Hernia, Inguinal

7

Review clinical trials related to Hernia, Inguinal. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 90
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Xiangya Hospital of Central South UniversityUpdated: Jun 16, 2026Locations: 1
Eligibility criteria

Age 18 to 80 years [+3]

Incarcerated or strangulated hernia requiring emergency surgery [+6]

Status: Recruiting

Comparison of Postoperative Analgesic Effects of Quadro-iliac Plane Block and Transversus Abdominis Plane Blocks in Inguinal Hernia Surgery

Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide. Despite being classified as a minor surgical intervention, moderate to severe postoperative pain is reported in approximately 60% of patients. In a subset of these patients, acute postoperative pain may persist and evolve into chronic post-surgical inguinal pain, significantly affecting quality of life. In recent years, beyond the use of systemic intravenous analgesics, ultrasound-guided fascial plane blocks have been increasingly incorporated into multimodal analgesia protocols with the aim of reducing postoperative opioid consumption and improving pain control. However, the current literature does not provide definitive evidence regarding the superiority of one block technique over another in this surgical population. The primary objective of the present study is to compare the analgesic efficacy of the Quadro-iliac Plane Block (QIPB) and the transversus abdominis plane block (TAPB) in patients undergoing inguinal hernia repair.

Participants needed: 60
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Ankara Etlik City HospitalUpdated: Jun 3, 2026Locations: 1
Eligibility criteria

Patients aged between 18 and 65 years [+3]

Patients younger than 18 years or older than 65 years. [+5]

Status: Recruiting

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.

Participants needed: 160
Trial details
Age: 21+Biological sex: AllType: InterventionalSponsor: Tela Bio IncUpdated: May 5, 2026Locations: 10
Eligibility criteria

Subject suffers from a ventral or inguinal hernia that requires surgical repair... [+7]

Subject has a BMI of > 40 [+9]

Status: Recruiting

Pneumoperitoneum Duration and Bicarbonate Changes in Laparoscopic Hernia Surgery

The goal of this observational study is to learn how the length of pneumoperitoneum during laparoscopic inguinal hernia surgery may affect changes in blood bicarbonate levels. Pneumoperitoneum is the use of carbon dioxide gas to create space inside the abdomen during laparoscopic surgery. The main question this study aims to answer is whether a longer pneumoperitoneum time is associated with changes in blood bicarbonate levels after surgery. Participants are adults undergoing laparoscopic inguinal hernia repair as part of their routine medical care. Researchers will measure blood gas values, including bicarbonate levels, before surgery and again two hours after surgery. The change in bicarbonate levels will be compared with the duration of pneumoperitoneum during the operation. The results of this study may help improve the understanding of metabolic changes that occur during laparoscopic surgery.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Haseki Training and Research HospitalUpdated: Mar 16, 2026Locations: 1
Eligibility criteria

Age ≥18 years [+2]

Pregnancy [+4]

Status: Recruiting

A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot

The goal of this observational study is to understand the utility of force feedback instruments in surgeries that are done using the da Vinci 5 robot.

Participants needed: 200
Trial details
Age: 22+Biological sex: AllType: ObservationalSponsor: Intuitive SurgicalUpdated: Feb 25, 2026Locations: 5
Eligibility criteria

Age 22 years or older [+4]

Subject receiving an emergent procedure [+12]

Status: Not yet recruiting

Safety and Efficacy of the 3DMax™ MID Anatomical Mesh (BD, USA) in Laparoscopic-endoscopic Inguinal Hernia Repair - Multicenter, Prospective Observational Study

This is a multicenter, prospective, observational cohort study evaluating the safety and efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in laparoendoscopic inguinal hernia repair. Adult patients undergoing elective transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) repair will be enrolled and followed according to routine clinical practice. The primary objective is to assess the inguinal hernia recurrence rate within 12 months after surgery. Secondary objectives include evaluation of postoperative pain, groin discomfort and foreign body sensation, as well as early and late postoperative complications. All participating patients will receive the 3DMax MID Anatomical Mesh as part of standard care. No additional experimental procedures are planned. Clinical data will be collected at baseline and during predefined follow-up contacts (early postoperative period, 1 month, 3 months and 12 months) using standardized forms and patient interviews.

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Swissmed HospitalUpdated: Dec 17, 2025
Eligibility criteria

Age 18 years or older [+5]

Age below 18 years [+5]

Status: Recruiting

Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair

This study is evaluating the management of chronic post-operative inguinal hernia pain and the impact of hernia mesh removal after previous minimally invasive inguinal hernia repairs. The study aims are to evaluate the change in chronic (\>6 months), nociceptive, postoperative inguinal pain after mesh removal compared to no mesh removal in patients who have previously undergone minimally invasive inguinal hernia repair with pre-peritoneal mesh.

Participants needed: 70
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: David KrpataUpdated: Oct 6, 2025Locations: 1
Eligibility criteria

> 18 years of age [+7]

No characteristics of nociceptive groin pain [+6]