Objective To investigate the long‑term effects of porcine small intestinal submucosa (SIS) biologic mesh in open Lichtenstein tension‑free hernia repair.

Methods The prospective randomized controlled study was conducted. The clinical data of 76 patients with unilateral inguinal hernia who underwent open Lichtenstein tension‑free hernia repair in 2 medical centers (52 cases in Tianjin People′s Hospital and 24 cases in China‑Japan Friendship Hospital) from August 2013 to March 2014 were selected. Based on random number method, patients were allocated into two groups. Patients undergoing Lichtenstein tension‑free hernia repair using Biodesign Surgisis mesh were allocated into control group, and patients undergoing Lichtenstein tension‑free hernia repair using SIS biologic mesh were allocated into experiment group. Observa-tion indicators: (1) grouping situations of the enrolled patients; (2) postoperative long‑term effects. Follow‑up was conducted using telephone interview, text message or mail to detect hernia recurrence or death due to other reasons as the end‑point event of patients up to December 2019. 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 by M (range), and comparison between groups was conducted using the Mann‑Whitney U test. Count data were described as absolute numbers, and comparison between groups was conducted using the chi‑square test or Fisher exact probability.

Results (1) Grouping situations of the enrolled patients: a total of 76 patients were selected for eligibility. There were 38 cases in the control group and the experiment group, respectively. The number of males and females, age, body mass index, cases with intraspinal anesthesia or local anesthesia (anesthesia method), cases with inguinal hernia on the left side or on the right side, cases classified as type Ⅰ, Ⅱ, Ⅲ, Ⅳ or Ⅴ of Gilbert classification, operation time of the control group were 35, 3, (56±15)years, (23.0±2.0)kg/m², 22, 16, 16, 22, 9, 16, 0, 11, 2 and (49±15)minutes, respectively. The above indicators of the experiment group were 34, 4, (54±13)years, (22.9±2.2)kg/m², 17, 21, 14, 24, 9, 21, 1, 7, 0, and (53±21)minutes, respectively. There was no significant difference in the above indicators between the two groups (χ²=0.157, t=0.532, 0.367, χ²=1.317, 0.220, Z=-0.315, t=-0.765, P>0.05). (2) Post-operative long‑term effects: 35 patients of the control group were followed up for (68.8±2.7)months, 4 cases of which died due to other reasons, 1 case had hernia recurrence, 1 case had chronic pain and no foreign body sensation and postoperative infection occurred. Thirty‑one patients of the experiment group were followed up for (68.8±2.7)months, with no death or above complications. There was no significant difference in hernia recurrence or chronic pain between the two groups (P>0.05).

Conclusion The long‑term effects of biological mesh in open Lichtenstein tension‑free hernia repair is satisfactory and there is no difference in the long‑term effects between the domestic SIS biological mesh and Biodesign Surgisis mesh.