STRUCTURED ABSTRACTIntroductionPelvic radiotherapy RT plays an significant role in management of gynaecological

STRUCTURED ABSTRACTIntroductionPelvic radiotherapy (RT) plays an significant role in management of gynaecological malignancies. Apart from the commonly addressed acute side effects, late side effects like vaginal stenosis (VS), remains an unaddressed problem. In this study, we seek to assess the efficacy of vaginal dilator use in a set of patients with cervical and endometrial carcinoma treated with pelvic radiotherapy.ObjectivesTo assess the efficacy of vaginal dilator use post radiotherapy in cervical and endometrial cancer patients and the adherence to vaginal dilator use. Also to assess the relationship of vaginal stenosis with dose of chemotherapy received.Methods Patients with biopsy proven endometrial and cervical malignancy, who had undergone pelvic radiotherapy from December 2017 to June 2019 were analysed. The required sample size was 70 , with 35 patients in each arm (VD users and VD Non users).All patients were recommended regular VD use 6 weeks post radiotherapy. The efficacy and adherence to vaginal dilator use was investigated every 3 monthly for a total of 1 year. LENT SOMA scoring system was used to grade vaginal stenosis. Data analysis was done using Chi square test and Fischer exact test. ResultsAmong 42 patients analysed , 22 patients not using vaginal dilators were assigned to the control group and 20 patients using the dilators were assigned to test group. 55% versus 22.7% using vaginal dilators maintained pre radiotherapy vaginal size on 1 year follow up (p= 0.024). Adherence was highest during the first 6 months following which it declined over a period of 1 year.ConclusionRegular vaginal dilator use post radiotherapy is effective in preventing vaginal stenosis and thus improves the quality of life. This study highlights the need for counselling patients regarding preventive strategies and also need for regular posttreatment surveillance. Continued follow up is required to evaluate long term efficacy. AIMS AND OBJECTIVESAimTo assess the efficacy of vaginal dilator use post radiotherapy in cervical and endometrial cancer patients in preventing vaginal stenosis.Primary Objective: To assess the efficacy of vaginal dilator use post radiotherapy in cervical and endometrial cancer patients.Secondary Objective: To determine the adherence to vaginal dilator use. To assess relationship of vaginal stenosis with dose of chemotherapy received.. METHODOLOGYStudy design : Cohort studyStudy setting : Conducted in Department of Radiotherapy, Amala Institute of Medical sciencesStudy Period:- one and half yearsStudy population :- Patients with biopsy proven endometrial and cervical carcinoma who underwent pelvic radiotherapy in the Department of Radiation Oncology, Amala Institute of medical sciences Sample size – n=[z〖1-α⁄2 √(2p(1-p) )+z_(1-β)〗^ {p_1 (1-p_1 )+p_(2 ) (1-p_2 }]p_(1 )- p_2α=0.05= 1.96p_1=Incidence of returning to pre RT vaginal size after using VD = 71% (13)p_2 = Incidence of vaginal stenosis after pelvic radiotherapy-= 38% (5)Power- 80%n = 35 in each armInclusion criteria- Cervical carcinoma (FIGO Stage – IA to IVA) Endometrial carcinoma (FIGO Stage IB Grade III, FIGO Stage II) Histology: squamous cell carcinoma, adenocarcinoma Age group- 20- 70yrs Performance score- ECOG 1Exclusion criteria- Prior pelvic radiation Recurrence of disease during follow up period.MATERIALS AND METHODSPatients with biopsy proven endometrial and cervical carcinoma who underwent pelvic radiotherapy in the Department of Radiation Oncology, Amala Institute or Medical Sciences from the period of December 2017 to June 2019 were prospectively included.All patients provided written informed consent and the study was approved by the ethics committee. Patients meeting the inclusion criteria underwent Computed Tomography (CT) simulation with intravenous contrast medium. 3mm slice thickness images were obtained and transferred to Treatment Planning System. The GTV, CTV, PTV, OAR were delineated on the CT images. For post hysterectomy endometrial carcinoma/ cervical carcinoma patients, the CTV will include the regional nodes, parametrial/ paravaginal tissue, and upper half of vagina as per Small et al guidelines. (1) The regional lymph nodes included were bilateral obturator, external and internal iliac, common iliac nodes. For cervical cancer patients & endometrial carcinoma patients with involvement of cervix, the presacral region was also included extending to S3 to cover presacral lymph nodes and uterosacral ligaments. For intact cervical carcinoma, the CTV included the entire GTV, the entire cervix (if not included in GTV), uterus, entire parametrium including ovaries, the mesorectum of uterosacral ligaments and the upper half of vagina. (2) The upper two- third of vagina was included if the upper vagina was involved and the entire vagina was included if there was extensive involvement of vagina. The lymph nodes were contoured as per Small et al guideline.The total prescribed dose for endometrial carcinoma was 45Gy in 25 fractions. The total prescribed dose for cervical carcinoma 50.4Gy in 28 fractions along with concurrent Cisplatin chemotherapy (40mg/m2).The OAR’s were delineated as per RTOG Female pelvis normal structure contouring guidelines and included bladder, rectum, bowel bag and femoral heads. This was followed by HDR brachytherapy which included:- Vaginal brachytherapy for endometrial carcinoma, post operative