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Large Loop Excision of the Transformation Zone During Follicular Vs. Luteal Phase of the Menstrual Cycle (LLETZ-MC)

Study acronym: LLETZ-MC
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Oct 2025 to Oct 2026
    • Start date: May 2024 to Mar 2025
    • Study completion date: Dec 2025 to Dec 2026
    v8
  2. Notable Primary completion date: Oct 2024 to Oct 2025
    • Start date: May 2023 to May 2024
    • Study completion date: Dec 2024 to Dec 2025
    v7
  3. Notable Start date: Feb 2023 to May 2023
    • Primary completion date: Jul 2024 to Oct 2024
    • Study completion date: Sep 2024 to Dec 2024
    v6
  4. Notable Primary completion date: Dec 2023 to Jul 2024
    • Start date: Sep 2022 to Feb 2023
    • Study sites: 0 to 1
    • Study completion date: Mar 2024 to Sep 2024
    v5
  5. Notable Lead sponsor: Clemens Tempfer to Ruhr University of Bochumv4
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  1. Minor Re-verified, no change to tracked fieldsv3
  2. Minor Secondary endpoints: details revised at 2 of 9 entries
    • Eligibility criteria expanded, about 4 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cervical cancer is one of the most common cancers in women and one of the leading causes of death in women worldwide. Pre-cancerous lesions (dysplasias) are detected by the preventive smear test at the gynecologist and can thus contribute to a 100% chance of cure if they are clarified by a colposcopic examination as part of the dysplasia consultation and dysplastic lesions are then surgically removed if necessary (conization). There are few data in the literature on the influence of the menstrual cycle on the bleeding pattern during and after conization. Hormonal variations during the menstrual cycle affect both the extent of blood flow to reproductive organs and hemostasis. In the follicular phase, there is a decrease in local blood flow in the uterus and pelvic organs and an increase in coagulability. Conversely, in the luteal phase there is an increase in local blood supply and a decrease in coagulability. Therefore, it seems reasonable to perform conization in the follicular phase to possibly reduce the extent and incidence of bleeding and bleeding complications. This assumption is supported by clinical observations. For example, there is evidence from other specialties that selection of the timing of surgery, taking into account the menstrual phase, may influence the risk of bleeding. Another factor of interest in menstruation-based surgical planning is psychological vulnerability, which may also vary with the menstrual cycle. Until now, consideration of the menstrual cycle in surgical planning for conization has not been standard practice and there is no recommendation in this regard in the current S3 guideline of the German Society of Gynecology and Obstetrics. Therefore, this study now aims to answer the question under prospective randomized conditions whether LLETZ conization performed during the follicular phase results in lower blood loss and higher patient satisfaction and lower anxiety scores compared to LLETZ conization performed during the luteal phase.
Trial Details
NCT Number NCT05391243
Lead Sponsor Ruhr University of Bochum
Conditions
(from sponsor)
Cervical Dysplasia
Related terms Uterine Cervical Dysplasia
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov