|Year : 2022 | Volume
| Issue : 3 | Page : 603-611
Randomized controlled study for comparison of efficacy and safety between thermocoagulation and cryotherapy in visual inspection with acetic acid positive cervical lesions
Manju Lata Verma, Uma Singh, Ruby Kumari, Rekha Sachan, Pushp Lata Sankhwar, Vandana Solanki
Department of Obstetrics and Gynaecology, KGMU, Lucknow, Uttar Pradesh, India
|Date of Submission||24-Apr-2021|
|Date of Acceptance||08-Jul-2021|
|Date of Web Publication||25-Jul-2022|
Manju Lata Verma
Department of Obstetrics and Gynaecology, KGMU, Lucknow, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Background: Less literature is available on the performance of thermocoagulation for treatment of premalignant cervical lesions and its comparison with cryotherapy from low- and middle-income countries like India.
Materials and Methods: A prospective randomized controlled study was done in the Department of Obstetrics and Gynecology from August 2018 to September 2019 after obtaining ethical clearance from Institutional Review Board (Reg no: ECR/262/Inst/Up/2013/RR/16) Ref no: 278/Ethics/R. cell-18). A total of 68 women with Visual inspection with acetic acid (VIA) positive cervical lesion were randomized into two groups. Group A was treated with cryotherapy and Group B was treated with thermocoagulation. Estimates of cure, adverse effects or complications were presented as frequencies, percentages, and mean ± standard deviation.
Results: Out of 667 patients, 624 patients underwent VIA testing among which 68 were VIA positive (10.89%, 68/624). The efficacy of thermocoagulation was 93.54% and that of cryotherapy was 90.32%. Immediate side effects were significantly lesser in thermocoagulation group (P = 0.008) in comparison to cryotherapy.
Conclusion: Thermocoagulation is better treatment modality than cryotherapy for VIA-positive cervical lesions may not be in terms of efficacy but definitely in terms of patient comfort and safety.
Keywords: Cervical cancer, cryotherapy, efficacy, safety, thermocoagulation, visual inspection with acetic acid
|How to cite this article:|
Verma ML, Singh U, Kumari R, Sachan R, Sankhwar PL, Solanki V. Randomized controlled study for comparison of efficacy and safety between thermocoagulation and cryotherapy in visual inspection with acetic acid positive cervical lesions. J Can Res Ther 2022;18:603-11
|How to cite this URL:|
Verma ML, Singh U, Kumari R, Sachan R, Sankhwar PL, Solanki V. Randomized controlled study for comparison of efficacy and safety between thermocoagulation and cryotherapy in visual inspection with acetic acid positive cervical lesions. J Can Res Ther [serial online] 2022 [cited 2022 Aug 10];18:603-11. Available from: https://www.cancerjournal.net/text.asp?2022/18/3/603/351879
| > Introduction|| |
Cervical cancer represents the fourth most common cancer among women worldwide and eighth most commonly occurring cancer overall. There were 5,69,847 new cases and 3, 11, 365 deaths reported worldwide due to cervical cancer. In India, cervical cancer is the second most common cancer among women. India has the highest incidence rate of cervical cancer as 22 per 1,00,000 women per year. Every year in India, 1,22,844 women are diagnosed with cervical cancer and 67,477 dies from the disease. Low- and middle-income countries (LMIC) share the burden of 80% of all cervical cancer cases. Morbidity and mortality of cervical cancer can be definitely decreased because most cases of cervical cancer are preventable by routine screening and treatment of precancerous lesions.
