, did not differ significantly (p>0.05) Women in the robotic hysterectomy group recovered significantly faster (p=0.01) in the EQ-5D health index, and reached their pre-operative level after approximately 3 weeks, nearly 2 weeks earlier than the abdominal group. Differences regarding improvement in health-related quality of life (Short Form-36) were statistically significant in general health and social functioning only, and were in favor of robotic hysterectomy. Consumption of analgesics, pain intensity, and symptom sum score post-operatively were equal. Occurrence of complications was an independent risk factor and influenced significantly the EQ-5D health index, length of hospital stay, pain intensity, opioid consumption, and symptom sum score adversely.

    Conclusion Robotic hysterectomy in the setting of an enhanced recovery after surgery program led to faster recovery in health-related quality of life compared with abdominal hysterectomy.

  • 3.
    Serreyn Lundin, Evelyn
    Linköping University, Department of Clinical and Experimental Medicine, Division of Children's and Women's health. Linköping University, Faculty of Medicine and Health Sciences.
    On Quality Improvement in Gynaecological Cancer Surgery2020Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    Objectives: The overall purpose of this thesis was to find medical and surgical treatment methods of improving the perioperative care of gynaecological cancer patients. The specific objectives were to determine whether a single dose tranexamic acid given immediately before surgery for presumed advanced ovarian cancer reduces perioperative blood loss and the need for blood transfusions, and to determine whether postoperative recovery, tissue damage, and inflammatory response markers differ between women operated with robotic and abdominal hysterectomy for low-risk endometrial cancer in an enhanced recovery after surgery (ERAS) programme, and to evaluate costs for hospital stay and postoperative recovery in relation to health impact.

    Material and Methods: The thesis was based on two randomised trials. The first trial was a randomised double-blind placebo-controlled multicentre study conducted in four hospitals in the southeast and central of Sweden between March 2008 and May 2012. One hundred women with presumed advanced ovarian cancer who had been scheduled for radical debulking surgery were included; 50 received tranexamic acid and 50 received a placebo. The main outcomes were blood loss and red blood cell transfusions. The second trial was a randomised open single centre trial at a Swedish university hospital, which included 50 women with low-risk endometrial cancer scheduled for radical surgery between February 2012 and May 2016; 25 women underwent robotic hysterectomy and 25 had abdominal hysterectomy. Anaesthesia and perioperative care followed an ERAS protocol in both groups. The EuroQol Group form EQ-5D-3L and the Short Form-36 evaluated the health-related quality of life. The Swedish Postoperative Symptoms Questionnaire assessed symptoms perioperatively until six weeks postoperatively. Venous blood samples were collected on several occasions until six weeks postoperatively and were analysed for markers reflecting inflammatory response and tissue damage. In addition, a health economic evaluation was conducted comparing total costs, qualityadjusted life years (QALYs) and cost per QALY between the surgical methods.

    Results: Total blood loss volume and transfusion rate following surgery in advanced ovarian cancer were significantly lower in the tranexamic group compared with the placebo group. Women with early endometrial cancer treated by robotic hysterectomy recovered significantly faster in the EQ-5D health index, and reached their preoperative level nearly two weeks earlier than the abdominal group. Differences regarding improvement in health-related quality of life (Short Form-36) comprising general health and social functioning were more favourable in the robotic hysterectomy group. Consumption of analgesics, pain intensity, postoperative symptom sum score and length of hospital stay were equal between the groups. The occurrence of complications was an independent risk factor and influenced most of the outcome measures adversely. Postoperative inflammatory response and tissue damage were lower after robotic hysterectomy compared with the abdominal approach. The robotic group gained more QALYs until six weeks after surgery than the abdominal group but the total costs were higher. The total cost per QALY gained was quite high for the robotic procedure.

    Conclusions: A single dose of tranexamic acid given immediately before surgery reduces blood loss and transfusion rates in advanced ovarian cancer surgery. Robotic hysterectomy in an ERAS programme treating early endometrial cancer leads to a faster recovery in the health-related quality of life than abdominal hysterectomy, the latter being strongly influenced by perioperative complications. Less tissue damage and inflammation might contribute to a faster recovery in the robotic group. Robotic hysterectomy provides more QALYs until six weeks postoperatively but with a substantially higher total cost for the society.

