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

Not yet recruitingNot applicableNCT07649434
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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. Neverth…

Study details

Official title
Effect of Biologic vs Synthetic Mesh on Chronic Pain After Laparoscopic Repair of Contralateral Asymptomatic Hernia in Patients With Unilateral Symptomatic Inguinal Hernia: a Multicenter, Single-blinded, Randomized Controlled Trial
Conditions
  • Hernia Inguinal
  • Biologic Mesh
Interventions
  • Device: Biologic Mesh
  • Device: Synthetic Mesh
Sponsor
Xiangya Hospital of Central South University
Collaborators
Xiangtan Central Hospital; Second Xiangya Hospital of Central South University
Start date
2026-06
Primary completion
2027-12
Sex
All
Age range
from 18 Years to 80 Years
Results posted
No results posted in this snapshot
Countries
China
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07649434