A Phase 4 interventional study of OnabotulinumtoxinA Injection and Saline (placebo) Injection in Hernia Abdominal Wall, Botox Injection and Hernia Incisional Ventral, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by The Cleveland Clinic · Phase 4, Interventional, and Treatment
Among 94 studies in Hernia, Ventral with a site in United States — 14 open to participants now, 25 under way, none of them phase 3. Hernia, Ventral · United States.
Among the 94 studies in Hernia, Ventral with a site in United States, this one is the 17th largest by planned enrollment of the 70 interventional ones, is one of 6 that started in 2025, is one of 8 in phase 4, reaches primary completion later than 20 of the 24 other live ones, and was the 87th registered.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 188 is above the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →14 of the 94 studies in Hernia, Ventral with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 26 Hernia, Ventral studies recruiting now, 19 (73%) set no upper age limit and 4 (15%) stop at 75 or younger; 1 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →94 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 6 started in 2025.
Median enrollment 100 across the 70 interventional studies, 63 across the 24 observational. Of the 58 that completed or were terminated, 31 (53%) have results posted.
32 of 94 have an industry lead sponsor. The 10 most frequent:
The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
The Cleveland Clinic has 9 studies filed under Hernia, Ventral — fewer than ten, so there is no comparison to draw.
10 of the studies in Hernia, Ventral with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04718168W.L.Gore & AssociatesGORE® ENFORM Biomaterial Product Study | 2026-12 |
| NCT07639281Tori DotsonOpioid Education Ventral Hernia Repair | 2026-12 |
| NCT07874724University of South FloridaCryoneurolysis for Abdominal Wall Relaxation Prior to Ventral Hernia Repair | 2027-03-01 |
| NCT04779918Tela Bio IncVentral or Inguinal Hernia, Robotically Repaired With OviTex Mesh | 2027-03-30 |
| NCT06874413Prisma Health-UpstateTargeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair | 2027-04-30 |
Among the 94 studies in Hernia, Ventral with a site in United States, from their registry updates:
This study is for adults who need open surgery to repair a very large abdominal (ventral) hernia. This study tests whether a one-time, image-guided injection of a medicine commonly known as "BOTOX®" (onabotulinumtoxinA) into the side abdominal muscles 3-7 weeks before surgery helps surgeons close the abdominal wall fully at the end of the operation. Closing the muscle and tissue layers ("primary fascial closure") is linked to fewer problems after surgery and better quality of life.
Participants will be randomly assigned (like a coin flip) to receive either the BOTOX® medicine or a saltwater (placebo) injection. Neither patients nor the care team will know which one was given. All participants will still have their planned hernia repair in the standard way that we repair patients who are not part of the study. The study will track whether the abdomen can be closed without leaving a gap, and investigators will also look at recovery, complications, time in the ICU or on a ventilator, length of stay, pain, and quality-of-life scores. Most information will be collected during participants' hospital stay, but the investigators will continue to see how participants are doing up to 2 years after surgery. Short phone check-ins will occur before surgery, and after surgery follow-up happens around 30 days, 90 days, 1 year, and 2 years.
Possible risks from the injection include temporary muscle weakness, trouble swallowing or breathing, pain or infection at the injection site, and (if CT is used for guidance) a small amount of radiation exposure. Surgery itself carries the usual risks (pain, bleeding, wound problems). Benefits are not guaranteed, but the injection may make closure easier and recovery smoother. About 188 people will take part at Cleveland Clinic.
Background and Rationale:
Massive ventral hernias (pre-op axial width ≥15 cm and/or Tanaka volume ratio >25%) seldom achieve primary fascial closure (PFC) and are associated with higher respiratory morbidity, intensive care unit (ICU) utilization, post-operative pain, hospital length of stay (LOS), cost, and recurrence. Spasticity/fibrosis of the external oblique-internal oblique-transversus abdominis (EO/IO/TA) complex likely limits lateral abdominal wall compliance and impedes midline medialization. Pre-operative, image-guided onabotulinumtoxinA (BOTOX®) has been proposed to elongate the lateral wall, enlarge the functional abdominal domain, reduce closure pressures, and thereby increase the primary fascial closure (PFC) rate. Prior institutional data show \~77% PFC in this population without pre-op toxin, whereas retrospective series suggest \~95% with toxin utilization, motivating a definitive randomized trial.
Design:
Single-center, randomized, double-blind, placebo-controlled superiority trial. Randomization uses pre-generated block allocation (statistician-generated). Analyses will be intention-to-treat (ITT), with a parallel per-protocol (PP) analyses limited to participants who receive the assigned injection and undergo AWR within 21-48 days post-injection. A single interim analysis is planned at 50% completion of primary endpoint. Intention-to-treat (ITT) is primary method of analysis; however, a per-protocol (PP) analysis will also be conducted as this supports causal inference among adherent participants. An independent DMC will review interim results and advise on continuation/early stopping.
Interventions:
Fully described in 'Arms and Interventions' section. Participants will either receive image-guided injections of BOTOX® at six sites on the lateral abdominal wall (three sites per side) with a total of 300 units give (2 u / cc concentration; 25 cc at each site); or, participants will receive the same volume of a 0.9% saline solution (25 cc at each site).
