Critical Appraisal

Jurnal Uji Klinik

Endoscopic versus open hydrocelectomy for the treatment of adult

hydroceles: a randomized controlled clinical trial

Oleh:

dr. Radinal Yusivanandra Prayitno

PPDS Departemen Obstetrik dan Ginekologi

Nim: 04052711822009

Pembimbing:

dr. Theodorus, M.Med, Sc.

RSUP. Dr. Mohammad Hoesin Palembang

Fakultas Kedokteran Universitas Sriwijaya

2018
 Critical Appraisal Jurnal Uji Klinik

Endoscopic versus open hydrocelectomy for the treatment of adult hydroceles: a

randomized controlled clinical trial

CRITICAL APPRAISAL WORKSHEET

(1) (2) (3)
Can you find this Is the way this was done a Does this problem threaten
information in the paper ? problem? the validity of the study ?

1. What is the research 1. Is it concerned with

question and/or the impact on an
hypothesis? intervention,
casuality, or
“To compare outcomes of determining the
endoscopic treatment of magnitude of a health
hydrocele with problem? No
conventional open
hydrocelectomy regarding Yes
complications and patient
satisfaction which provide “It's how the outcome of
more comfort during satisfied patients were on the
postoperative period and cosmetic results during
early return to daily endoscopic treatment and the
activities.” comfortable postoperative
period without the risk of
hematoma as in open
surgery.”

2. If not, how useful are

2. What is the study
type?
“The study was designed as a
randomized controlled
clinical trial and was
initiated after approval by the
local ethical committee.”
the results produced
2. Is the study type by this type of study?
appropriate to the
research question? Very useful as it helps
patient to undergo a less
Yes operative such as minimal
invasive procedure although
(Comparing outcomes of there is a few risk in
endoscopic treatment of applying.
hydrocele with conventional
open hydrocelectomy
regarding complications and
patient satisfaction.) 3. Do these threaten the
internal validity of the
 study?
3. What is the reference 3. Is the sampling frame
population? What are appropriate for the No
the sampling frame reference population?
and sampling Is there selection
methode? bias?

“ 54 Patients with Yes, the sampling frame is

hydrocele were randomly appropriate.
assigned for the study, by (Simple randomization)
using random sampling
number, patients were No, there is no bias
divided into two groups; selection.
endoscopic treatment
(Group1) and open surgical
treatment (Group 2). We
compared patients with
symptomatic hydrocele who
underwent a minimal
invasive operation,
'endoscopic hydrocelectomy,'
with the outcomes of open
hydrocelectomy”

“fifty four patients were

assessed ... Twenty-seven
patients clinically significant
hydrocele were enrolled into
group 1 which one patient
had bilateral hydrocele,
where as another twenty-
seven patients underwent
open hydrocelectomy. All
follow-up was done”

“The patients were divided

into two randomized
groups .... Randomization
was performed using
random sampling method.
An urologist was blind to
the type of treatment
previously performed.” 4. Does this threaten the
(Simple randomization) internal validity of the
study?

4. In an experimental 4. Has bias been No

study, how were introduced?
subjects assigned to
group? In a There’s no bias.
 longitudinal study
how many reached “fifty four patients were
final follow up? assessed ... Twenty-seven
patients clinically significant
“Patients diagnosed with hydrocele were enrolled into
hydrocele were recruited for group 1 which one patient
the study. Patients with a had bilateral hydrocele,
preoperative diagnosis of where as another twenty-
scrotal edema were still seven patients underwent
included. open hydrocelectomy. All
The patients were follow-up was done”
randomly divided into two
groups: endoscopic “The patients were divided
treatment group and an open into two randomized
hydrocelectomy group.” groups .... Randomization
was performed using
“fifty- four patients were random sampling numbers
assessed for eligibility for the method. An urologist was
study. No one is excluded. blind to the type of treatment
Therefore, still a total of 54 previously performed.”
patients were randomly (Simple randomization)
divided into two groups: 27
patients in Group 1, and 27
patients in Group 2.”

“The patients were followed

after surgery. All of the
patients were questioned at
discharge and at
postoperative day 10, as how
satisfied of the operation
procedure and another two
questions assessing cosmetic
outcome and convalescence
period...”

"All patients finished their

procedure until final follow
up although there was slight
longer before discharging as
in endoscopic treatment, two
cases with scrotal edema due
to perforation of tunica
vaginalis."

