Abstract
Background & objectives:
The World Health Organization (WHO) has endorsed thermal ablation (thermocoagulation) as an efficient and safe modality for treatment of cervical pre-cancer lesions. More evidence is being looked up by WHO through rigorous studies for health delivery models using screen-and-treat strategies incorporating thermal ablation and studies comparing it against the conventional standard modality cryotherapy. The objective of this study was to assess the acceptability of thermal ablation both among the providers and clients and compare the same with cryotherapy.
Methods:
A randomized control trial was conducted for one year from September 2019 to October 2020 after obtaining ethics approval. Computer-generated random number table was used for randomization, and eligible candidates were divided into two groups following informed consent. Women with visual inspection with acetic acid (VIA) positive cervical lesions in Group A received cryotherapy and Group B received thermal ablation. After the procedure, the acceptability of the provider and the client were assessed using the International Agency for Research on Cancer-validated questionnaire for both the procedures. Immediate side effects and problems at six weeks and at six months were assessed as well. Efficacy was decided by the absence of VIA positivity at six months.
Results:
The overall VIA positivity in this study was 11.8 per cent. Thermal ablation (thermocoagulation) had better provision and client acceptability than cryotherapy (significant difference). The efficacy of thermal ablation was 97.6 per cent, while, it was 92 per cent for cryotherapy (not significant).
Interpretation & conclusions:
In the context of screen-and-treat programme in settings such as India, thermal ablation appears to be a better method of treatment than cryotherapy for cervical pre-cancerous lesions particularly in terms of better provision and client acceptability.
Keywords: Pre-cancerous cervical lesions, thermal ablation – thermocoagulation, VIA test
Effective execution of cervical cancer prevention programme requires good liaison between screening and treatment. In settings with low resources, the World Health Organization (WHO) recommends visual inspection with acetic acid (VIA) as a screening test due to its requirement for limited infrastructure and consumables and ability to yield immediate result1-3. The WHO 20194 guidelines presented two approaches for screening and treatment of carcinoma cervix. The first one is the ‘screen-and-treat’ approach. In this, the decision of treatment relies on a single screening test (i.e. without any further screening or definitive histopathological diagnosis). The second one is ‘screen, triage and treat’ approach, in which if the first screening test comes out to be positive, the decision of treatment is taken by the second screening test (triage test) with or without histological diagnosis.
Treatment options for pre-cancerous cervical lesions include ablative and excisional procedures. Ablative [thermal ablation (thermocoagulation) and cryotherapy] procedures are technically easier and safer than excisional ones (cold-knife conization and loop electrosurgical excision procedure).
The 2013 version of the WHO guidelines5 and comprehensive cervical cancer control manual: a guide to essential practice (C4GEP)6 for the treatment of pre-cancerous cervical lesions did not include thermal ablation. However, emerging evidence supported the benefits and popularity of thermal ablation and insisted upon evaluating this alternative ablation technique. Subsequently, the WHO endorsed thermal ablation (thermocoagulation) as an efficient and safe option for the treatment of pre-cancerous cervical lesions4.
The recommendation of thermal ablation as a treatment option for VIA-positive lesions by the WHO is however conditional, and it is based on low assurance in evidence of effects. More evidence is being looked up by the WHO through rigorous studies for health delivery models using screen-and-treat strategies incorporating thermal ablation and studies comparing it against the conventional standard modality cryotherapy6.
Hence, the present study was intended to assess the acceptability of thermal ablation for both providers and clients as well as compare the efficacy of it against that of cryotherapy.
Material & Methods
This randomized controlled trial was carried out in the department of Obstetrics & Gynaecology, King George’s Medical University, Lucknow for a period of one year from September 2019 to October 2020 after procuring Institutional Ethical Clearance. For screening of female attendees at the department at the study centre (a government set up), the WHO-endorsed VIA testing (screen-and-treat approach) was adopted in this study for the see-and-treat programme. Cases were recruited by conducting VIA (using 5% acetic acid) on outpatient department (OPD) individuals. The VIA test was done by a resident doctor who examined the participants first time at the OPD. The VIA test interpretation being observer dependent, was carried out only by second- and third-year residents who were appropriately trained. This was also done to ensure a reduction in overtreatment rate. Women who were VIA positive and were eligible according to the inclusion criteria were registered in the study. Service providers in this study were faculty and senior residents of the department who were well trained and experienced in doing both the procedures; cryotherapy and thermal ablation to assess provider acceptability; each provider performed both the procedures as planned so as to have a comparative account. Participants from both groups were allotted to every provider. Providers were labelled as A1B1, A2B2, A3B3, A4B4, A5B5 etc. Each provider performed one cryotherapy and one thermal ablation procedure in the respective randomized group. Hence, 46 providers performed a total of 92 procedures (46 cryotherapy and 46 thermal ablation).