Various screening modalities for cervical precancerous lesions are Pap smear, liquid-based cytology, visual inspection with acetic acid (VIA)/visual inspection with Lugol's iodine, and Human papilloma virus (HPV) testing. Although population-based programs offering pap test every 3–5 years have reduced cervical cancer incidence and mortality in high-income countries, such programs have been less successful in reducing cervical cancer burden in LMICs due to poor organization, lack of coverage, and lack of quality assurance. In developing countries, only approximately 5% of eligible women undergo cytology-based screening in a 5-year period. This is because of availability of very few trained and skilled professionals to implement screening programs effectively. Further, due to delay in reporting of cytology results, women either do not collect their reports or do not receive adequate treatment. The challenges in introducing high-quality cytology screening in LMICs have led to the evaluation of alternative screening approaches such as VIA as a “single visit screen and treat.”
WHO has recommended VIA as an alternative to PAP smear in low resource setting. It is cheap and non-invasive and can be done in low-level health facilities. More importantly, VIA provides instant results and eligible candidates can receive treatment of the precancerous lesions using ablative procedure on the same day and in the same health facility. This “screen and treat” method ensures adherence to treatment soon after the diagnosis, so number of lost to follow-up patients are reduced.
VIA detects abnormal areas on the cervix by applying 3%–5% acetic acid. Acetic acid dehydrates the abnormal cells containing increased nuclear material and protein which turn acetowhite. Normal cells containing glycogen remain normal. It has a Sensitivity of 67.65% and specificity of 84.32%. VIA Lesions that require treatment are distinct, well defined, dense (opaque, dull or oyster white) acetowhite areas with regular or irregular margins close to or abutting the squamocolumnar junction (SCJ) in the transformation zone (TZ) or close to the external os if the SCJ is not visible.
Treatment modalities available for the treatment of precancerous lesions include ablative and excisional procedures. Ablative methods include cryotherapy and thermocoagulation. The excisional method includes Cold knife conization, large-loop excision of the TZ, and loop electrosurgical excision procedure. Ablative methods are preferred in low-grade lesions and in younger patients of child-bearing age. These are simpler treatment methods that can be performed as an outpatient basis and more conservative.
Cryotherapy is one of the ablative procedures that uses freezing gas to destroy precancerous cells on the cervix by crystallization of intracellular fluid. Freezing is done by using gases CO2 or N2O. It has an efficacy of 85%–92%. It does not require anesthesia and electricity and it is appropriate for nonphysician provider. However, it has certain disadvantages like it requires purchase of compressed gas, supply of which is expensive and often erratic in many LMICs, heavyweight of gas cylinder (15–20 Kg) and post procedure vaginal discharge. So, cryotherapy has failed to adequately address the problem in LMICs.
Globally, there is a pressing need for a simple treatment for cervical precancerous lesions. Current methods are expensive and difficult to implement on a large scale. In the given context, thermocoagulation represents an attractive alternative for the treatment of cervical precancerous lesion. It can be used in a single visit “screen and treat” approach and management of low-grade cervical precancerous lesions.
Thermal coagulation (also known as cold coagulation) has been used as an alternative ablative method for treating CIN lesions since 1980s. However, this method has a resurgence in view of easily portable and light equipment, less treatment time, faster patient turnover, less discomfort, use of minimal amounts of electricity as consumable, less vaginal discharge following treatment and a similar efficacy in the treatment of ectocervical precancerous lesions as compared to cryotherapy.
Thermocoagulation is a feasible approach for the treatment of precancerous lesions in LMICs. It destroys cells by causing tissue necrosis. Treatment is performed by heating the tissue to 100°C for a period of 60 s. It has an efficacy of 85%–95%. It has certain advantages like it precisely destroys the abnormal area under direct visual control, it requires shorter treatment time than cryotherapy, it does not require compressed gas and it's a lightweight device of approximately 3.6 kg that makes it easy to handle. It is being tried in certain LMICs such as Bangladesh, Malawi, Brazil, Madagascar, Nigeria, Uganda, the United Republic of Tanzania, and Zambia.
