Hernia InguinalBiSAHNCT07649434
Effect of Biologic vs Synthetic Mesh on Chronic Pain After Laparoscopic Repair of Contralateral Asymptomatic Hernia in Patients With Unilateral Symptomatic Inguinal Hernia
A study testing Biologic Mesh and Synthetic Mesh in people with Hernia Inguinal and Biologic Mesh, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hernia Inguinal, Biologic Mesh
- What is being tested?
- Biologic Mesh and Synthetic Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Gengwen Huang, 86 15974194750, huanggengwen@csu.edu.cn
About this study
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
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.
Read more
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
- Being tested
- Biologic Mesh, Synthetic Mesh
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic MeshDevice
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.
Synthetic MeshDevice
A large-pored, lightweight, self-gripping polyester mesh. Used as active comparator for contralateral asymptomatic hernia repair during laparoscopic TAPP.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Synthetic Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Secondary outcomes (8)
Pain assessment
NRS scores (0-10) assessed on each side at postoperative day 1 (before discharge) and at the 1-month follow-up visit.
Measured: Postoperative day 1 and 1 month after surgery
Short-Form Inguinal Pain Questionnaire (SF-IPQ)
Validated questionnaire assessing pain characteristics, frequency, and impact on daily activities. Scores range from 0 to 12. Higher scores indicate more severe pain or functional limitation.
Measured: 1 month and 6 months after surgery
Quality of life (SF-36)
Short Form 36 (SF-36) assesses physical and mental health components. Scores range from 0 to 100. Higher scores indicate better quality of life.
Measured: Preoperatively, and at 1 month and 6 months after surgery
Recurrence on the asymptomatic side
Clinical recurrence defined as a reducible mass on physical examination, confirmed by ultrasound if uncertain.
Measured: 6 months after surgery
Postoperative complication rates
Incidence of seroma, hematoma, surgical site infection, and other adverse events
Measured: Up to 6 months after surgery
Patient satisfaction
The Patient Satisfaction Scale assessing patient satisfaction with the surgical outcome. Scores range from 0 to 100. Higher scores indicate greater satisfaction.
Measured: 1 month and 6 months after surgery
Operative time
Total operative time from skin incision to closure, measured in minutes.
Measured: Perioperative
Postoperative hospital stay
Cumulative length of hospital stay from the date of surgery until the 6-month follow-up, measured in days. This includes the initial postoperative stay and any re-hospitalizations related to the inguinal hernia or its surgical repair (e.g., due to recurrence, infection, seroma, hematoma, or other mesh-related complications).
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia InguinalStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangtan Central Hospital, Second Xiangya Hospital of Central South University
- Responsible party
- Sponsor
- Investigators
- Gengwen Huang, Study chair, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649434
- Sponsor's protocol ID
- 2026040623
- Acronym
- BiSAH
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in the primary publication will be shared after de-identification. The study protocol, statistical analysis plan, and informed consent form will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07649434
- Acronym / sponsor ID
- BiSAH / 2026040623
- Conditions
- Hernia Inguinal, Biologic Mesh
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Xiangtan Central Hospital, Second Xiangya Hospital of Central South University
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Biologic Mesh | Experimental | Device: Biologic MeshPatients 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. |
| Synthetic Mesh | Active comparator | Device: Synthetic MeshPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biologic MeshA 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 | Biologic Mesh |
| Synthetic MeshA large-pored, lightweight, self-gripping polyester mesh. Used as active comparator for contralateral asymptomatic hernia repair during laparoscopic TAPP. | Device | Synthetic Mesh |
Primary outcome
Chronic pain on the asymptomatic side at 6 months after surgery
Time frame: 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.
8 secondary outcomes
Pain assessment
Time frame: Postoperative day 1 and 1 month after surgery
Short-Form Inguinal Pain Questionnaire (SF-IPQ)
Time frame: 1 month and 6 months after surgery
Quality of life (SF-36)
Time frame: Preoperatively, and at 1 month and 6 months after surgery
Recurrence on the asymptomatic side
Time frame: 6 months after surgery
Postoperative complication rates
Time frame: Up to 6 months after surgery
Patient satisfaction
Time frame: 1 month and 6 months after surgery
Operative time
Time frame: Perioperative
Postoperative hospital stay
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in the primary publication will be shared after de-identification. The study protocol, statistical analysis plan, and informed consent form will also be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gengwen Huang study chair
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biologic Mesh and Synthetic Mesh in people with Hernia Inguinal and Biologic Mesh, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhijie Chen (+8618850447427, 894350302@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain on the asymptomatic side at 6 months after surgery (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.