Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

NCT04772937 | Recruiting

• 1 other identifier: LLETZ-2
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical dysplasia is the precursor of cervical cancer. LEEP and LLETZ are standard surgical procedures to treat cervical dysplasia. There is no direct head-to-head comparison between LEEP and LLETZ in the literature regarding oncologic safety, for which complete resection of the dysplastic lesion (so-called 'in-sano resection') is the most appropriate postoperative surrogate parameter. Further clinical studies are therefore useful to optimize surgical therapy for cervical dysplasia. The primary objective of the present study is to compare LLETZ (resection of the dysplastic lesion including the transformation zone) with targeted resection of the colposcopically conspicuous lesion only (LEEP) and to compare it with regard to oncological safety (defined as non-in-sano rate).

Conditions

Cervical Dysplasia

Keywords

cervical dysplasia; conization; surgery; cervical cancer; LLETZ; LEEP

Outcome Measures

Primary Outcomes (1)

• Surgical specimen margin status

  Oncological safety as defined by the rate of specimens with involved margins, i.e. cervical dysplasia present at the edge of the surgical specimen.

  Pathology assessment of the cone specimen (within 2-4 days after surgery)

Secondary Outcomes (5)

• Intraoperative and postoperative complication rate

  During and within 3 weeks after the procedure

• Cone size

  During surgery

• Patient's pain

  Immediately after the surgery

• HPV clearance

  6 months post surgery

• Cone volume

  During surgery

Study Arms (2)

LLETZ group

OTHER

LLETZ (large loop excision of the transformation zone) is one of several possible surgical interventions for treating cervical dysplasia.

Procedure: LLETZ

LEEP group

OTHER

LEEP (loop electrosurgical excision procedure) is one of several possible surgical interventions for treating cervical dysplasia.

Procedure: LEEP

Interventions

LLETZ PROCEDURE

LLETZ is one of several possible surgical interventions for treating cervical dysplasia. The transformation zone of the cervix is completely removed

Also known as: Large Loop Excision of the Transformation Zone

LLETZ group

LEEP PROCEDURE

LEEP is one of several possible surgical interventions for treating cervical dysplasia. Only the dysplastic lesion is removed without removing the whole transformation zone.

Also known as: Loop Electrosurgical Excision Procedure

LEEP group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)
• Colposcopically visible lesion
• No therapy of the disease so far

You may not qualify if:

• Taking immunosuppressive drugs (incl. glucocorticoids)
• Known HIV positivity
• Malignant disease requiring treatment
• Unsatisfactory colposcopy

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Dept. OBGYN Ruhr University Bochum

Herne, 44625, Germany

RECRUITING

Related Publications (2)

• Martin-Hirsch PP, Paraskevaidis E, Bryant A, Dickinson HO. Surgery for cervical intraepithelial neoplasia. Cochrane Database Syst Rev. 2013 Dec 4;2013(12):CD001318. doi: 10.1002/14651858.CD001318.pub3.

  PMID: 24302546 BACKGROUND

• Chua KL, Hjerpe A. Human papillomavirus analysis as a prognostic marker following conization of the cervix uteri. Gynecol Oncol. 1997 Jul;66(1):108-13. doi: 10.1006/gyno.1997.4753.

  PMID: 9234930 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Study Officials

• Clemens B Tempfer, MD, MBA

  Ruhr-Universität Bochum / Marien Hospital Herne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clemens B Temfper, MD, MBA

CONTACT

+492323499; clemens.tempfer@rub.de

Günther A Rezniczek, PhD

CONTACT

+492323499; guenther.rezniczek@rub.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient is anesthetized during surgery and will not recognize type of surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomization, 1:1 allocation, group 1: LLETZ, group 2: LEEP

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 26, 2021
• Study Start: June 7, 2021
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)