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A phase III randomized clinical trial comparing laparoscopic radical hysterectomy based on open state with abdominal radical hysterectomy in patients with early-stage cervical cancer.

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  • Author(s): Zhao X;Zhao X; Liu Y; Liu Y; Niu J; Niu J; Shi Y; Shi Y
  • Source:
    Trials [Trials] 2024 Jul 11; Vol. 25 (1), pp. 471. Date of Electronic Publication: 2024 Jul 11.
  • Publication Type:
    Journal Article; Clinical Trial Protocol; Comparative Study
  • Language:
    English
  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BioMed Central, 2006-
    • Subject Terms:
      Uterine Cervical Neoplasms*/surgery ; Uterine Cervical Neoplasms*/mortality ; Uterine Cervical Neoplasms*/pathology ; Hysterectomy*/methods ; Hysterectomy*/adverse effects ; Laparoscopy*/adverse effects ; Laparoscopy*/methods ; Randomized Controlled Trials as Topic* ; Neoplasm Staging*; Humans ; Female ; Treatment Outcome ; Clinical Trials, Phase III as Topic ; Adult ; Middle Aged ; Lymph Node Excision/adverse effects ; Lymph Node Excision/methods ; Quality of Life
    • Abstract:
      Background: Cervical cancer is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer death in women, The standard treatment recommendation for women with early cervical cancer is radical hysterectomy with pelvic lymph node dissection, however, articles published in recent years have concluded that the treatment outcome of laparoscopic surgery for cervical cancer is inferior to that of open surgery. Thus, we choose a surgically new approach; the laparoscopic cervical cancer surgery in the open state is compared with the traditional open cervical cancer surgery, and we hope that patients can still have a good tumor outcome and survival outcome. This trial will investigate the effectiveness of laparoscopic cervical cancer surgery in the open-state treatment of early-stage cervical cancer.
      Method and Design: This will be an open-label, 2-armed, randomized, phase-III single-center trial of comparing laparoscopic radical hysterectomy based on open state with abdominal radical hysterectomy in patients with early-stage cervical cancer. A total of 740 participants will be randomly assigned into 2 treatment arms in a 1:1 ratio. Clinical, laboratory, ultrasound, and radiology data will be collected at baseline, and then at the study assessments and procedures performed at baseline and 1 week, 6 weeks, and 3 months, and follow-up visits begin at 3 months following surgery and continue every 3 months thereafter for the first 2 years and every 6 months until year 4.5. The primary aim is the rate of disease-free survival at 4.5 years. The secondary aims include treatment-related morbidity, costs and cost-effectiveness, patterns of recurrence, quality of life, pelvic floor function, and overall survival.
      Conclusions: This prospective trial aims to show the equivalence of the laparoscopic cervical cancer surgery in the open state versus the transabdominal radical hysterectomy approach for patients with early-stage cervical cancer following a 2-phase protocol.
      Trial Registration: ChiCTR2300075118. Registered on August 25, 2023.
      (© 2024. The Author(s).)
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    • Contributed Indexing:
      Keywords: Based on open state; Cervical cancer; Laparoscopic surgery; Phase III clinical trial; Radical hysterectomy
    • Publication Date:
      Date Created: 20240711 Date Completed: 20240712 Latest Revision: 20240831
    • Publication Date:
      20250114
    • Accession Number:
      PMC11238402
    • Accession Number:
      10.1186/s13063-024-08318-z
    • Accession Number:
      38992720