Inclusion and exclusion criteria: Inclusion criteria were the individuals giving consent to participate in the study, women in age bracket of 30 and 50 yr, VIA positive lesions, lesions covering <75 per cent of the ectocervix and Type 1 transformation zone (TZ). Pregnancy, women <12 wk postpartum, women treated for cervical cancer previously, the lesion involving more than three quadrants of TZ, Type 2 and 3 TZ, lesion extending into the vaginal wall and clinical suspicion of invasive cancer were exclusion criteria in the study. Computer-generated random number table was used for randomization. Women with VIA positive cervical lesions in Group A received cryotherapy, and Group B received thermal ablation. Participants in Group A were identified serially as A1 through A46 and in Group B were identified as B1 through B46.
Sample size: Calculation of sample size was done, as per the proportion of one-year free cases in the study group and assumption of equality under the null hypothesis using the formula,
where p1=0.85 (85%), the proportion of one-year disease-free cases (82) p2=p1, under the assumption of the null hypothesis of equality coefficient difference e=0.2, Type I error considered to be clinically significant, α=5 per cent and Type II error β=10 per cent with the power of the study 90 per cent. The number of cases was aimed to be n=46 in each group.
Study participants: Prior to obtaining written consent, women were explained about the VIA procedure, treatment options and potential adverse effects. Cryotherapy in Group A was performed using the standard double-freeze technique (which includes 3 min freeze-5 min thaw-3 min freeze-thaw); equipment with the following specifications (Basco Cryos India, version 2019, Chennai, Tamil Nadu, India) was used. Women in Group B were treated with Thermo coagulator (WISAP® Medical Technology GmbH, version: 6001, Brunnthal/Hofolding, Germany). The probe was heated to 100°C and applied on the cervix for 40 sec. If required, the application was repeated for the same duration to cover the whole transformation zone. For sterilization, the probe was heated to 120°C for about 60 sec.
Procedure for assessment: Following the procedures, provider acceptability was assessed using the International Agency for Research on Cancer (IARC)-validated questionnaire7 for thermal ablation (provided as Supplementary material). This questionnaire is specifically designed for thermal ablation providers. The present study compared provider acceptability for cryotherapy vs. thermal ablation. Hence, for the cryotherapy questionnaire, modifications were made in the IARC thermal ablation questionnaire related to questions on cryotherapy per se. Since an appropriate comparison pertaining to provider acceptability for cryotherapy and thermal ablation was required, after performing the procedure, each provider was requested to fill the Provider Acceptability Questionnaire for each procedure (thermal ablation and cryotherapy) they conducted. For assessing provider acceptability, 46 questionnaires for cryotherapy vs. 46 questionnaires for thermal ablation filled by 46 providers for 92 participants were used. The degree of satisfaction with the procedure was assessed under various parameters such as ease of setting up and use of instrument, satisfaction with probe length and shape and acceptability of the procedure by the women. For answering every question, the questionnaire included a grading system such as – ease of setting up and use of instrument – (i) very easy, (ii) easy, (iii) normal, (iv) not easy, (v) difficult and (vi) no opinion. For answering this question, the provider answered by ticking any of the above. Likewise, for a question – are you satisfied with the probe length and shape – gradings were (i) very satisfied, (ii) satisfied, (iii) normal, (iv) quite satisfied, (v) dissatisfied and (vi) no opinion, and the provider answered by ticking any of the above. Technical problems, such as the instrument stopping working, timer not showing time properly, probe getting loosened, while using the instrument were also recorded by the provider. For studying provider experience with ablation of the cervix with qualitative methods, there was one descriptive question also in the questionnaire in which providers were asked to write about their views on the benefits and problems associated with both options.
In order to assess participant acceptability, the questions as follows were asked; pain during or immediately after the procedure along with its intensity (recorded using a Numeric Rating Scale)8. Immediate complaints such as bleeding per vagina, shivering, heat sensation in the vagina, dizziness and fainting were noted. Patient’s level of satisfaction was measured as a score between 1 and 10. If a participant was least satisfied, the score was (1-3), if satisfied, the score was (4-6) and on highly satisfied, the score was (7-10).
