LLETZ procedure with and without Lugol's iodine application for cervical dysplasia
Large Loop Excision of the Transformation Zone (LLETZ) with Versus Without Intraoperative Application of Lugol's Iodine in Women with Cervical Dysplasia: a Prospective Randomized Trial
This study is testing if using Lugol's iodine during the LLETZ procedure helps doctors find and remove precancerous cells better in women with cervical dysplasia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ruhr University of Bochum Academic / other |
| Locations | 1 site (Herne, NRW) |
| Trial ID | NCT05132114 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the Large Loop Excision of the Transformation Zone (LLETZ) procedure for treating cervical dysplasia, comparing outcomes between patients who receive intraoperative application of Lugol's iodine and those who do not. The study aims to determine if the iodine test can enhance the identification and removal of precancerous lesions during surgery. Eligible participants will undergo a preoperative colposcopy and must have histologically confirmed dysplasia. The trial is conducted at Marien Hospital Herne under the auspices of Ruhr University of Bochum.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old with histologically confirmed cervical dysplasia (CIN 1, CIN 2, or CIN 3).
Not a fit: Patients who are pregnant, have prior cervical treatments, or have iodine allergies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the complete removal of precancerous cervical lesions, potentially reducing the risk of cervical cancer.
How similar studies have performed: While the use of Lugol's iodine in this context is not widely tested, similar approaches in enhancing surgical outcomes for cervical dysplasia have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Herne, NRW
- Marien Hospital Herne — Herne, Nrw, Germany (Recruiting)
Study contacts
- Principal investigator: Clemens B Tempfer, MD, MBA — Ruhr-Universität Bochum / Marien Hospital Herne
- Study coordinator: Clemens B Temfper, MD, MBA
- Email: clemens.tempfer@rub.de
- Phone: +492323499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.