cervical carcinoma – Total prescribed dose – 18Gy to to 0.5cm depth of upper 2/3rd of vagina(600cGy x 3) Intracavitary brachytherapy for intact carcinoma cervix- Total prescribed dose – 21Gy to point A (700cGy x 3) Cervical carcinoma patients who were not ideal candidates for brachytherapy were given external boost dose of 10- 16Gy.All patients were assessed at 6 weeks follow up and grade of vaginal stenosis recorded. All patients were counselled regarding vaginal hygiene, advantages of usage of vaginal dilators. Three types of dilators were used small , medium and large with diameter of 2cm, 2.5cm and 3cm. The length of the dilator was 14cm It was advised to use the prescribed dilator 3 times a week for 5-10 minutes per application as per the best practice guidelines from the National Forum of Gynecological oncology nurses, 2005. The dilator should be gradually inserted into the vagina in a circulatory motion to clear adhesions. Patients were also counselled regarding proper maintenance of the dilator.Patients using the dilators were assigned to test group and the non users were assigned to the control group. Surveillance and follow upAssessment included clinical history , general examination, pelvic examination at 3monthly intervals till 1 year. Grading of vaginal stenosis was assessed using LENT SOMA grading system. Total adherence was calculated as follows:-Total number of times patient used VD in given time period÷Maximum number of times of VD use in given time periodPercent adherence was calculated from 1st quarter to 4th quarter. Percent adherence = number of times each patient used the VD in each quarter ( 3 times per week x 13 weeks). Efficacy was calculated on the basis of whether pre RT VD size is maintained at the end of follow up.In the event of disease recurrence or metastatic disease, the grade of VS on the last follow up was considered. AlgorithmEndometrial/ cervical carcinoma patients meeting inclusion criteriaObtaining informed consentPre RT counselling of VD useTreatment- EBRT +/ BrachytherapyAssessing size of vaginal dilator and patient counselling Initiation of regular VD use 6 weeks post RT.Patients maintain a diary to keep track of their VD use.Monthly reminder phone calls.Follow up assessment of VS grade, current VD size at 3months, 6 months, 9months, 1 year Calculate adherence to treatment on each follow upData analysisSTASTISTICAL ANALYSISData analysis was done using Chi square test and Fischer exact test. Statistical analyses were done using SPSS software (version 24). RESULTS42 patients who met the inclusion criteria were analysed at Department of Radiation Oncology, Amala Hospital from the period of December 2017 to June 2019. 20 patients using vaginal dilators were assigned to the test group and 22 patients who refused to use vaginal dilators were assigned to control group. 2 patients in the test group died during the period of follow up and 3 patients (1 in the test group and 2 in the control group had disease recurrence)Patient, tumour and treatment characteristics Test group(n = 20) Control group (n=22) Total AGE Mean age 56 60 PRIMARY TUMOUR SITE Cervix 13 17 30 Endomterium 7 5 12 FIGO STAGE (Cervix) Ib 3 0 3 II a 3 2 5 II b 6 8 14 IIIa 0 2 2 IIIb 1 4 5 Iva 0 1 1 All stages 30 FIGO STAGE (Endometrium) Ib 5 3 8 II 2 2 4 III 0 IV 0 All stages 12 HISTOLOGY Squamous cell carcinoma 11 14 25 Adenocarcinoma 9 8 17 TREATMENT TECHNIQUE IMRT alone 0 3 3 IMRT + VBT 12 6 18 IMRT + ICRT 8 13 21 MENOPAUSE Premenopausal 4 3 7 Postmenopause 16 19 35 SURGERY Radical Hysterectomy 12 7 19 No surgery 8 15 23 Study profile 42 patients included 6 weeks n=20 assigned to use n= 22 non users VD (test group) ( control group )Follow up assessment3 months 20 patients 22 patients 6months 20 patients 22 patients 9months 20 patients 22 patients12 months 20 patients 22 patients 2 died, 1 recurrence 2 disease recurrenceFinal analysis 20 22 Presenting complaints28 patients (66.6%) had presented with complaints of bleeding per vaginum, 6 patients (14.2%) with history of spotting per vaginum, 16 patients (38%) with history of white discharge per vaginum and 4 patients (9%) with history of lower abdominal pain. Figure: Distribution of patients as per presenting complaints Figure : -Distribution of patients as per histological diagnosis Efficacy of vaginal dilator useEfficacy of vaginal dilator use was calculated for all 20 patients in the test group. All 20 patients were followed up till 9 months. Only 12 patients were followed up till 1 year. 2 patients died during follow up period , one due to comorbid illness and one due to progressive disease.Table : Assessment of vaginal stenosis 6 weeks post radiotherapy LENT SOMA grade of VS Total P valueChi square test Control group Test group .0 19 18 37 0.5171.0 2 2 4 2.0 0 0 0 3.0 1 0 1 4.0 0 0 0 Total 22 20 42 Figure : Efficacy of vaginal dilator at 3 months follow up Vaginal dilators were effective for 80% of VD users compared to 45% non users (p=0.028) Figure : Efficacy of vaginal dilator at 6 months follow up Vaginal dilators were effective for 60% of VD users compared to 27% non users (p=0.011)Figure: Efficacy of vaginal dilator at 9 months follow up Vaginal dilators were effective for 60% of VD users compared to 20% non users (p=0.007)Figure : Efficacy of vaginal dilator at 12 months follow up Vaginal dilators were effective for 58% of VD users compared to 16.6% non users (p=0.066)Figure : Total vaginal dilator efficacy

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