Dissections INTERVENTIONAL

19 May 2009
Evidence-based Medicine for Surgeons

Sclerotherapy for hydrocele revisited: a prospective randomised study

Authors: Agrawal MS, Yadav H, Upadhyay A, et al
Journal: Indian J Surgery 2009; 71: 23-28
Centre: S N Medical College, Agra, India
Operative treatment has been the gold standard in the management of patients with primary
hydrocele of the tunica vaginalis testis. However, it is invasive and associated with high morbidity
BACKGROUND and prolonged convalescence. Sclerotherapy, after evacuation of the hydrocele, has been
recommended as a simpler, less invasive option, but its efficacy has not been clearly established.
Doubts persist about the best agent to use.
Authors' claim(s): “...Five percent phenol is a better sclerosant than 1%
RESEARCH QUESTION polidocanol and is as efficacious as operative treatment [of primary, vaginal
hydrocele], with lesser morbidity and similar safety profile.”
Population
Patients presenting with unilateral, IN SUMMARY
primary, vaginal hydrocele.
Outcome comparison between the three types of treatment
Indicator variable
Surgical treatment 5% phenol 1% polidocanol
Sclerotherapy (using 5% phenol or sclerotherapy sclerotherapy
1% polidocanol).
Number randomized 28 29 29
Outcome variable Hydrocele volume (mean) 243ml 196ml 201ml
Primary: Cure of the hydrocele. Cure rate 100.00% 96.50% 51.70% *
Secondary: Postoperative pain,
edema, hematoma, wound Pain score - 1 week (VAS) 64 * 14.5 10.1
infection; duration of hospital stay Pain score - 1 month (VAS) 10.6 * 1.8 1.3
and time taken to return to work.
Wound infection 7.10% * 0 0
Comparison
Hospital stay (hours) 9.7 * 1.8 1.5
Surgical treatment (Jaboulay's
technique). Return to work (days) 12.7 * 1.3 1.1
* = Statistically significant difference
VAS = visual analogue scale

THE TISSUE REPORT

The value of sclerotherapy as the primary treatment for vaginal hydrocele continues to be a subject of debate. Although the
authors have attempted to settle this issue with a RCT, there are several areas of discomfort in this study.
The authors provide no details about the method of randomization. When you look at the volumes of the hydrocele, the
surgical group had a significantly larger amount. This should not have happened if the process of randomization was
proper. There is no mention about the statistical significance of this difference.
Details regarding recruitment into the study are skimpy.
Transillumination (an arguably subjective test) was the only criterion for detection of primary hydrocele and recurrence
after treatment. Ultrasound evaluation of the scrotum would have been more appropriate.
Still, something to take note of in view of the figures reported for the safety, efficacy and economics of 5% phenol
sclerotherapy.

EBM-O-METER
Evidence level Overall rating Bias levels
Double blind RCT Sampling
Randomized controlled trial (RCT) Comparison
Trash Swiss Safe News-
Prospective cohort study - not randomized cheese worthy Measurement
Life's too Holds water
short for this Full of holes “Just do it”
Case controlled study
Interestingl | Novel l | Feasible l
Case series - retrospective  Ethical l | Resource saving l

The devil is in the details (more on the paper) ... 

© Dr Arjun Rajagopalan
 SAMPLING
Sample type Inclusion criteria Exclusion criteria Final score card
Simple random Unilateral, primary Secondary hydrocele Surgery Phenol Polidocanol
vaginal hydrocele  (trauma,
Stratified random Target ? ? ?
malignancy,
Cluster infection)  Accessible ? ? ?
Communicating
Consecutive hydrocele  Intended ? ? ?
Convenience Age < 12 years  Drop outs ? ? ?
Previous
Judgmental intervention  Study 28 29 29

 = Reasonable | ? = Arguable |  = Questionable

A priori sample size calculation not done
Duration of the study: Not specified

Sampling bias: The authors have not calculated a sample size a priori. The process of recruitment into the study
are glossed over. No details are provided of drop outs, if any.

COMPARISON
Randomized Case-control Non-random Historical None

Controls - details
Allocation details Sclerotherapy was performed on outpatient basis with 2% lignocaine using a 24 gauge needle
and 5 ml syringe. Scrotal puncture was done with an 18 gauge intravenous cannula, which
was connected to an intravenous line. Hydrocele fluid was drained by gravity and collected in
a graduated container. The scrotum was manipulated to complete the emptying of the
hydrocele. This was followed by injection of 5-10 ml of 5% aqueous phenol or 2-4 ml of 1%
polidocanol. The patients in the operative treatment group were treated under local
anaesthesia with 2% lignocaine. The surgical procedure was performed on a day care basis by
eversion of sac (Jaboulay's procedure). Patients were re-assessed at 1 week, 1 month, 3
months and 6 months after treatment or whenever complications arose.
Comparability The three groups were similar in demographic characteristics..
Disparity The volume of hydrocele fluid in the surgical group (243ml) was 40-45 ml larger than the
other two. This should not happen if randomization was proper. No statistical significance is
given for this difference.

Comparison bias: Details regarding the method of random assignment are not specified.

MEASUREMENT
Measurement error
Device used Device error Observer error
Gold std.

Device suited to task

Training

Scoring

Blinding
Repetition

Protocols

Y ? N

1.Transillumination ? N ? N N N N

Measurement bias: The primary diagnosis and the detection of recurrence was made through the process of
demonstrating fluid by transillumination: a highly subjective process. It would have been preferable, and more
objective, to have used ultrasound. Presurgical dimensioning of the hydrocele would have been much more accurate.
Recurrences could have been picked up with precision.

© Dr Arjun Rajagopalan