There are still limited data available from India regarding thermocoagulation and its comparison with cryotherapy as a method for treatment for low grade lesions, hence this study was planned to evaluate its safety and efficacy and to compare it with that of cryotherapy.
| > Materials and Methods|| |
The study was conducted in the Department of Obstetrics and Gynecology from September 2018 to August 2019. Ethical clearance was received from Institutional Review Board (Reg no: ECR/262/Inst/Up/2013/RR/16) Ref no: 278/Ethics/R. cell-18) Recruitment of cases was done by doing VIA testing on outpatient department (OPD) patients. Women with age between 30 and 50 years with VIA-positive cervical lesions occupying <75% of ectocervix, who were willing to participate in the study were included. Pregnant women, women <12 weeks postpartum, women who were treated for cervical cancer previously or in whom the lesion involving more than 3 quadrants of TZ or extending into vaginal wall were excluded from the study.
After exposing the cervix using a bivalve speculum, excess mucus was wiped off. Freshly prepared 5% solution of acetic acid was applied to the cervix. The cervix was inspected after 1 min for the intensity of acetowhite lesion and their borders, margins, size, and location. Test outcome was reported as either VIA positive when there was distinct, well-defined, dense (opaque, dull-or oyster-white) acetowhite areas with regular or irregular margins, close to or abutting the SCJ in the TZ or close to the external os if the SCJ is not visible.
Women with VIA positive cervical lesions were then randomly divided into two groups; Group A and Group B by computer-generated random number table. Women with VIA positive cervical lesions in Group A received cryotherapy and Group B received thermal coagulation. Before the procedure, women received an explanation about the diagnostic findings, treatment procedure, and the potential adverse effects/complications, and informed consent was obtained.
Cryotherapy was performed using nitrous oxide refrigerant with 20–24 mm ectocervical cryoprobe tip with a shallow nipple by standard double freeze technique. Cryotherapy equipment made in India (Bosco India) was used. The patient was laid in lithotomy position; Cusco speculum was inserted. Excess mucus was wiped off with cotton. Five percent acetic acid was applied to cervix for 1 min to visualize the lesion and the entire TZ. The cryoprobe tip washed with saline, was firmly applied on the cervix to ensure adequate thermal contact. Cryotherapy was done in two freeze-thaw cycles, each one consisting of a 3 min freeze followed by 5 min thaw (3 min freeze, 5 min thaw, 3 min freeze). Ice-ball formation on the cryoprobe and on the cervix during the procedure was closely observed to ensure the tip did not inadvertently contact and freeze any part of the vagina during the procedure. Once the second freeze for 3 min was completed, adequate time was allowed for thawing before removing the probe from the cervix by gentle semicircular movements. The cervix and vagina were then examined for any bleeding. Sterile sanitary pads were given to women. No local anesthesia, analgesia or sedation was used during the procedure. After the procedure, the cryoprobe was washed with cold saline and wiped off with spirit.
For thermocoagulation, the patient was laid in lithotomy position, Cusco speculum was inserted. Excess mucus was wiped off with cotton. Five percent acetic acid was applied to cervix for 1 min to visualize the lesion and the entire TZ. The probe of thermo coagulator was heated to 100°C and was applied to the cervix for a period of 60 s. If required, two or more overlapping applications of the same duration were used to cover the entire TZ of the cervix needing treatment. Out of 34 thermocoagulation procedures, in 2 patients two applications were required. Probe was then removed from the cervix gently to avoid contact of probe with any part of vagina, to avoid accidental vaginal burn. The cervix and vagina were then examined for any bleeding. No local anesthesia, analgesia, or sedation was used during the procedure. After usage, the probe was washed with cold water, dried, and heated for about 45 s at 120°C to sterilize it.
