Randomised Prospective Comparative Study on the Efficacy of Sharma Jhawer’s Operation with Lord’s Plication and Jabouley’s Operation in the Treatment of Primary Vaginal Hydrocele

AIM AND OBJECTIVES: 1. To study the various clinical presentations of primary vaginal hydrocele. 2. To compare the efficacy of Sharma & Jhawer’s surgery Vs Lord’s plication for small sized uncomplicated primary vaginal hydrocele (< 7cms) 3. To compare the efficacy of Sharma & Jhawer’s surgery Vs Jaboulay’s for medium sized uncomplicated primary vaginal hydrocele (> 7cms and < 14cms) 4. To assess postoperative complications, morbidity associated with the above surgical procedures. 5. To analyze the simplicity, expenditure & effectiveness of the three procedures. Design of Study: Randomized prospective comparative Study. Simple Randomization. Sample Size: Epi info software, Time taken to revert back to normal taken as mean, SD 1.7 and 1.36 for respective procedure, Confidence interval 95% and Power 80%, 23 rounder off to in each group. Duration: 2 Years (June 2016 to May 2018). COMPARTMENTS OF THE STUDY: The study was done in two compartments to assess the efficacy of Sharma and Jhawer’s for both small and medium sized primary vaginal hydrocele. • Hydrocele size < 7cms diameter are considered as small sized hydrocele and are included in compartment I. • In compartment I Sharma & Jhawer’s technique was compared with the Lord’s Plication procedure for small sized hydrocele. • Hydrocele size > 7 cms and < 14 cms diameter are considered as medium sized hydrocele and are included in compartment II. • In compartment II Sharma & Jhawer’s technique was compared with Jaboulay’s procedure for medium sized hydrocele. • Size measured using Vernier’s Caliper. STATISTICAL ANALYSIS: • Data entered into Microsoft Excel (Windows 7 ; Version 2007) • Analyses done using the Statistical Package for Social Sciences (SPSS) for Windows software (trial version 22.0; SPSS Inc, Chicago). • Descriptive statistics: Mean and Standard Deviation (SD) for continuous variables, Frequencies and percentages will be calculated for categorical variable. • Comparison between groups analyzed using: Chi square test of independence and Fischer’s test for categorical variables, Unpaired T test for quantitative variables. • Bar charts and Pie charts for visual representation of analysed data. • Level of significance set at 0.05. STUDY POPULATION: All patients with primary vaginal hydrocele satisfying eligibility criteria admitted for surgery in the surgical ward of Government Rajaji Hospital / Madurai Medical College during the study period of June 2016 to May 2018. ELIGIBILITY CRITERIA: Inclusion Criteria: 1. Solitary swelling in the scrotum incorporating the testis. 2. The swelling should be positive for trans-illumination. 3. It should be possible to get above the swelling at the root of scrotum. 4. Hydrocele size < 7cms diameter are considered as small sized hydrocele and are included in compartment I. 5. Hydrocele size between 7 to 14 cms diameter are considered as medium sized hydrocele and are included in compartment II. 6. In a patient with bilateral hydrocele each hydrocele will be considered as a separate case in this study. Exclusion Criteria: 1. Swelling arising from the skin of scrotum. 2. Solitary swelling in the scrotum which is separate from the testis. 3. Diffuse swelling in the scrotum incorporating the testis but negative on trans-illumination. (All secondary long standing complicated hydrocele are ruled out of the study). 4. Swelling in which there is associated impulse on coughing and reducibility. END POINT: • The primary end point was once the testis returned back to normal size. • The secondary end points were hematoma, infection and wound disruption. • So the follow up period was different for every patient • Which varied from 8 to 28 days. CONCLUSION: Between the three procedures analyzed, in our setting Sharma and Jhawer’s minimal dissection technique had statistically significant. lesser complications, lesser time to revert back to normal and cost effective than Lord’s plication for small sized primary vaginal hydrocele and Jaboulay’s operation for medium sized primary vaginal hydrocele. Hence Sharma Jhawer’s is most beneficial for the patient and with least complications for treating small and medium sized primary vaginal hydrocele. Further multi centric randomized trials and meta-analysis are needed to emphasize the significance of the results in our study.