No antibiotics or analgesics were routinely advised after the treatment. All participants were counselled about the probable adverse effects and complications of treatment and were advised to contact if they experienced heavy bleeding, high fever lasting more than two days, crampy pain and any foul-smelling discharge. Avoiding vaginal medication, douching and sexual intercourse for six weeks were advised. Follow up visits were scheduled at six weeks and six months post-treatment. At six weeks, treated individuals were assessed for any side effects, and a per speculum examination was done to note the healing of the cervix and the colour, amount and consistency of the vaginal discharge (if present). At six months follow-up, VIA was done along with the examination of the cervix for any residual, recurrent or persistent disease. Efficacy was determined by the absence of VIA positivity after six months of treatment.
Statistical analysis: Data were collected, and percentages, frequencies and mean with standard deviation were calculated. For categorical variables, the Chi-square test was used. The Fisher t test was used as appropriate. The independent t test was used to compare the continuous variables; P<0.05 value was considered as statistically significant. SPSS (Statistical Package for the Social Sciences) version 21.0 statistical analysis software (IBM Corp., Armonk, NY, USA) was used in the present study.
Results
Of the 880 women screened, 104 women were VIA positive. Out of 104, 12 were excluded from the study (three women had VIA positive lesion occupying more than 3/4 of the TZ, seven women declined to undergo the treatment due to fear of procedure and two women declined to come for follow up as they lived far away). A total of 92 VIA positive women were enrolled, and a computer-generated random number table was used for randomization. In Group A, there were three lost to follow up; individuals at six weeks and a total of five participants did not come for six-month follow up. The remaining 41 participants came for six-month follow up. Out of 46 women in Group ‘B’ who underwent thermal ablation, one participant did not turn up for six-week follow up, and there were three lost to follow up at six months. The rest 42 participants came for their six-month follow up. At six months, 42 women from Group A and 41 from Group B came for follow up visits (Figure). The demographic profile of participants in the two groups was similar as shown in Table I; majority was from lower middle socioeconomic category.
Figure.
Enrolment of subjects, their allocation to treatment (cryotherapy and thermal ablation), acceptability assessment, their follow up at six weeks and six months.
Table I.
Comparison of sociodemographic and reproductive health characteristics between two groups
| Variable | Cryotherapy (n=46), n (%) | Thermal ablation (n=46), n (%) | Total (n=92), n (%) |
|---|---|---|---|
| Age (yr) | |||
| 30-39 | 29 (63) | 26 (56.5) | 55 (59.8) |
| 40-50 | 17 (37) | 20 (43.5) | 37 (40.2) |
| Mean age (yr) | 37.15±6.17 | 38.52±6.16 | 37.84±6.17 |
| Age at menarche (yr) | 12.93±0.93 | 13.13±1.09 | 13.03±1.01 |
| Age at consummation (yr) | 20.26±2.42 | 20.49±2.08 | 20.38±2.25 |
| Age at first childbirth (yr) | 22.28±2.32 | 22.48±2.57 | 22.38±2.44 |
| Parity | |||
| 0-1 | 6 (13) | 5 (10.9) | 11 (12) |
| 2-4 | 35 (76.1) | 38 (82.6) | 73 (79.3) |
| >4 | 5 (10.9) | 3 (6.5) | 8 (8.7) |
| Socioeconomic status | |||
| Upper middle | 6 (13) | 4 (8.7) | 10 (10.9) |
| Middle | 26 (56.5) | 33 (71.7) | 59 (64.1) |
| Lower middle | 13 (28.3) | 8 (17.4) | 21 (22.8) |
| Lower | 1 (2.2) | 1 (2.2) | 2 (2.2) |
Table II and III shows clinical symptom distribution and the area of aceto-whitening in both the groups, respectively. It was found that maximum participants had two-quadrant involvement.
Table II.
Comparison of presenting complaints between the two groups
| Presenting complaint | Cryotherapy (n=46), n (%) | Thermal ablation (n=46), n (%) | Total (n=92), n (%) |
|---|---|---|---|
| Abdominal pain | 12 (26.1) | 18 (39.1) | 30 (32.6) |
| Backache | 4 (8.7) | 1 (2.2) | 5 (5.4) |
| Vaginal discharge less than six months | 15 (32.6) | 10 (21.7) | 25 (27.2) |
| Vaginal discharge more than six months | 8 (17.4) | 9 (19.6) | 17 (18.5) |
| Foul-smelling vaginal discharge | 3 (6.5) | 0 | 3 (3.3) |
| Vaginal itching | 1 (2.2) | 1 (2.2) | 2 (2.2) |
| Dysmenorrhoea | 3 (6.5) | 2 (4.3) | 5 (5.4) |
| Dyspareunia | 1 (2.2) | 2 (4.3) | 3 (3.3) |
| Menorrhagia | 4 (8.7) | 7 (15.2) | 11 (12) |
| Oligomenorrhoea | 1 (2.2) | 2 (4.3) | 3 (3.3) |
| Hypomenorrhoea | 2 (4.3) | 3 (6.5) | 5 (5.4) |
Table III.