Immediately after treatment, women in both the groups were observed for any side-effects such as spotting per vaginum, heavy bleeding per vaginum, abdominal discomfort, backache, fainting, dizziness, and shivering. The abdominal discomfort felt by the patients during or immediately after procedure were assessed through visual analog score (VAS) for which patients were asked to report if they felt pain and to specify its intensity by indicating a point on a 10 cm line with 0 meaning the procedure not painful and 10 meaning it was most painful experience one could imagine. After the procedure, patients were advised to report back if they experienced high fever for more than 2 days, severe bleeding, pain, cramps, and excessive foul-smelling discharge. They were advised to avoid vaginal douche, sexual contact (or at least use of condoms) or use of tampons for 1 month after treatment. No antibiotics were routinely prescribed after treatment. All treated women were advised to come at 6 weeks and 6 months after treatment for follow-up.
At 6 weeks' follow-up, treated patients were assessed for symptoms like new onset pain abdomen, persistent vaginal discharge, new onset vaginal discharge, fever, and bleeding per vaginum and a per speculum examination was done to note the healing of cervix and the color, amount and consistency of the vaginal discharge if it was present.
At 6 months' follow-up, repeat VIA test was done and the presence for any residual VIA positive lesion was noted.
Complications during or after treatment including severe bleeding requiring hospital admission or blood transfusion, pelvic inflammatory disease, local cervical infections, and severe pain requiring hospitalization were considered as an indicator of safety. Efficacy was determined by absence of VIA positivity after 6 months of treatment.
Data were collected and analyzed in terms of frequencies, percentages, and mean standard deviation The Chi-square test was used to compare the categorical variables. The Unpaired t-test was used to compare the continuous variables. The P < 0.05 was considered significant. All the analysis was carried out on SPSS 26.0 version Chicago (Inc., USA).
| > Results|| |
A total of 667 patients attending gynecology OPD were enrolled in our study and screened for cervical cancer with VIA. Forty-three patients (6.4%, 43/667) were excluded from our study. Out of these 43, 28 patients (65.11%, 28/43) did not meet the inclusion criteria. Four out of 28 patients (14.28%, 4/28) had suspicious lesion on cervix. Twenty-four out of 28 patients (85.71%, 24/28) had VIA-positive lesion occupying more than 75% of the ectocervix. Among 667 total enrolled patients, 7 (1.04%, 7/667) denied to undergo either cryotherapy or thermocoagulation for reasons like fear of the procedure and some wanted to get consent from their spouse who were not available at the time of screening. Eight patients (1.19%, 8/667) declined to come for follow-up for reasons like residing in a far-away place or likely to be shifted to another place.
Out of 34 cryotherapy procedures, in 5 patients, the procedure was interrupted. During 3 procedures, the interruption was due to leakage of gas from the equipment. In 2 patients, cryotherapy could not be done because of empty gas cylinder, these patients were advised to come on the next visit. There was no interruption during 34 thermocoagulation procedures.
Out of 34 patients treated with cryotherapy, 1 patient lost to follow-up at 6 weeks and in 2 patients (5.88%, 2/34) intervention was discontinued as they conceived. Remaining all 31 patients who were treated with cryotherapy came for follow-up at 6 months. Among 34 patients treated with thermocoagulation, 2 patients (5.88%, 2/34) lost to follow-up at 6 weeks. Out of remaining 32 patients treated with thermocoagulation, 1 lost to follow-up at 6 months. Therefore at 6 months follow up each arm had 31 patients [Figure 1]. Majority of the patients in our study belonged to the age group of 30-39 years (79.40%) with the mean age of 35.59 ± 5.34 years, 57.35% had parity of up-to 3–5 and majority were housewives (95.59%). Most of them had attained some formal education (94.12%). In our study, the mean age of the patient at which they have attained menarche was 13.33 ± 0.73 years, mean age of consummation was 20.63 ± 1.84 years and mean age at first delivery was 21.89 ± 1.86 years. Majority (72.06%) of them had used contraception among which barrier method was the most common (42.65%). There was no statistical difference in the distribution of different demographic variables between two groups, thus, the study was well randomized as shown in [Table 1].