5. Is measurement error
an important source of
bias?

5. Is there measurement __
 5. What are the study error?
factors and how are
they measured? No

The treatment of hydrocele. “All of the operations were

(domain) performed under regional
Endoscopic treatment and anesthesia in dorsal
open hydrocelectomy lithotomy position as in
(Jaboulay technique). transurethral resection of the
(determinan) prostate. Prophylactic
antibiotic coverage with a
“The diagnosis was single
determined and the final shot of cefazolin (1 g,
decision for surgical intravenous) was
treatment was made by the administered on a routine
attending surgeon and basis during anesthesia.”
attending urologist, even
one of the authors were “The diagnosis was
performing the open determined and the final
surgical procedures(open decision for surgical
hydrocelectomy).” treatment was made by the
attending surgeon and
“All of the patients attending urologist, even
underwent combined one of the authors were
clinical, performing the open
radiological(ultrasonography surgical procedures(open
), and biochemical hydrocelectomy).”
evaluations for hydrocele.”
“All of the patients
underwent combined
clinical, 6.
radiological(ultrasonography a) How important
), and biochemical are omitted
evaluations for hydrocele.” outcomes?
b) Is
measurement
6. What are the outcome 6. error an
factors and how are a) Are all important
they measured? relevant source of bias?
outcome
“The primary outcome assessed? __
measure was the rate of b) Is there
patient satisfaction. measurement
Secondary outcome error?
measures were, mean age
(years) score, mean a) Yes, all relevant
operation time (minutes), outcome are assessed.
mean volume of hydrocele(
milliliters), mean follow- “The results and the
up(months), edema, comparison of outcome
hematoma, wound
dehiscence, recurrence and
positive recommendation
score, to add this all
cosmetic outcome and
evaluation of convalescence
period were recorded.”
“The patients were followed
after surgery. All of the
findings among those mean
age, mean operation time,
mean volume of hydrocele,
mean follow-up, edema,
hematoma, wound
dehiscence, recurrence and
even recommendation to
other patient, to add this all
cosmetic outcome and
evaluation of convalescence
period were recorded .”
The characteristics of the
groups were shown. (Tabel
1)
measures are presented in
Table 1. Age distribution,
volume of hydrocele and
operation time did not reveal
any statistical difference (P =
0.063, P = 0.057, P = 0.051,
respectively) between
groups.”
All of the complications
occured could be managed
well and those patients still
are discharged under 30 days
after surgery.
b) No, there is no
measurement error.
7. Is confounding an
important source of
bias?
__

7. Are potential
confounders
7. What important controlled?
potential confounders
are considered? No

There were no potential

confounders.

“Therefore, the present

study focused on cases
which only patient were
satisfied or not with the
cosmetic appearance of
their operating site after
endoscopic procedure and
also comparing a
comfortable convalescence
period with open
procedures.” 8. Were the tests
appropriate for the
8. Are statistical tests data? Are confidence
 considered? intervals given? Is the
power given?
Yes it was considered
Yes
“Statistical analysis was
performed and assessed by
SPSS (Statistical Package for 9. Is the study useful or
Social Science Inc.,Chicago, is the result
IL, USA) 12.0 package inconclusive?
problem. Chi-square
dependencies test was used Yes, the study is useful.The
for categorical data and P < result is conclusive.
0.05 was accepted as
significant” Result: There were no
9. Was the sample size significant statistical
sufficient to detect a differences between the two
9. Are the results clinically/socially groups in terms of mean age,
clinically/socially significant result? mean operation time, mean
important? volume of hydrocele.
Yes
Yes
“... a total of 54 patients were
“In the treatment hydrocele randomly divided into two
patient, endoscopic groups: 27 patients in
hydrocelectomy is among the Group 1, and 27 patients in
alternative treatment of Group 2.”
hydrocelectomy, where it
provides a very comfortable
postoperative period without
risk of hematoma and even
cosmetic results were 10. Do you accept the
satisfied. However there is results of this study?
need for literature
accumulation of the topic Yes, I do.
regarding comparing with
open surgery.”

10. Do the results apply

to the population in
10. What conclusions did which you would be
the authors reach interested?
about the research
question? Did they Yes.
generate new
hypotheses? Do you
agree with the
conclusions?
“ Endoscopic
hydrocelectomy is among the
treatment alternatives of
hydrocelectomy also a viable
option in treating hydrocele.
It provides a very
comfortable postoperative
period without hematoma
risk and better in cosmetic
outcome when compared
with conventional treatment
although there is a need of
more accumulation literature
on this topic."

They don't generate new

hypothesis

Yes, I agree with the

conclusions.