Comparison of acetowhite area (AWA) in two groups
| AWA size | Cryotherapy (n=46), n (%) | Thermal ablation (n=46), n (%) | Total (n=92), n (%) |
|---|---|---|---|
| One quadrant | 26 (56.5) | 25 (54.3) | 51 (55.4) |
| Two quadrants | 19 (41.3) | 19 (41.3) | 38 (41.3) |
| Three quadrants | 1 (2.2) | 2 (4.3) | 3 (3.3) |
While exploring the advantages associated with the two procedures in consideration, 60.9 per cent of the providers informed that thermal ablation had fewer side effects compared to cryotherapy. A little over half of the providers (56.5 per cent) mentioned thermal ablation as a quicker method and easier to perform. Other advantages mentioned by different providers included portability, good acceptability by the participants, easier way of sterilization, low maintenance cost, electricity-driven device and no need of heavy gas cylinders as needed in cryotherapy. Table IV compares provider acceptability between the two groups. Fifteen providers (32.6%) stated that cryotherapy was worse than thermal ablation; 7 (15.2%) providers had faced interruption while performing the procedure. The rest 8 (17.39%) felt that cryotherapy was more time-consuming and cumbersome to set up, whereas thermal ablation was quicker, easy to handle, and it was more comfortable for both the patient and the provider.
Table IV.
Comparison of provider acceptability between the two groups
| Points of inquiry | Cryotherapy (n=46), n (%) | Thermal ablation (n=46), n (%) | Total (n=92), n (%) |
|---|---|---|---|
| Ease of use of instrument | |||
| Normalδ | 11 (23.9) | 2 (4.3) | 13 (14.1) |
| Easy | 21 (45.7) | 10 (21.7)*** | 31 (33.7) |
| Very easy | 14 (30.4) | 34 (73.9) | 48 (52.2) |
| Not easy | 0 | 0 | 0 |
| Difficult | 0 | 0 | 0 |
| No opinion | 0 | 0 | 0 |
| Satisfaction with probe length and shape | |||
| Normal | 4 (8.7) | 0 | 4 (4.3) |
| Satisfied | 28 (60.9) | 7 (15.2) | 35 (38) |
| Very satisfied | 14 (30.4) | 39 (84.8) *** | 53 (57.6) |
| Quite dissatisfied | 0 | 0 | 0 |
| Dissatisfied | 0 | 0 | 0 |
| No opinion | 0 | 0 | 0 |
| Ease of setting up of instrument | |||
| Normal | 15 (32.6) | 4 (8.7) | 19 (20.7) |
| Not easy | 2 (4.3) | 0 | 2 (2.2) |
| Easy | 19 (41.3) | 7 (15.2) | 26 (28.3) |
| Very easy | 10 (21.7) | 35 (76.1) *** | 45 (48.9) |
| Difficult | 0 | 0 | 0 |
| No opinion | 0 | 0 | 0 |
| Acceptability by the participants | |||
| Acceptable with no side effect | 15 (32.6) | 19 (41.3) | 34 (37) |
| Acceptable with very few sides effects | 31 (67.4) | 27 (58.7) | 58 (63) |
| Not acceptable with side effects | 0 | 0 | 0 |
| Instrument stop working | |||
| No | 41 (89.1) | 46 (100) | 87 (94.6) |
| Yes | 5 (10.9) | 0 | 5 (5.4) |
| Timer not showing the time correctly | |||
| No | 46 (100) | 46 (100) | 92 (100) |
| Yes | 0 | 0 | 0 |
| Battery problems/gas leak issue | |||
| No | 44 (95.7) | 46 (100) | 90 (97.8) |
| Yes | 2 (4.3) | 0 | 2 (2.2) |
| Probe become loose | |||
| No | 46 (100) | 46 (100) | 92 (100) |
| Yes | 0 | 0 | 0 |
| Preference vis-à-vis thermal ablation/cryotherapy for the same indication | |||
| Better | 0 | 39 (84.8) *** | 39 (42.4) |
| No difference | 0 | 7 (15.2) | 7 (15.2) |
| Worse | 0 | 0 | 0 |
| Preference vis-à-vis LEEP for the same indication | |||
| Better | 46 (100) | 46 (100) | 46 (100) |
| No difference | 0 | 0 | 0 |
| Worse | 0 | 0 | 0 |
| Recommendation of thermal ablation/cryotherapy to other colleagues | |||
| Yes | 39 (84.8) | 46 (100) ** | 85 (92.4) |
| No | 7 (15.2) | 0 | 7 (7.6) |
| Satisfaction about sterilization procedure | |||
| Less satisfied | 46 (100) | 0 | 46 (50) |
| Satisfied | 0 | 46 (100) *** | 46 (50) |
P *<0.05, **<0.01, ***<0.001. δNormal: Means that the provider did not find any difference on a particular question. LEEP, loop electrosurgical excision procedure
The efficacy of thermal ablation was 97.6 per cent, and that for cryotherapy was 92 per cent; however, this difference was not significant (Supplementary Table I). Supplementary Tables I and II provide details about the side effects experienced by two groups of participants.