|Figure 1: Enrollment of subjects, their allocation to treatment (Cryotherapy and thermocoagulation) and their follow up at 6 weeks and 6 months|
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Majority of the patients presented in OPD with the complaint of discharge per vaginum (68, 67.67%) followed by backache (28, 41.18%) and pain abdomen (26, 38.23%). There was no statistical difference in the distribution of chief complaints between two groups as shown in [Table 2]. [Table 3] shows comparison of immediate side effects between two groups. In Group A, 14 patients (41.18%) were asymptomatic during and immediate post procedure. Eight patients (23.53%) had backache. Six patients (17.65%) complained of pain abdomen. The mean VAS score for pain abdomen in Group A was 3.33+-1.03 (median = 3). Three patients (8.82%) complained of shivering. Two patients (5.88%) had both shivering and backache. One patient complained of spotting per vaginum.
In Group B, 29 patients (85.30%) were asymptomatic during and immediate post procedure. Three patients (8.82%) had backache. Two patients (5.88%) complained of pain abdomen. The mean VAS score for pain abdomen in Group B was 2.50 ± 0.71 (median = 2.5).
None of the patients in either group had spotting per vaginum, heavy bleeding PV, dizziness, or an episode of fainting.
Patients in Group B (85.30%) were significantly asymptomatic post procedure than Group A (41.18%); P = 0.008. In Group A, 10 patients (32.35%) were asymptomatic at 6 weeks after cryotherapy. Sixteen patients (51.61%) had persistent discharge PV. Two patients (6.45%) had new-onset discharge PV. One patient had pain abdomen. One patient complained of bleeding PV and 1 patient had a complaint of fever.
In Group B, 20 patients (62.50%) were asymptomatic at 6 weeks after thermocoagulation. Nine patients (28.13%) had persistent discharge PV. One patient (3.12%) had new onset discharge PV. One patient had pain abdomen and 1 patient had a complaint of fever. At 6 weeks follow up, patients in Group B (62.50%) were significantly asymptomatic as compared to Group A (32.35%); P = 0.016 as shown in [Table 4].
Out of 34 patients who were treated with cryotherapy, 3 patients returned to OPD within 2 weeks' post procedure with a complaint of profuse watery discharge PV. None of them complained of foul-smelling nature of the discharge or associated pain abdomen or fever. None of them gave a history of sexual contact post procedure. On per speculum examination, nothing abnormal findings were found and the discharge was found to be procedure related. These patients were counseled and were advised to come for follow-up at 6 weeks.
Out of 34 patients who were treated with thermocoagulation, 1 patient returned at 2 weeks' postprocedure with the complaint of foul-smelling discharge PV and abdominal discomfort. No history of sexual contact was elicited. On per speculum examination, the cervix was unhealthy and yellowish foul-smelling discharge was present. Antibiotics were prescribed and after on week follow-up, she was absolutely fine.
In our study, a total of 46 patients presented to gynecology OPD with vaginal discharge as chief complaint, 24 subjects in Group A and 22 in Group B. Out of 24 patients in Group A, 16 patients (66.66%, 16/24) complained of persistent discharge per vaginum at 6 weeks' follow-up as shown in [Figure 2]. None of them complained of foul-smelling discharge or associated pain abdomen and fever. Two patients gave a history of sexual contact within 4 weeks of procedure. Eleven out of 16 patients gave a history of on and off discharge PV and the mean duration of the vaginal discharge was 4 days. On per speculum examination of these 16 patients, 13 had non-foul smelling scanty thick mucoid discharge, 2 had non foul-smelling watery discharge and 1 had scanty curdy white discharge. All 16 patients who had received cryotherapy had healed cervix at 6 weeks' follow-up.
