Page 20 - Journal of Laparoscopic Surgery

Sumanta Kumar Ghosh
incidences of seroma and chronic pain were compared
between the groups. Seroma was defined as clinical presence
of palpable fluid collection over the groin in the absence of
bruising. Operating time was defined as the time taken from
the skin incision to the last skin suture. Entry and closure
time together were separately measured in each case and this
common duration were added to either side repair time for
equitable comparison. All time measurements were approxi-
mated to the nearest integer of 5. Total number of nights spent
in the hospital after operation was defined as hospital stay.
Chronic pain was defined as discomfort /pain in the groin
area at least 3 months after surgery and debilitating enough
to interfere with daily activity requiring medical attention,
in the absence of recurrence of hernia on the side of pain.
Postoperatively all patients received one 100 mg sustained
released diclofenac tablet each day for 2 days, supplemented
by 1 gm of oral paracetamol tablet (spaced 6 hourly) on
demand basis. Paracetamol tablet was the prescribed anal-
gesic for a maximum of 7 days on discharge. Analgesic
requirement was calculated from the total amount of para-
cetamol consumed postoperatively, expressed in gram.
A sample size analysis was performed using a two-tailed Fig. 1: Trial profile
t-test with a probability of type I error (alpha) of 0.05 and
type II error (beta) of 0.2 (power 80%), and assuming a
standard deviation of 10% (expected variance of 0.01) the
required minimum sample size to prove equality of mean
for the groups is calculated to be 63 in each group. In our
study, both the groups (group 1 receiving classical TAPP
repair and group 2 receiving modified TAPP repair) had a
sample size of 65 each.
Statistical analysis was performed using computer soft-
ware (MedCalC), and outcome measures were expressed
with 95% confidence interval, p-value calculated from two-
tailed t-test or chi-squared as appropriate.
Fig. 2: Incidence of hernia type in bilateral setting as found in
ReSulTS this clinical trial

Between August 2011 and July 2012, 75 patients presented Table 1: Patient’s characteristics
with bilateral inguinal hernia were assessed for study eligi- Characteristics modified TAPP Classical TAPP p-value
bility. Figure 1 shows the profile of the trial according to (n = 65) (n = 65)
the CONSORT statement. A total of 130 inguinal hernias Age in years 50.93 47.66 0.116*
[mean (range)]
—
(28-74)
(30-78)
with bilateral occurrence in 65 patients were randomized Types of hernia
into study group (n = 65; Rx-modified TAPP) and control [number (%)]
group (n = 65; Rx-classical TAPP). Out of 65 in the control i 0 (0) 1 (0.76) —
group peritoneal closure was done with tack in 27 patients ii 8 (6.15) 10 (7.69) 0.422**
(n = 27) and by suturing in 38 patients (n = 38). The groups iiiA 46 (35.38) 44 (33.84) 0.945**
11 (8.46)
iiiB
10 (7.69)
0.461**
were comparable in age and Nyhus type of hernia as deter- Nyhus classification; *t-test statistics; **Chi-square test
mined during surgery (Table 1). Figure 2 shows incidences
of type of hernia in bilateral setting as found in this study. complication and hernia recurrence happened in study
All the TAPP repairs were successfully performed and (x = 0) and control (x = 0) group during follow-up, which
there were no conversion to open surgery. No gastrointestinal is self-explanatory regarding equality of clinical outcome
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