Supplementary Table I.
Comparison of assessment for efficacy after six months with visual inspection with acetic acid (VIA) between two groups
| Efficacy of the treatment | Cryotherapy (n=41), n (%) | Thermal ablation (n=42), n (%) |
|---|---|---|
| VIA negative | 38 (92.7) | 41 (97.6) |
| VIA positive | 3 (7.3) | 1 (2.4) |
Supplementary Table II.
Comparison of side effects and level of satisfaction as reported by service providers between the two groups
| Side effects | Cryotherapy (n=46), n (%) | Thermal ablation (n=46), n (%) | Total (n=92), n (%) |
|---|---|---|---|
| No complaint | 15 (32.6) | 19 (41.3) | 34 (37) |
| Abdominal pain | |||
| Mild (1-3) | 13 (28.3) | 5 (10.9) * | 18 (19.6) |
| Moderate (4-6) | 0 | 0 | 0 |
| Severe (7-10) | 0 | 0 | 0 |
| Backache | |||
| Mild (1-3) | 3 (6.5) | 2 (4.3) | 5 (5.4) |
| Moderate (4-6) | 1 (2.2) | 0 | 1 (1.1) |
| Severe (7-10) | 0 | 0 | 0 |
| Heat sensation in the vagina | 0 | 3 (6.5) | 3 (3.3) |
| Shivering | 3 (6.5) | 0 | 3 (3.3) |
| Spotting per vaginum | 2 (4.3) | 0 | 2 (2.2) |
| Heavy vaginal bleeding | 0 | 0 | 0 |
| Dizziness | 1 (2.2) | 0 | 1 (1.1) |
| Fainting | 0 | 0 | 0 |
| Level of satisfaction | |||
| Least satisfied | 0 | 0 | 0 |
| Satisfied | 5 (10.9) | 1 (2.2) | 6 (6.5) |
| Highly satisfied | 41 (89.1) | 45 (97.8) | 86 (93.5) |
| Mean score for level of satisfaction | 8.50±1.43 | 9.33±0.99** | 8.91±1.29 |
| Will recommend the procedure to others | |||
| Yes | 39 (84.8) | 44 (95.7) | 83 (90.2) |
| No | 1 (2.2) | 0 | 1 (1.1) |
| Cannot say | 6 (13) | 2 (4.3) | 8 (8.7) |
| Participants assessed | 43 | 45 | 88 |
| No complaint | 10 (23.3) | 32 (71.1) *** | 42 (47.7) |
| Persistent vaginal discharge | 17 (39.5) | 5 (11.1) ** | 22 (25) |
| New-onset vaginal discharge | 5 (11.6) | 4 (8.9) | 9 (10.2) |
| Persistent pain abdomen | 4 (9.3) | 1 (2.2) | 5 (5.7) |
| New-onset pain abdomen | 4 (9.3) | 2 (4.4) | 6 (6.8) |
| Backache | 2 (4.7) | 0 | 2 (2.3) |
| Participants assessed | 41 | 42 | 83 |
| No complaint | 37 (90.2) | 41 (97.6) | 78 (94) |
| On-off vaginal discharge | 3 (7.3) | 1 (2.4) | 4 (4.8) |
| Foul-smelling vaginal discharge | 1 (2.4) | 0 | 1 (1.2) |
P* <0.05, **<0.001
Discussion
In the present study, the VIA positivity rate was 11.8 per cent, which was comparable with the findings of Chigbu et al9, and Bhatla et al10 (range: 12.7%–14.2%). The study conducted by Sinha et al11 (35.6%) reported a higher rate. Pinder et al 12 conducted their study in Zambia, which is amongst the top five countries with cervical cancer explaining the high VIA positivity rate. Noticeably, VIA is a subjective test, and for testing the procedure’s efficacy, histopathological diagnosis serves as the gold standard, and this is one of the limitations of the present study.