|Figure 2: Persistent Vaginal discharge in treated subjects at 6 weeks follow up|
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Out of 22 patients in Group B, 9 patients (40.90%, 9/22) complained of persistent discharge per vaginum at 6 weeks' follow-up. None of them complained of foul-smelling discharge or associated pain abdomen or fever. One patient had a history of sexual contact within 4 weeks' post procedure. Seven out of 9 patients had on and off discharge PV and the mean duration of the vaginal discharge was 3 days on per speculum examination of these 9 patients, 8 patients had non foul smelling scanty thick mucoid discharge and 1 had non foul-smelling watery discharge. All 9 patients had completely healed cervix. The efficacy of both the groups was similar in our study. The efficacy of thermocoagulation and cryotherapy was 93.54% and 90.32% respectively. There was no statistical difference in the efficacy between thermocoagulation and cryotherapy (P = 0.641) as shown in [Table 5].
|Table 5: Comparison of assessment for efficacy after 6 months with visual inspection with acetic acid between two groups|
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| > Discussion|| |
In our study, 624 cases were screened with VIA test. In low resource setting, it is generally recommended that screening should be initiated at age of 30 years to capture maximum cases of precancerous lesions with limited resources so in our study we also included patients attending OPD of more than 30 years of age. In our study, majority (54, 79.40%) of the patients in both the groups belonged to the age group of 30–39 years and rest belonged to age group of 40–50 years. It was comparable with Patil et al.'s and Mishra et al.'s study in which the age-wise distribution of the cases was more common in the age group of 30–40 years and 31–40 years, respectively. The mean age group (35.59 years) was comparable with the mean age (37.2 years) of Hasanzadeh et al.'s study. The reason for maximum patients in our study from 30 to 40 years is because maximum patients attending the Gynecology OPD is from the same age group and VIA positive patients were screened from OPD population.
Most common presenting complaint of women in both the groups was vaginal discharge (46, 67.64%) which was comparable to Patil et al. study where it was 59% but lower than the Bhalerao et al. study where 71% had vaginal discharge as chief complaint. The reason for the high percentage of women with discharge per vaginum as chief complaint in Bhalero et al. study was that only those women were included in their study who had unhealthy cervix. The next common complaints were backache (41.18%) and pain abdomen (38.23%) which was higher than that in Bhalero et al. studies where only 22 women (11%) and 13 women (2.67%) had complaint of pain abdomen, respectively. Out of 624 women screened with VIA, 68 were VIA positive. The VIA-positive rate in our study was 10.89% which was comparable with the VIA positive rates of 10.75%, 16.2% of Usha Rani et al. and Akinola et al. studies but lower than the 50% VIA-positive rate of Hasanzadeh et al. study. The reason for this high VIA positivity rate was that only symptomatic patients with a complaint of recurrent vaginal discharge, postcoital/intermenstrual or postmenopausal bleeding were enrolled in their study.
For the implementation of any procedure as treatment modality, safety is always of much concern. Safety of a treatment modality is decided by the absence or minimum side effects during and after treatment and also the absence of adverse effects requiring hospitalization.
There is recent focus towards thermocoagulation in view of availability of light equipment which is portable and procedure takes less time so patients have less discomfort. Also, in follow-up, it is found that thermocoagulation produces less vaginal discharge in comparison to cryotherapy.
In our study, both the procedures were found to be overall safe but thermocoagulation was better in terms of producing less side effects during procedure, immediately after the procedure and at 6 weeks' follow-up.
None of the patients in our study in either group had heavy bleeding PV, dizziness, or fainting attack thus indicating both the procedures to be safe which was comparable with Dolman et al. meta-analysis study in which out of 8 studies, 5 studies have reported the absence of side effects during thermocoagulation treatment and 2 have reported absence of adverse effects post cryotherapy treatment and Luciani et al. and Phongsavan et al. studies in which no adverse complaints of patients were seen during or after the cryotherapy procedure. However, the patients in thermocoagulation group (85.30%) were significantly and statistically more asymptomatic than cryotherapy (41.18%) group during and immediate post procedure (P < 0.001). The side effects during and after treatment with thermocoagulation were also less than cryotherapy group but not statistically significant. In cryotherapy group, 6 patients (17.65%) had abdominal pain, 8 (23.53%) had backache whereas in thermocoagulation group 2 patients (5.88%) had pain abdomen and 3 patients (8.82%) had backache.
