Clinical value of a novel biological mesh in laparoscopic inguinal hernia repair: a multicenter prospective randomized controlled study / 中华消化外科杂志

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.