For studying provider acceptability – we objectively assessed provider’s satisfaction with the procedure followed. On comparing the ease of use of instrument, more providers found thermal ablation easier compared to cryotherapy. This difference could be attributed to the longer duration of the procedure of cryotherapy (11 min) compared to thermal ablation (less than a minute). It was inconvenient for the provider to hold the cryoprobe still for so long although none of the providers found any of the procedures to be ‘not easy’ or ‘difficult’. Easy use of thermal ablation by providers was recorded as shown in systematic observations from the WHO GDG (2019)6 and, therefore, was more acceptable than cryotherapy or large loop excision of the transformation zone (LLETZ). However, the updated WHO guidelines (2021)13 mention that women eligible for ablative therapy can be administered any one of the ablative techniques. The reason for better acceptability for thermo-coagulator probe was, unlike a cryoprobe, a thermos probe is available in various different shapes (flat, nibbled and conical), which can be used according to the provider’s clinical judgement of transformation zone and size and depth of acetowhite area. None of the providers were ‘dissatisfied’ with any of the procedures. However, there was a marked difference in the ‘very satisfied’ category between the two groups. This may be because the setting up of the cryotherapy instrument (e.g. connecting the cryoprobe to the gas cylinder, mobilizing the gas cylinder and checking the pressure in the cylinder) is cumbersome and more time-consuming. On the other hand, thermo-coagulator is lightweight, portable and easy to set up.
In Campbell et al’s14 study, providers perceived greater acceptability of thermal ablation by women and anecdotally reported fewer treatment sequelae. As per the systematic observations from the WHO GDG (2019)6, acceptability of thermal ablation is more, and it is because it takes less time. The present study had similar findings with high positive perception of the providers, for acceptability and also good client acceptability. Technical issues like loose probe were neither reported in the cryotherapy group nor in the thermal ablation group. However, empty gas cylinders and gas leaks were logistic issues that were recorded in the study. In the study conducted by Paul et al15, providers reported challenges associated with cryotherapy in the form of difficulties in ensuring gas supply; local technicians could not restore the cryotherapy machine when it stopped working. Regarding the use of cryotherapy, the WHO GDG (2019)6 states that a defaulter happens if women do not get treatment in the same sitting due to the non-availability of gas and the women do not return to the centre.
Findings on advantages of thermal ablation, as identified in the present study, were comparable with those reported by Campbell et al’s14, in which providers reported shorter treatment duration with thermal ablation and perceived greater acceptability by women. Naud et al16 also mentioned about similar advantages of thermal ablation such as shorter treatment time, low morbidity and high acceptability amongst patients and providers. Sinha et al11 interpreted that thermal ablation was much preferred by care providers and was quicker. Thermal ablation has an initial high investment cost; however, as per the meta-analysis conducted by Randall et al17, thermal ablation offers advantage over cryotherapy, which makes it more useful in low-resource settings with portability, easy-to-use features. Viviano et al18 further stated that thermal ablation was a valuable option due to its accessibility, effectiveness, and ease of transportation. During the present investigation, a few providers mentioned about the possibility of burn injury to the vaginal wall as the device was pre-heated; however, they agreed that with caution, this could be prevented. The majority of the providers stated that thermal ablation had no significant disadvantages, which was comparable to the findings of Pinder et al12. A meta-analysis19 concludes that thermal ablation does not have any practical disadvantage of cryotherapy, and is a superior therapeutic option for screen-and-treat programmes in low-resource settings. As in our study, the systemic observations from the WHO GDG (2019)6 also mentioned that thermal ablation caused pain in fewer women than compared to cryotherapy.
Better provider and client acceptability may become a decisive factor in choosing one modality over the other. Better patient acceptability will ensure more success of the ‘screen-and-treat’ programme at mass, and better provider acceptability will give us more confidence for tackling the situation. In the context of the screen-and-treat programme in lower- and lower–middle-income countries, thermal ablation, based on the present study findings, appears to be a better method of treatment than cryotherapy for cervical pre-cancerous lesions.
Financial support and sponsorship
None.
Conflicts of interest
None.
Acknowledgment:
International Agency for Research on Cancer (IARC) is duly acknowledged for their validated questionnaire.
Supplementary material
THERMOCOAGULATION ACCEPTABILITY QUESTIONNAIRE FOR PROVIDERS
-
Characteristics of provider:
Name:
Institute:
Date of Procedure:
-
Degree of satisfaction:
1. Ease of use of thermocoagulator:
a. Very easy: b. Easy: c. Normal:
d. Not easy: e. difficult: f. no opinion:
2. Are you satisfied with the probe length and shape:
a. Very satisfied b. satisfied c. normal
d. Quite dissatisfied e. dissatisfied f. no opinion
3. Ease of setting up of temperature
a. Very easy: b. Easy: c. Normal:
d. Not easy: e. difficult: f. no opinion:
4. Acceptability by women:
a. Acceptable with no side effects.