More complaints of backache and pain abdominal pain in cryotherapy group as compared to thermocoagulation group were found in our study. This may be due to long procedure time of cryotherapy which requires freeze-thaw-freeze technique requiring 11 min while thermocoagulation is just a 60 s procedure.
In our study, more patients in thermocoagulation group were asymptomatic (62.50%) and had comparatively less symptoms than cryotherapy group (32.25%) at 6 weeks' follow-up. In cryotherapy group, 18 patients (58.06%) complained of discharge per vaginum which was higher than the rates found in previous studies like Luciani et al. in which 5.8% women had discharge PV at 4–6 weeks' follow-up. One patient (3.22%) had pain abdomen, 1 (3.22%) had bleeding PV and 1 woman (3.22%) had fever at 6 weeks' follow-up. In thermocoagulation group, 10 (31.25%) had discharge per vaginum, 1 (3.12%) had new onset pain abdomen and 1 patient had fever at 6 weeks but no patient had bleeding PV. In our study, reason for this increased percentage of women with persistent discharge PV and pain abdomen at 6 weeks' follow-up may be because our study population was already symptomatic one rather than pure screening population.
The efficacy of a treatment modality is the ability to produce a desired result. More efficacious the procedure is, better is the modality. Thermocoagulation (cold coagulation) has been available as an ablative treatment modality for precancerous lesions since 1980s, but it could not gain popularity for many decades. However, resurgence of this procedure occurred in last decade.
A recent meta-analysis by Dolman et al. which included studies mainly done in industrialized countries have shown that thermocoagulation is as effective as other ablative methods such as cryotherapy and also there are lesser side effects and lesser logistic problems in comparison to cryotherapy. Thermocoagulation may be particularly more beneficial for LMICs in view of lesser logistic problems. The WHO also recommends a definitive screen and treat method for treatment of cervical precancerous lesions for LMICs for which thermocoagulation proves to be a better ablative method which is both safer and more effective than methods which are currently available. However, no substantial and robust data is available from developing countries pertaining to its safety and efficacy.
Although there are various studies which have taken cytology for follow-up, only few studies have taken the absence of CIN as definition of cure. We have done the procedure on the VIA positive cases, so VIA negativity at 6 months' follow-up was taken as efficacy. It would have been better to follow the patients at 1 year but we had followed at 6 months due to time constraints and this is also the limitation of our study. In our study, the efficacy of both the procedures was similar. The efficacy of thermocoagulation was 93.54% which was comparable with the efficacies of thermal ablation in the studies of Campbell et al. and Oga et al. that is 94% and 83.6%, respectively. The efficacy of cryotherapy was 90.32% which was comparable with the efficacies of cryotherapy in the studies of Phongsavan et al. and Sankaranarayanan et al. that is 88.3% and 86.3%, respectively.
Although the gold standard is histologically confirmed CIN cases we chose VIA positive for participant selection for ablative treatment which is according to WHO recommendation of same day screen and treat policy for LMICs. This strategy prevents lost to follow-up. In other studies, like Manuela et al., their primary screening modality was HPV testing and VIA was done in HPV positive cases. We did not incorporate HPV testing in our study because of financial constraints. Since VIA has a sensitivity of 100%, so VIA positivity was taken for participant selection for ablative procedure. For follow-up, we took VIA negative as cure definition as VIA testing has negative predictive value (NPV) of 100%.
There was no statistical signicant difference in efficacy of thermocoagulation and cryotherapy for VIA positive cervical lesions. However, thermocagulation was more comfortable for patients and had lesser side effects immediate post procedure and at 6 weeks.
Thermocoagulation is a better treatment modality than cryotherapy may not be in terms of efficacy but definitely better in terms of patient comfort.
