Effect of Biologic vs Synthetic Mesh on Chronic Pain After Laparoscopic Repair of Contralateral Asymptomatic Hernia in Patients With Unilateral Symptomatic Inguinal Hernia

Summary

Inguinal hernia is one of the most common conditions in general surgery. In clinical practice, surgeons frequently face a dilemma: during the evaluation of a patient with unilateral symptomatic inguinal hernia, a contralateral asymptomatic defect is discovered-either preoperatively on physical examination or intraoperatively during laparoscopy. The question then becomes: how should this incidental finding be managed? Epidemiological data show that the incidence of such contralateral asymptomatic hernias can be as high as 20%. The management strategy for these hernias has changed considerably over time. Although traditional "watchful waiting" was once widely adopted, long-term follow-up studies have demonstrated that approximately 70% of asymptomatic patients eventually require surgery due to symptom progression, and increasing age is associated with higher surgical risks. Consequently, with the widespread adoption of laparoscopic techniques, simultaneous repair of asymptomatic hernias during the initial surgery has become a common clinical choice.

However, this decision raises a critical question: how can the surgeon balance the need to repair the existing anatomical defect against the risk of introducing new long-term complications from the intervention? This makes the choice of repair material particularly important. Currently, synthetic polypropylene meshes, with their proven effectiveness in reducing recurrence rates, are considered the gold standard for inguinal hernia repair. However, as permanent implants, they may be associated with long-term complications-chronic postoperative pain and foreign body sensation, which affect patients' long-term quality of life.

Biologic meshes offer a different option. Derived from decellularized extracellular matrix, they are designed as temporary scaffolds that guide autologous tissue regeneration and ultimately degrade. Theoretically, this avoids a permanent foreign body reaction and may reduce long-term discomfort. Nevertheless, the clinical value of biologic meshes in inguinal hernia repair remains controversial. Some studies suggest that biologic meshes reduce chronic pain and improve quality of life; others show no difference in pain or recurrence rates compared with synthetic meshes. Meta-analyses have not demonstrated clear superiority of biologic over synthetic meshes in overall complications, recurrence, or chronic pain, and the heterogeneity among existing studies is high.

The BIOLAP randomized clinical trial, published in JAMA Surgery in 2025, provided high-level evidence for symptomatic bilateral hernias. It showed that in laparoscopic inguinal hernia repair, biologic mesh did not significantly reduce postoperative pain. Moreover, it was associated with a significantly higher 2-year recurrence rate (11.2% vs. 2.5%) and a higher seroma rate (33.4% vs. 21.6%). However, a key question remains: can these conclusions be directly extrapolated to the setting of contralateral asymptomatic hernia repair, where the therapeutic goal is to maximize long term comfort rather than to relieve existing symptoms? The investigators previously conducted an exploratory single-center randomized controlled study (n=52, BiSOH) that addressed this question preliminarily. In that trial, the biologic mesh group had significantly lower inguinal pain scores at both 1 month and 6 months, with pain decreasing over time in both groups. Quality of life measured by SF-36 was significantly better in the biologic mesh group at both follow-up time points, and the EQ-5D score was higher at 6 months. These findings suggest that biologic mesh may offer advantages in chronic pain control and quality of life for occult hernia repair, contrasting with the BIOLAP conclusions. However, the single center design and methodological limitations prevented confirmation of the primary endpoint difference, highlighting the need for a multicenter, high-quality clinical trial.

Currently, international guidelines lack high level evidence on the optimal mesh type for simultaneous repair of contralateral asymptomatic hernias. Therefore, this multicenter, randomized, single-blinded, parallel-controlled trial was designed to compare biologic versus synthetic meshes in this specific scenario. The hypothesis is that the use of a biologic mesh (porcine UBM/SIS composite) reduces chronic pain on the asymptomatic side at 6 months without increasing recurrence, compared with a synthetic mesh (self-gripping polyester).

The biologic mesh is a porcine urinary bladder matrix and small intestinal submucosa composite (UBM/SIS) manufactured by ZR Medtech (Suzhou, China). It is a non-cross-linked, acellular, collagenous matrix produced through patented decellularization and antigen removal processes. It has been used for various soft tissue defect repairs.

Conditions

• Hernia Inguinal
• Biologic Mesh

Interventions

DEVICE

Biologic Mesh

A non-cross-linked, acellular, collagenous matrix derived from porcine urinary bladder matrix and small intestinal submucosa (UBM/SIS). Unlike permanent synthetic meshes, this biological mesh is designed to gradually degrade and be replaced by autologous tissue, potentially reducing chronic pain and foreign body sensation. Used for contralateral asymptomatic hernia repair during laparoscopic TAPP.

DEVICE

Synthetic Mesh

A large-pored, lightweight, self-gripping polyester mesh. Used as active comparator for contralateral asymptomatic hernia repair during laparoscopic TAPP.

Sponsors & Collaborators

• Xiangtan Central Hospital

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Xiangya Hospital of Central South University

  lead OTHER

Principal Investigators

• Gengwen Huang · Xiangya Hospital of Central South University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2027-12-31

Completion

2028-01-31

Countries

• China

Study Locations