b. Acceptable with very few side effects
c. Not acceptable with side effects
-
Technical problems faced by you:
1. Instruments stop working: Yes No
2. Timer not showing the time correctly Yes No NA
3. Battery problems Yes No NA
4. Probe becomes loose Yes No NA
5. Other’s specify
6. Recommendation of thermocoagulation to colleagues: Yes No
7. Preference vis-à-vis cryotherapy for the same indications: Better No difference Worse
8. Preference vis-à-vis LEEP for the same indications: Better No difference Worse
9. Satisfaction about sterilization procedure:
-
Procedure:
1. Do you use local anaesthesia
2. Duration of treatment per application (in seconds)
-
Sterilization procedures followed by you:
1. Heating the probe: Yes No
2. For how many seconds
3. Soak in Cidex (R) or disinfectant: Yes No
4. Others specify
-
Please write your comments on:
1. Advantages of thermocoagulator over cryotherapy:
2. Disadvantages of thermo-coagulator over cryotherapy:
CRYOTHERAPY ACCEPTABILITY QUESTIONNAIRE FOR PROVIDERS
-
Characteristics of provider:
Name :
Institute:
Date of Procedure
-
Degree of satisfaction:
1. Ease of use of cryotherapy instrument:
a. Very easy: b. Easy: c. Normal:
d. Not easy: e. difficult: f. no opinion:
2. Are you satisfied with the probe length and shape?
a. Very satisfied b. satisfied c. normal
d. Quite dissatisfied e. dissatisfied f. no opinion
3. Ease of setting up of pressure
a. Very easy: b. Easy: c. Normal:
d. Not easy: e. difficult: f. no opinion:
4. Acceptability by women:
a. Acceptable with no side effects.
b. Acceptable with very few side effects
c. Not acceptable with side effects
-
Technical problems faced by you:
1. Instruments stop working: Yes No
2. Timer not showing the time correctly Yes No NA
3. Gas leak issues Yes No NA
4. Probe becomes loose Yes No NA
5. Other’s specify
6. Recommendation of cryotherapy to colleagues: Yes No
7. Preference vis-à-vis thermocoagulation for the same indications: Better No difference Worse
8. Preference vis-à-vis LEEP for the same indications: Better No difference Worse
9. Satisfaction about sterilization procedure:
-
Procedure:
1. Do you use local anaesthesia
2. Duration of treatment per application (in minutes)
-
Sterilization procedures followed by you:
1. Heating the probe: Yes No
2. For how many seconds
3. Soak in Cidex (R) or disinfectant: Yes No
4. Others specify.
-
Please write your comments on:
1. Advantages of cryotherapy over thermocoagulator
2. Disadvantages of cryotherapy over thermocoagulator
CLIENT ACCEPTABILITY QUESTIONNAIRE
GROUP: A / B PROCEDURE-
Name- Age-
Husband Name- Religion-
Address-
Contact no-
Married for-
Age at marriage-
Age at first intercourse-
Parity- Contraception-
Menopausal- (If yes, specify years since menopause)
Socioeconomic status- Upper middle Lower middle Upper lower Lower
Education status: Graduate Intermediate High school Middle school Primary Illiterate
Presenting Complaint(s) with duration:
Per Speculum examination:
Post-procedure complaints:
Pain/discomfort (score 1-10)
Burning sensation- Yes / No
Shivering- Yes / No
Per vaginal bleeding – Yes / No
Watery discharge – Yes / No
Dizziness – Yes / No
Fainting – Yes / No
Level of satisfaction (score 1-10)
Least satisfied (1-3)
Satisfied (4-6)
Highly satisfied (7-10)
Would you recommend this procedure to other patients?
Yes
No
Cannot say
References
- 1.Sankaranarayanan R, Nessa A, Esmy PO, Dangou JM. Visual inspection methods for cervical cancer prevention. Best Pract Res Clin Obstet Gynaecol. 2012;26:221–32. doi: 10.1016/j.bpobgyn.2011.08.003. [DOI] [PubMed] [Google Scholar]
- 2.Szarewski A. Cervical screening by visual inspection with acetic acid. Lancet. 2007;370:365–6. doi: 10.1016/S0140-6736(07)61171-4. [DOI] [PubMed] [Google Scholar]
- 3.Visual inspection with acetic acid for cervical-cancer screening:test qualities in a primary-care setting. University of Zimbabwe/JHPIEGO cervical cancer project. Lancet. 1999;353:869–73. [PubMed] [Google Scholar]
- 4.World Health Organization (WHO). WHO guidelines for screening and treatment of pre-cancer lesions for cervical cancer prevention. [accessed on January 14, 2022]. Available from: https://www.who.int/reproductivehealth/call-to-actionelimination-cervical-cancer/en .
