Viviano Manuela, Kenfack Bruno, Catarino Rosa, Tincho Eveline, Temogne Liliane, Benski Anne-Caroline, Tebeu Pierre-Marie, Meyer-Hamme Ulrike, Vassilakos Pierre, Petignat Patrick
Division of Gynaecology, Department of Gynaecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
Division of Gynecology, Geneva University Hospitals, Boulevard de la Cluse 30, 1205, Geneva, Switzerland.
BMC Womens Health. 2017 Jan 7;17(1):2. doi: 10.1186/s12905-016-0355-x.
The use of thermocoagulation for the treatment of cervical precancerous lesions has recently generated a great deal of interest. Our aim was to determine the feasibility of this outpatient procedure in the context of a cervical cancer (CC) screen-and-treat campaign in sub-Saharan Africa.
Between July and December 2015, women living in the area of Dschang (Cameroon) aged between 30 and 49 years, were enrolled in a CC screening study. HPV self-sampling was performed as a primary screening test and women who were either "HPV 16/18/45-positive" or "positive to other HPV types and to VIA" were considered screen-positive, thus requiring further management. The primary outcome was the percentage of screen-positive patients who met the criteria to undergo thermocoagulation. The secondary outcome was the assessment of the procedure's side effects immediately after treatment and at the 1-month follow-up visit.
A total of 1012 women were recruited in the study period. Among 121 screen-positive women, 110 of them (90.9%) were eligible to be treated with thermocoagulation. No patients discontinued treatment because of pain or other side effects. The mean ± SD (Standard Deviation) score measured on the 10-point Visual Analogue Scale (VAS) was 3.0 ± 1.6. Women having less than 2 children were more likely to report a higher pain score than those with more than two (4.2 ± 2.0 versus 2.9 ± 1.5, respectively; p value = 0.016). A total of 109/110 (99.1%) patients came to the 1-month follow-up visit. Vaginal discharge was reported in 108/109 (99.1%) patients throughout the month following treatment. Three patients (2.8%) developed vaginal infection requiring local antibiotics. No hospitalizations were required.
The majority of screen-positive women met the criteria and could be treated by thermocoagulation. The procedure was associated to minor side effects and is overall feasible in the context of a CC screen-and-treat campaign in sub-Saharan Africa.
The trial was retrospectively registered on November 11, 2015 with the identifier: ISRCTN99459678 .
热凝术用于治疗宫颈癌前病变最近引起了广泛关注。我们的目的是确定在撒哈拉以南非洲的宫颈癌筛查与治疗活动中，这种门诊手术的可行性。
2015年7月至12月期间，居住在喀麦隆雅温得地区、年龄在30至49岁之间的女性参加了一项宫颈癌筛查研究。HPV自我采样作为主要筛查测试，“HPV 16/18/45阳性”或“其他HPV类型及VIA阳性”的女性被视为筛查阳性，因此需要进一步处理。主要结局是符合热凝术标准的筛查阳性患者的百分比。次要结局是治疗后立即及1个月随访时对该手术副作用的评估。
研究期间共招募了1012名女性。在121名筛查阳性的女性中，110名（90.9%）符合热凝术治疗条件。没有患者因疼痛或其他副作用而停止治疗。在10分视觉模拟量表（VAS）上测得的平均±标准差（SD）评分为3.0±1.6。子女少于2个的女性比子女多于2个的女性更有可能报告更高的疼痛评分（分别为4.2±2.0和2.9±1.5；p值=0.016）。共有109/110（99.1%）名患者前来进行1个月随访。治疗后的整个月内，108/109（99.1%）名患者报告有阴道分泌物。3名患者（2.8%）发生阴道感染，需要局部使用抗生素。无需住院治疗。
大多数筛查阳性的女性符合标准，可以接受热凝术治疗。该手术的副作用较小，总体上在撒哈拉以南非洲的宫颈癌筛查与治疗活动中是可行的。
该试验于2015年11月11日进行回顾性注册，标识符为：ISRCTN99459678。
