Comparison of thermal ablation and cryotherapy for treatment of symptomatic cervical ectopy

Rationale: There are very few studies on cervical ectopy though it contributes significantly to multiple OPD visits of gynaecological patients, chronic ill health and recurrence. Thermal ablation has been used for treatment of CIN, however, there are no studies on thermal ablation for treatment of symptomatic cervical ectopy.

Aim: To compare thermal ablation and cryotherapy techniques for treatment of symptomatic cervical ectopy in terms of efficacy, feasibility, acceptability and safety.

Objectives

Primary: To compare efficacy of thermal ablation and cryotherapy techniques in treatment of symptomatic cervical ectopy.

Secondary:

1)    To compare feasibility of two techniques.

2)     To compare acceptability and safety of two techniques.

3)    To know proportion of women having cervical intraepithelial neoplasia (CIN) in symptomatic cervical ectopy.

Study design: Non inferiority randomized controlled trial

Time frame: November 2019 to April 2021

Inclusion criteria

Women of reproductive age group (18-49 years) having symptoms of persistent vaginal discharge, backache, intermenstrual bleeding, postcoital bleeding and showing cervical ectopy on per-speculum examination.

Exclusion criteria

• Cervical intraepithelial neoplasia (CIN)

• Acute cervicitis

• Nulliparity

• Pregnancy

• Pelvic inflammatory disease (PID)

• Women on hormonal contraception

Sample size: It is a pilot study so sample of convenience will be taken. Total 60 patients will be taken, 30 in each of the two group.

Methodology: After applying the inclusion and exclusion criteria, study subjects will be recruited and subjected to detailed history taking, medical and gynaecological examination as per case record form (Annexure-II). All the patients would be screened by Pap smear/VIA -VILI for carcinoma cervix. Patients with positive screen will be further evaluated by colposcopy and biopsy for presence of CIN.

Study population will include

1. All screen negative patients

2. Screen positive patients without CIN

Subjects will be randomly assigned to Group A and Group B.

Group A: Patients would be treated with thermal ablation.

Group B: Patients would be treated with cryotherapy.

Outcome measures

Primary outcome:

1. Efficacy

a)    Post-procedure, remission of symptoms at 8 and 12 weeks in following groups:-

i)  0-25 %

ii) 25-50 %

iii) 50-75 %

iv) 75-100%

b)    Recurrence of symptoms at 12 weeks

c)    Cure rate (healing of lesion on per speculum examination)

Partial cure and complete cure at 8 and 12 weeks

Secondary outcomes

1. Feasibility

·         Number of cases where procedure could not be done

·         Difficulties encountered

2. Acceptability and Safety

·         Pain and discomfort during or after the procedure

·         Bleeding during or after the procedure

·         Any reaction such as fainting, dizziness, nausea during the procedure

Statistical analysis

Since it is a parallel study, it is being done on a very small sample size compared to calculated sample size. No test of significance can be applied.

Data will be recorded in terms of

1)    Efficacy

a) Remission of symptoms at 8 and 12 weeks in 4 categories namely

i) 0-25%

ii) 25-50%

iii) 50-75%

iv) 75-100% (quantitative data, ANOVA test)

b) Recurrence of symptoms at 12 weeks (qualitative data/ chi square test)

c) Cure Rate (healing of lesion on per speculum examination)

i) Partial cure (<50% and >50%) and Complete Cure at 8 and 12 weeks (quantitative data, ANOVA test)

2)    Feasibility (qualitative data/ chi square test)

Number of cases where procedure could not be done

Difficulties encountered

3)    Acceptability and Safety

a)   Pain and discomfort during or after the procedure (according to visual analog scale)

b)   Bleeding during or after the procedure (qualitative data/ chi square test)

c)   Any reaction such as fainting, dizziness, nausea during the procedure (qualitative data/ chi square test)