BMC women's health · 2017
Feasibility of thermocoagulation in a screen-and-treat approach for the treatment of cervical precancerous lesions in sub-Saharan Africa.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Viviano Manuela, Kenfack Bruno, Catarino Rosa, Tincho Eveline, Temogne Liliane, Benski Anne-Caroline, Tebeu Pierre-Marie, Meyer-Hamme Ulrike, Vassilakos Pierre, Petignat Patrick
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
TRIAL REGISTRATION: The trial was retrospectively registered on November 11, 2015 with the identifier: ISRCTN99459678 .
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
TRIAL REGISTRATION: The trial was retrospectively registered on November 11, 2015 with the identifier: ISRCTN99459678 .