    List of papers
    1. Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: double-blind placebo-controlled randomized multicenter study
    Open this publication in new window or tab >>Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: double-blind placebo-controlled randomized multicenter study
    Show others...
    2014 (English)In: Acta Obstetricia et Gynecologica Scandinavica, ISSN 0001-6349, E-ISSN 1600-0412, Vol. 93, no 4, p. 335-344Article in journal (Refereed) Published
    Abstract [en]

    ObjectiveTo determine whether single-dose tranexamic acid given intravenously immediately before surgery for presumed advanced ovarian cancer reduces perioperative blood loss and blood transfusions. DesignA randomized double-blind, placebo-controlled multicenter study. SettingTwo university hospitals and two central hospitals in the southeast health region of Sweden. PopulationOne hundred women with presumed advanced ovarian cancer scheduled for radical debulking surgery between March 2008 and May 2012 who complied with inclusion/exclusion criteria were randomized; 50 were allocated to receive tranexamic acid and 50 to receive placebo. Analysis was performed according to intention-to-treat principles. MethodsThe volume of tranexamic acid (15mg/kg body weight, 100mg/mL tranexamic acid) or the same volume of placebo (0.9% NaCl) was added to a 100-mL saline solution plastic bag. The study medication was given immediately before the start of surgery. Data were analyzed by means of non-parametric statistics and multivariate models adjusted for confounding factors. Main outcome measuresBlood loss and red blood cell transfusions. ResultsThe total blood loss volume and transfusion rate were significantly lower in the tranexamic acid group compared with the placebo group. Median total blood loss was 520 and 730mL, respectively (p=0.03). Fifteen (30%) and 22 (44%), respectively received transfusions (odds ratio 0.44; upper 95% CI 0.97; p=0.02). ConclusionA single dose of tranexamic acid given immediately before surgery reduces blood loss and transfusion rates significantly in advanced ovarian cancer surgery. Tranexamic acid may be recommended as standard prophylactic treatment in advanced ovarian cancer surgery.

    Place, publisher, year, edition, pages
    Informa Healthcare / Wiley, 2014
    Keywords
    Blood loss; ovarian cancer; randomized trial; surgery; tranexamic acid; transfusion
    National Category
    Clinical Medicine
    Identifiers
    urn:nbn:se:liu:diva-106118 (URN)10.1111/aogs.12333 (DOI)000333150700003 ()
    Available from: 2014-04-25 Created: 2014-04-24 Last updated: 2019-12-10
    2. A prospective randomized assessment of quality of life between open and robotic hysterectomy in early endometrial cancer
    Open this publication in new window or tab >>A prospective randomized assessment of quality of life between open and robotic hysterectomy in early endometrial cancer
    2019 (English)In: International Journal of Gynecological Cancer, ISSN 1048-891X, E-ISSN 1525-1438, Vol. 29, no 4, p. 721-727Article in journal (Refereed) Published
    Abstract [en]

    Objective There are limited prospective data on the evaluation of quality of life in patients undergoing robotic hysterectomy for endometrial cancer. Our objective was to determine whether post-operative recovery differs between robotic and abdominal hysterectomy.

    Methods At a Swedish tertiary referral university hospital, 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included in a randomized trial. Surgery was performed according to principles for minimal invasive surgery. Anesthesia and peri-operative care followed a standardized enhanced recovery after surgery program in both groups. The EuroQol Group form EQ-5D and the Short Form-36 were used to evaluate patients' health-related quality of life. The Swedish Postoperative Symptoms Questionnaire assessed symptoms pre-operatively, daily for 7 days from the day of surgery, and then weekly until 6 weeks post-operatively. Data were analyzed by means of non-parametric tests and repeated measures ANOVA. To evaluate the time-dependent occurrence of complications, Kaplan-Meier survival and Cox proportional-hazard models were used.

    Results A total of 50 women were enrolled in the study (25 robotic and 25 abdominal hysterectomy). Median age (68 years vs 67 years), estimated blood loss (50 mL vs 50 mL), length of hospital stay de facto (53 hours vs 51 hours), and time to meet discharge criteria (36 hours vs 36 hours) in the robotic and abdominal groups, respectively, did not differ significantly (p>0.05) Women in the robotic hysterectomy group recovered significantly faster (p=0.01) in the EQ-5D health index, and reached their pre-operative level after approximately 3 weeks, nearly 2 weeks earlier than the abdominal group. Differences regarding improvement in health-related quality of life (Short Form-36) were statistically significant in general health and social functioning only, and were in favor of robotic hysterectomy. Consumption of analgesics, pain intensity, and symptom sum score post-operatively were equal. Occurrence of complications was an independent risk factor and influenced significantly the EQ-5D health index, length of hospital stay, pain intensity, opioid consumption, and symptom sum score adversely.

    Conclusion Robotic hysterectomy in the setting of an enhanced recovery after surgery program led to faster recovery in health-related quality of life compared with abdominal hysterectomy.

    Place, publisher, year, edition, pages
    BMJ Publishing Group Ltd, 2019
    National Category
    Surgery
    Identifiers
    urn:nbn:se:liu:diva-158346 (URN)10.1136/ijgc-2019-000285 (DOI)000469455500010 ()30923082 (PubMedID)2-s2.0-85068140980 (Scopus ID)
    Note

    Funding Agencies|Medical Research Council of South East Sweden; County Council of Ostergotland; Linkoping University; manufacturer of the robotic equipment Intuitive Surgery

    Available from: 2019-07-02 Created: 2019-07-02 Last updated: 2019-12-10Bibliographically approved
1 - 3 of 3
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