ABSTRACT
Objectives:
To investigate the clinical value of a novel non-crosslinked
biological mesh in laparoscopic
inguinal hernia repair.
Methods:
The prospective randomized controlled study was conducted. The clinical data of 50
adult patients with unilateral
inguinal hernia who were admitted to 3 medical centers, including Ruijin
Hospital of Shanghai Jiaotong
University School of
Medicine et al, from September 2019 to March 2020 were selected. Based on random number table,
patients were divided into two groups.
Patients using the novel non-crosslinked
biological mesh in repair
surgery were divided into the experiment group and
patients using the lightweight, micro-porous, partially absorbable synthetic mesh in repair
surgery were divided into the
control group.
Observation indicators (1) grouping situations of the enrolled
patients; (2) endpoint of the study. Measurement data with
normal distribution were represented as Mean± SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M(range), and comparison between groups was conducted using the non-parameter rank sum test. Count data were described as absolute numbers and (or) persentages, and comparison between groups was conducted using the
chi-square test or Fisher exact
probability. Comparison of ordinal data was conducted using the non-parameter rank sum test. Repeated measurement data were analyzed using the repeated
ANOVA. Taking the
recurrence rate of
hernia as the basis of
efficacy evaluation, according to the
intention-to-treat
analysis, the
confidence interval method (Newcombe Wilson
method) was used to conduct non-inferiority
statistical analysis of the
recurrence rate of
hernia between the experiment group and the
control group. If the upper limit of 95%
confidence interval of the difference of
recurrence rate of
hernia between the experiment group and the
control group is less than 10%, the experiment group is considered to be non-inferior to the
control group.
Results:
(1) Grouping situations of the enrolled
patients. A total of 50
adult patients with
inguinal hernia were selected for eligibility. There were 44
males and 6
females,
aged (60±15)years. All 50
patients were randomly divided into to the experiment group and the
control group with 25 cases each. One
patient in the
control group was not followed up at postoperative month 2, and the
rest of 49
patients completed all expected follow-up. No
patient in the two groups fell off or were removed. (2) Endpoint of the study. ① The primary endpoint of study. The
recurrence rate of
hernia was 0 in the experiment group, versus 4%(1/25) in the
control group, respectively, showing no significant difference between the two groups ( P>0.05). Results of non-inferiority
statistical analysis showed that the 95%
confidence interval of the difference of
recurrence rate of
hernia between the two groups was -19.54% to 9.72%, with the upper limit as 9.72%, which was less than 10%. ② The
secondary endpoint of study. There were 2
patients in the
control group occurred
seroma at postoperative day 14, and none of the
rest of
patient in the two groups occurred
seroma during the follow-up, showing no significant difference in the occurrence of
seroma between the two groups ( P>0.05). There was 1
patient in the
control group feeling discomfort or
foreign body sensation in
groin area at postoperative month 2, and none of the
rest of
patient in the two groups
feeling discomfort or
foreign body sensation in
groin area during the follow-up, showing no significant difference in the
feeling discomfort or
foreign body sensation in
groin area between the two groups ( P>0.05). There was no
patient occurred
surgical site infection in the experiment group, and there was 1
patient in the
control group occurred postoperative
skin infection, which had no relationship with mesh. There was no
patient in both two groups occurred
fever,
anaphylaxis and patch related serious adverse reaction during the follow-up. The resting visual analogue scale score, active visual analogue scale score of
patients at postoperative 2 days and postoperative 18 months were 0.44±1.00, 1.28±1.46 and 0, 0 in the experiment group, versus 0.40±0.76, 1.28±1.14 and 0.24±1.20, 0.44±1.29 in the
control group, respectively. There was a significant difference in the
time effect of postoperative active visual analogue scale score of
patients between the two groups ( Ftime=10.19, P<0.05). The thickness of the novel non-crosslinked
biological mesh before implantation was 0.5?0.7 mm. Two months after operation, results of B-
ultrasonic examination in
groin area of 10
patients from the experiment group showed a strong echo area at the patch implant area with a thickness as 2 mm.
Conclusion:
Application of novel non-crosslinked
biological mesh in laparoscopic
inguinal hernia repair is safe and effective.