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

NCT07649434 | Not Yet Recruiting DMC

• 1 other identifier: 2026040623
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Chronic pain on the asymptomatic side at 6 months after surgery

  Pain will be measured using a numerical rating scale (NRS, 0-10 points) and documented separately for each side. At the 6 month follow up, patients will assess the most severe pain experienced in the past week for the left and right inguinal regions independently. The primary endpoint is the NRS score reported for the asymptomatic side.

  6 months after surgery

Secondary Outcomes (8)

• Pain assessment

  Postoperative day 1 and 1 month after surgery

• Short-Form Inguinal Pain Questionnaire (SF-IPQ)

  1 month and 6 months after surgery

• Quality of life (SF-36)

  Preoperatively, and at 1 month and 6 months after surgery

• Recurrence on the asymptomatic side

  6 months after surgery

• Postoperative complication rates

  Up to 6 months after surgery

Study Arms (2)

Biologic Mesh

EXPERIMENTAL

Patients in this arm receive a biological mesh (porcine urinary bladder matrix/small intestinal submucosa composite) for the contralateral asymptomatic hernia repair. The symptomatic side is repaired uniformly with a synthetic mesh (self-gripping polyester) in all patients. Both sides are repaired during the same laparoscopic TAPP procedure.

Device: Biologic Mesh

Synthetic Mesh

ACTIVE COMPARATOR

Patients in this arm receive a synthetic mesh (self-gripping polyester) for the contralateral asymptomatic hernia repair. The symptomatic side is repaired uniformly with the same synthetic mesh (self-gripping polyester) in all patients. Both sides are repaired during the same laparoscopic TAPP procedure.

Device: Synthetic Mesh

Interventions

Biologic Mesh DEVICE

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.

Biologic Mesh

Synthetic Mesh DEVICE

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

Synthetic Mesh

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years
• Unilateral symptomatic inguinal hernia with contralateral asymptomatic hernia (diagnosed either preoperatively as a clinically asymptomatic hernia or intraoperatively as an occult hernia)
• Planned for laparoscopic transabdominal preperitoneal (TAPP) repair and consent to simultaneous repair of the contralateral asymptomatic hernia
• Written informed consent obtained

You may not qualify if:

• Incarcerated or strangulated hernia requiring emergency surgery
• Inability to receive porcine-derived devices (religious or ethnic reasons)
• Participation in other interventional trials within the last 6 months
• Acute systemic infection or skin disease near the surgical site
• Chronic pain syndrome or long-term use of analgesic medications
• Pregnancy, planned pregnancy, or breastfeeding
• Any condition judged by the investigator as unsuitable for trial participation

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Xiangtan Central Hospital: collaborator
• Second Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gengwen Huang

  Xiangya Hospital of Central South University

  STUDY CHAIR

Central Study Contacts

Zhijie Chen

CONTACT

+8618850447427; 894350302@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the trial as long as the symptomatic side has not developed a recurrences.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, single-blinded, parallel-controlled trial. Eligible patients will be randomized in a 1:1 ratio to receive either biologic mesh (UBM/SIS) or synthetic mesh (self-gripping polyester) for the asymptomatic side repair. The symptomatic side will be repaired uniformly with synthetic mesh (self-gripping polyester) in all patients. The surgical procedure is laparoscopic TAPP.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 6 months after publication of the primary results.
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal, for purposes of achieving the aims in the approved proposal. Proposals should be directed to the corresponding author.

Locations

CN (1)