Large Loop Excision of the Transformation Zone (LLETZ) with Vs Without IntraOperative Application of Lugol's Iodine

Launched by RUHR UNIVERSITY OF BOCHUM · Nov 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a surgical procedure called Large Loop Excision of the Transformation Zone (LLETZ) for treating cervical dysplasia, which are abnormal cells on the cervix that could lead to cancer if not removed. The trial aims to compare two methods: one that uses a special iodine solution during the surgery to help identify healthy tissue and guide the removal of the affected area, and another that does not use iodine. The goal is to see if using iodine can help reduce the chance of leaving behind any abnormal cells after surgery.

To participate in this trial, women aged 18 and older who have confirmed cervical dysplasia through a previous examination may be eligible, provided they can give informed consent and have not had prior treatments on their cervix. Unfortunately, those who are pregnant, have certain medical conditions, or allergies to iodine cannot take part. If you join the study, you can expect to undergo the LLETZ procedure with either method, and you will be monitored for the effectiveness of the treatment. This research is important as it seeks to improve surgical outcomes and reduce the risk of cervical cancer in women.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Written consent
• • Colposcopy performed preoperatively
• • Histologically (by previously performed colposcopy) confirmed dysplasia (CIN 1, CIN 2 or CIN 3)
• • Age \>18 years
• Exclusion Criteria:
• • Pregnant patients
• • Patients with insufficient knowledge of the German language
• • Treatments already performed on the cervix uteri, in particular conization
• • Blood coagulation disorders
• • Taking blood thinning substances
• • Iodine allergy