I sincerely acknowledge my thanks to my patients for participation in the study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| > References|| |
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCON estimates of incidence and mortality worldwide for 36 cancers in 85 countries. CA Cancer J Clin 2018;68:394-424.
Awasthy S. Epidemiology of cervical cancer with special focus on India. Int J Womens Health 2015;7:405-14.
Santesso N, Mustafa RA, Schünemann HJ, Arbyn M, Blumenthal PD. Joanna Cain World Health Organization Guidelines for treatment of cervical intraepithelial neoplasia 2-3 and screen-and-treat strategies to prevent cervical cancer. Int J Gynaecol Obstet 2016;132:252-8. PMID: 26868062 DOI: 10.1016/j.ijgo.2015.07.038.
Bobdey S, Sathwara J, Jain A, Balasubramaniam G. Burden of cervical cancer and role of screening in India. Indian J Med Paediatr Oncol 2016;37:278-85.
] [Full text]
Castle PE. Treatment of cervical intraepithelial lesions. Int J Gynecol Obstet 2017;138:22-5.
Patil K, Durdi G, Lakshmi KS, Swamy MK. Comparison of diagnostic efficacy of visual inspection of cervix with acetic acid and Pap smear for prevention of cervical cancer: Is VIA Superseding Pap smear? Smear J South Asian Federation Obstet Gynaecol 2011;3:131-4.
Mishra GA, Pimple SA, Gupta S. Cervical cancer screening in low resource settings: Cytology versus HPV triage for VIA positive women. Int J Prev Med 2019;10:138.
] [Full text]
Hasanzadeh M, Esmaeili H, Tabaee S, Samadi F. Evaluation of visual inspection with acetic acid as a feasible screening test for cervical neoplasia. J Obstet Gynaecol Res 2011;37:18026.
Bhalaero A, kulkarni S, Guke S, Kawathalkara A, Joshi S. Correlation of pap smear, colposcopy and histopathology in woman with unhealthy cervix. J South Asian Feder Obst Gynae 2012;4:97-8.
Poli UR, Bidinger PD, Gowrishankar S. Visual inspection with acetic acid (VIA) screening program: 7 years experience in early detection of cervical cancer and pre-cancers in rural South India. Indian J Community Med 2015;40:203-7.
] [Full text]
Akinola OI, Fabamwo AO, Oshodi YA, Banjo AA, Odusanya O, Gbadegesin A, et al.
Efficacy of visual inspection of the cervix using acetic acid in cervical cancer screening: A comparison with cervical cytology. J Obstet Gynaecol 2007;27:703-5.
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.
Luciani S, Gonzales M, Munoz S, Jeronimo J, Robles S. Effectiveness of cryotherapy treatment for cervical intraepithelial neoplasia. Int J Gynaecol Obstet 2008;101:172-7.
Phongsavan K, Phengsavanh A, Wahlström R, Marions L. Women's perception of cervical cancer and its prevention in rural Laos. Int J Gynecol Cancer 2010;20:821-6.
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.
Oga EA, Brown JP, Brown C, Dareng E, Adekanmbi V, Odutola M, et al.
Recurrence of cervical intraepithelial lesions after thermo-coagulation in HIV-positive and HIV-negative Nigerian women. BMC Womens Health 2016;16:25.
Sankaranarayanan R, Rajkumar R, Esmy PO, Fayette JM, Shanthakumary S, Frappart L, et al.
Effectiveness, safety and acceptability of 'see and treat' with cryotherapy by nurses in a cervical screening study in India. Br J Cancer 2007;96:738-43.
Viviano M, Kenfack B, Catarino R, Tincho E, Temogne L, Benski AC, et al
. Feasibility of thermocoagulation in screen-and-treat approach for the treatment of cervical precancerous lesion in sub-Saharan Africa. BMC Women Health 2017;17:2.
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]