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Sökning: WFRF:(Eriksson Ane Gerda Zahl) > Falconer Henrik > Robot-assisted appr...

  • Falconer, HenrikKarolinska Institutet,Karolinska Institute,Karolinska Inst, Sweden (författare)

Robot-assisted approach to cervical cancer (RACC) : an international multi-center, open-label randomized controlled trial

  • Artikel/kapitelEngelska2019

Förlag, utgivningsår, omfång ...

  • 2019-06-14
  • BMJ Publishing Group Ltd,2019
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:oru-75730
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-75730URI
  • https://doi.org/10.1136/ijgc-2019-000558DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-162341URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-392872URI
  • https://lup.lub.lu.se/record/6483bb96-8701-4479-a6a8-4e0cd63dd729URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:141472766URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-159588URI
  • https://gup.ub.gu.se/publication/283387URI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Funding Agencies|Stockholms Lans Landsting
  • 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 (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.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Palsdottir, KolbrunKarolinska Institutet,Karolinska Institute,Karolinska Inst, Sweden (författare)
  • Stålberg, KarinUppsala University,Uppsala universitet,Reproduktiv hälsa,Uppsala Univ, Sweden(Swepub:uu)kariglim (författare)
  • Dahm-Kähler, Pernilla,1964Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences(Swepub:gu)xdahmp (författare)
  • Ottander, UlrikaUmeå University,Umeå universitet,Obstetrik och gynekologi,Umea Univ, Dept Clin Sci, Med Fak, Umea, Sweden(Swepub:umu)ulaotr95 (författare)
  • Lundin, EvelynLinköpings universitet,Linköping University,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten(Swepub:liu)evelu82 (författare)
  • Wijk, Lena,1971-Örebro University,Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Orebro Univ, Fac Med & Hlth, Orebro, Sweden(Swepub:oru)lwk (författare)
  • Kimmig, RainerGynecology and Obstetrics, University Hospital of Duisburg-Essen, Essen, Germany,Univ Hosp Duisburg Essen, Gynecol & Obstet, Essen, Germany (författare)
  • Jensen, Pernille TineFaculty of Health Science, Aarhus University, Aarhus, Denmark,Aarhus Univ, Fac Hlth Sci, Aarhus, Denmark (författare)
  • Eriksson, Ane Gerda ZahlGynecologic Oncology, Universitetet i Oslo, Oslo, Norway,Univ Oslo, Gynecol Oncol, Oslo, Norway,University of Oslo (författare)
  • Mäenpää, JohannaFaculty of Medicine and Medical Technology, Tampere University, Tampere, Pirkanmaa, Finland,Tampere Univ, Fac Med & Med Technol, Tampere, Finland (författare)
  • Persson, JanLund University,Lunds universitet,Obstetrik och gynekologi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Obstetrics and Gynaecology (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital,Lund Univ Hosptial, Sweden(Swepub:lu)gyn-jpe (författare)
  • Salehi, SaharKarolinska Institutet,Karolinska Institute,Karolinska Inst, Sweden (författare)
  • Karolinska InstitutetKarolinska Institute (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:International Journal of Gynecological Cancer: BMJ Publishing Group Ltd29:6, s. 1072-10761048-891X1525-1438

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