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

NCT05391243 | Not Yet Recruiting

• 1 other identifier: LLETZ-MC-1
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Dysplasia

Keywords

cervical dysplasia; LLETZ; LEEP; conization; menstrual cycle

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss (weight)

  The intraoperative blood loss, measured by the net-weight (in grams) of the surgical swabs used for hemostasis

  During surgery

Secondary Outcomes (9)

• Intraoperative blood loss (Hb)

  Day of surgery

• Intraoperative blood loss (subjective)

  Immediately after surgery

• Postoperative bleeding (subjective)

  Interview 14 days after surgery

• Postoperative bleeding (days)

  Interview 14 days after surgery

• Patient's anxiety

  On the day of surgery, before surgery

Study Arms (2)

Follicular phase

OTHER

LLETZ performed during the follicular phase of the menstrual cycle

Procedure: LLETZ

Luteal phase

OTHER

LLETZ performed during the luteal phase of the menstrual cycle

Procedure: LLETZ

Interventions

LLETZ PROCEDURE

Large loop excision of the transformation zone

Also known as: LEEP, conization

Follicular phase; Luteal phase

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Marien Hospital Herne

Herne, North Rhine-Westphalia, 44625, Germany

Location

Related Publications (17)

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  PMID: 26704328 BACKGROUND

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  PMID: 15602247 BACKGROUND

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  BACKGROUND

• Gungorduk K, Ozdemir A, Sahin O. Optimal timing of the loop electrosurgical excision procedure according to different phases of the menstrual cycle. J Gynecol Obstet Hum Reprod. 2021 May;50(5):101888. doi: 10.1016/j.jogoh.2020.101888. Epub 2020 Aug 16.

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  PMID: 12052589 BACKGROUND

Related Links

• German S3 Guidelines

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Conization

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Clemens B. Tempfer, MD, MBA

  Ruhr-Universität Bochum / Marien Hospital Herne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clemens B. Tempfer, MD, MBA

CONTACT

+492323499; clemens.tempfer@rub.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Surgeons will not be provided information about the menstrual cycle
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Obstetrics and Gynecologiy

Model Details: Prospective randomized trial with 2 groups (follicular phase, luteal phase)

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: March 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After publication of the study results, no time limit.
• Access Criteria: Reasonable request, approval of the intended study by an independent review committee identified for this purpose.

Locations

DE (1)