- 5.World Health organization (WHO) Comprehensive cervical cancer control: A guide to essential practice. 2nd ed. Geneva, Switzerland: WHO Press; 2014. [PubMed] [Google Scholar]
- 6.World Health Organization (WHO). WHO guidelines for the use of thermal ablation for cervical pre-cancer lesions. [accessed on January 2, 2021]. Available from: https://iris.who.int/bitstream/handle/10665/329299/9789241550598-eng.pdf?sequence=1 . [PubMed]
- 7.International Agency for research on Cancer. Quistionnaire to the therm-coagulator providers. [accessed on January 2, 2021]. Available from: https://scr.datacollect.iarc.fr/redcap/surveys/?s=AFJNNAMRR4 .
- 8.Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018;36:707–14. doi: 10.1016/j.ajem.2018.01.008. [DOI] [PubMed] [Google Scholar]
- 9.Chigbu CO, Onwudiwe EN, Onyebuchi AK. Thermo-coagulation versus cryotherapy for treatment of cervical precancers: A prospective analytical study in a low-resource African setting. J Obstet Gynaecol Res. 2020;46:147–52. doi: 10.1111/jog.14139. [DOI] [PubMed] [Google Scholar]
- 10.Bhatla N, Gulati A, Mathur SR, Rani S, Anand K, Muwonge R, et al. Evaluation of cervical screening in rural North India. Int J Gynaecol Obstet. 2009;105:145–9. doi: 10.1016/j.ijgo.2008.12.010. [DOI] [PubMed] [Google Scholar]
- 11.Sinha P, Srivastava P, Srivastava A. Comparison of visual inspection with acetic acid and the pap smear for cervical cancer screening. Acta Cytol. 2018;62:34–8. doi: 10.1159/000484036. [DOI] [PubMed] [Google Scholar]
- 12.Pinder LF, Parham GP, Basu P, Muwonge R, Lucas E, Nyambe N, et al. Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: Pilot phase of a randomised controlled trial. Lancet Oncol. 2020;21:175–84. doi: 10.1016/S1470-2045(19)30635-7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.World Health Organization (WHO) WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention. 2nd ed. [accessed on July 6, 2021]. Available from: https://www.who.int/publications/i/item/9789240030824 . [PubMed]
- 14.Campbell C, Kafwafwa S, Brown H, Walker G, Madetsa B, Deeny M, et al. Use of thermo-coagulation as an alternative treatment modality in a 'screen-and-treat'programme of cervical screening in rural Malawi. Int J Cancer. 2016;139:908–15. doi: 10.1002/ijc.30101. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Paul P, Winkler JL, Bartolini RM, Penny ME, Huong TT, Nga Le T, et al. Screen-and-treat approach to cervical cancer prevention using visual inspection with acetic acid and cryotherapy: Experiences, perceptions, and beliefs from demonstration projects in Peru, Uganda, and Vietnam. Oncologist. 2013;18:6–12. doi: 10.1634/theoncologist.18-S2-6. [DOI] [PubMed] [Google Scholar]
- 16.Naud PS, Muwonge R, Passos EP, Magno V, Matos J, Sankaranarayanan R. Efficacy, safety, and acceptability of thermocoagulation for treatment of cervical intraepithelial neoplasia in a hospital setting in Brazil. Int J Gynaecol Obstet. 2016;133:351–4. doi: 10.1016/j.ijgo.2015.09.035. [DOI] [PubMed] [Google Scholar]
- 17.Randall TC, Sauvaget C, Muwonge R, Trimble EL, Jeronimo J. Worthy of further consideration: An updated meta-analysis to address the feasibility, acceptability, safety and efficacy of thermal ablation in the treatment of cervical cancer precursor lesions. Prev Med. 2019;118:81–91. doi: 10.1016/j.ypmed.2018.10.006. [DOI] [PubMed] [Google Scholar]
- 18.Viviano M, Kenfack B, Catarino R, Tincho E, Temogne L, Benski AC, et al. Feasibility of thermocoagulation in a screen-and-treat approach for the treatment of cervical precancerous lesions in sub-Saharan Africa. BMC Womens Health. 2017;17:2. doi: 10.1186/s12905-016-0355-x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Dolman L, Sauvaget C, Muwonge R, Sankaranarayanan R. Meta-analysis of the efficacy of cold coagulation as a treatment method for cervical intraepithelial neoplasia: A systematic review. BJOG. 2014;121:929–42. doi: 10.1111/1471-0528.12655. [DOI] [PubMed] [Google Scholar]