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

Launched by RUHR UNIVERSITY OF BOCHUM · May 20, 2022

Keywords

ClinConnect Summary

This clinical trial, called LLETZ-MC, is looking at the best timing for a specific surgical procedure called LLETZ (Large Loop Excision of the Transformation Zone) to treat cervical dysplasia, which are abnormal cells on the cervix that could lead to cervical cancer. The study aims to find out whether performing this surgery during the follicular phase (the first half of the menstrual cycle) results in less bleeding and makes patients feel more satisfied and less anxious compared to doing it during the luteal phase (the second half of the cycle). This could help improve recovery and overall patient experience.

To be eligible for this trial, participants should be women over 18 with a regular menstrual cycle and a confirmed diagnosis of cervical dysplasia. They must not be pregnant or have certain medical conditions, such as blood clotting disorders. If you decide to participate, you will receive care and monitoring throughout the process, and your experience will contribute to understanding how menstrual timing can impact surgical outcomes. This trial is not yet recruiting participants, so keep an eye out for updates if you or someone you know might be interested.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Written consent
• • Regular menstrual cycle, defined as an interval between 21 and 35 days and a bleeding duration between 3 and 10 days during the last 3 months
• • Colposcopy performed preoperatively
• • Histologically (by previously performed colposcopy) confirmed dysplasia (CIN 1, CIN 2 or CIN 3)
• • Suspicion of low-grade or high-grade squamous intraepithelial lesion based on Papanicolaou smear with inconclusive colposcopy and need for surgical workup to exclude lesions
• • Age \>18 years
• Exclusion Criteria:
• • Pregnant patients
• • Patients with insufficient knowledge of the German language
• • Pre-existing oncological diseases
• • Blood coagulation disorders
• • Taking blood thinning substances
• • Use of a hormonal intrauterine device (e.g. Mirena);
• • Use of a progesterone pill or progesterone injectate;
• • Use of long cycle contraceptive (no monthly bleeding).