Performance of Large Loop Excision of the Transformation Zone (LLETZ) in Women with Cervical Dysplasia in the Follicular Phase Versus the Luteal Phase of the Menstrual Cycle: a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Intraoperative blood loss (weight)
研究概览
简要总结
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.
详细描述
HPV and dysplasia of the uterine cervix
Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide. The prevalence in both male and female populations is high. Epidemiological estimates suggest that 85-91% of sexually active adults acquire at least one genital HPV infection by the age of 50, with approximately 95% of HPV infections being spontaneously eliminated within 2 years in terms of HPV immunological clearance. HPV preferentially infects the epithelial cells of the anogenital area and, through incorporation of HPV DNA into the host genome of the basal cells of the squamous epithelium of the cervix and subsequent expression of viral components, causes dysplastic changes in the cervical epithelium that, if left untreated, can develop into invasive carcinoma of the cervix (cervical carcinoma). Cervical carcinoma is the fourth most common cancer as well as the fourth leading cause of cancer-related death in women worldwide, responsible for 6.6% (570,000) of all new cancer cases and 7.5% (311,000) of cancer-related deaths in women in 2018. The precursor of squamous cell carcinoma of the uterine cervix (approximately 80% of all cervical cancers) is cervical intraepithelial neoplasia (CIN), which has three grades of expression (CIN1, CIN 2, and CIN 3). Compared with invasive cervical carcinoma, the incidence of precancerous lesions of the cervix uteri is much higher. It is estimated that approximately 100,000 women in Germany develop high-grade dysplasia (CIN2/CIN3) each year.
Therapy of cervical dysplasia
Dysplasia of the cervix is typically detected during the gynecological screening examination at the gynecologist. Smears are taken from the ectocervix and endocervix and cytologically evaluated for dysplastic cells and smear quality after Papanicolaou staining. For further clarification of dysplastic changes, presentation to a specialized dysplasia consultation is recommended in the case of abnormalities with suspected presence of cervical dysplasia. Histological confirmation of abnormal areas is performed during colposcopic examination. The histopathological processing of the tissue samples and the colposcopic image of the spread of the changes in the cervix then allow individualized therapy planning.
Conization as the standard of surgical treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Surgeons will not be provided information about the menstrual cycle
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Intraoperative blood loss (weight)
时间窗: During surgery
The intraoperative blood loss, measured by the net-weight (in grams) of the surgical swabs used for hemostasis
次要结局
- Postoperative bleeding (days)(Interview 14 days after surgery)
- Intraoperative blood loss (Hb)(Day of surgery)
- Patient's anxiety(On the day of surgery, before surgery)
- Rate of complications(During surgery up to 14 days post surgery)
- Patient satisfaction(At discharge and 14 days after surgery)
- Intraoperative blood loss (subjective)(Immediately after surgery)
- Cone mass(During surgery, immediately after the excision)
- Postoperative bleeding (subjective)(Interview 14 days after surgery)
- Procedure duration(At surgery)
研究者
Clemens Tempfer
Director, Department of Obstetrics and Gynecologiy
Ruhr University of Bochum