End Points and Outcomes:
Fully described in the 'Outcomes Measures' section. Primary endpoint is primary fascial closure (PFC), the successful closure of hernia defect at the conclusion of the case. Additional secondary outcomes regarding clinical course and patient-reported outcomes will be captured at 30 days, 90 days, 1 year, and 2 years.
Exploratory outcomes include cost and healthcare utilization information, as well as comparison of physiological parameters between treatment groups.
Data Stewardship:
Primary data capture occurs in the ACHQC registry, supplemented by an institutional REDCap database for variables not routinely captured (e.g., physiologic measures) in the registry.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 188 is above the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Compared within Hernia, Ventral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hernia, Abdominal. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
These patients will receive image-guided botulinumtoxin injections as described 21-48 days prior to open ventral hernia repair.
Procedure: OnabotulinumtoxinA Injection · Drug: OnabotulinumtoxinA · Procedure: Open Ventral Hernia Repair
These patients will receive image-guided saline (placebo) injections as described 21-48 days prior to open ventral hernia repair.
Procedure: Saline (placebo) Injection · Drug: 0.9 % Normal Saline · Procedure: Open Ventral Hernia Repair
A total of 300 units of onabotulinumtoxinA will be reconstituted 150 cc of injectable 0.9% NaCl (for a final concentration of 2 units / cc). Each side of the abdominal wall will receive a total 75 cc distributed across three injection sites (six injection sites total per patient). At each injection site, the muscle bodies of the transversus abdominis, internal oblique, and external oblique will receive an equivalent volume of product under ultrasonic or radiographic visualization.
Also known as: BOTOX® Injection
150 cc of injectable 0.9% NaCl will be prepared. Each side of the abdominal wall will receive a total 75 cc distributed across three injection sites. At each injection site, the muscle bodies of the transversus abdominis, internal oblique, and external oblique will receive an equivalent volume of product under ultrasonic or radiographic visualization.
300 units of onabotulinumtoxinA will be prepared and administered as described in: "Procedure/Surgery: OnabotulinumtoxinA Injections"
Also known as: BOTOX®
150cc of normal saline will be prepared and administered as described in: "Procedure/Surgery: Saline (placebo) Injection".
Also known as: Saline, Salt Water, Placebo, Normal Saline, NaCl
Open abdominal wall reconstruction will be conducted in our standard fashion for the repair of very large hernias. The surgery is the same for patients who are not in the study. Surgeons will be blinded to the study arm of participant patients.
Also known as: Abdominal Wall Reconstruction, Posterior Component Separation
Primary Fascial Closure (PFC) at conclusion of Hernia Surgery (Yes / No, determined by surgeon)
Primary fascial closure (PFC) is the successful closure of the hernia. It will be defined in a binary, categorical manner as: "Yes" (fascial closed) or "No" (fascia not closed and bridging mesh required). To be considered "Yes" for PFC, the midline anterior fascia must be completely re-approximated via absorbable running or figure-of-eight sutures. If any segment of the anterior fascia cannot be approximated and closed, the patient will require anterior bridging and this would be considered a failure of PFC. Surgeons will decide if the fascia can be closed or if it cannot be closed by their expertise and discretion. No prespecified criteria have been established which dictate operative decision-making. The study team will record an outcome of "Yes" for PFC if the fascia is successfully closed by the surgeon via an eligible technique as previously described.
Time frame: This will be measured (recorded) on the day of the hernia repair surgery, which will be 21 to 48 days after receiving your BOTOX injection.
30-Day Surgical Site Occurrence (SSO) - Proportion of Participants (%)
SSOs will be abstracted from the clinical record in a prospective fashion. They are defined as wound-related problems at or near the incision within 30 days of surgery (e.g., infection, fluid or blood collections, wound separation, or skin edge death). These will be measured on an individual level basis, and will be captured via patient interview and chart review within the specified timeframe. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day Surgical Site Infection (SSI) - Proportion of Participants (%)
Any incisional or organ/space infection within 30 days, identified by treating teams. These will be measured on an individual level basis, and will be captured via patient interview, clinician-report, and/or chart review within the specified timeframe. Defined via any antibiotic and/or antimicrobial treatment of an infection at the surgical site. Positive culture or proof of pathogen not needed. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day SSOPI (Surgical Site Occurrence Requiring Procedural Intervention) - Proportion of Participants (%)
These are SSO events (as described in 30-Day SSO outcome) that required a bedside/clinic or OR procedure (e.g., aspiration, drainage, debridement) within 30 days. Cumulative SSOPIs will be calculated for each group. Additionally, aggregate calculation for a study group: numerator = participants with ≥1 SSOPI; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day Readmission - Proportion of Participants (%)
Any inpatient hospital readmission within 30 days of index surgery. "How measured": EHR review/REDCap; unit = participants (%).
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day Reoperation - Proportion of Participants (%)
Any return to the operating room related to the index surgery within 30 days. "How measured": EHR/REDCap; unit = participants (%).
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day Hospital Length of Stay - Days
Days from operation to hospital discharge. "How measured": EHR discharge date minus surgery date; unit = days.
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day ICU Admission - Proportion of Participants (%)
Any ICU care during the index stay or within 30 days (planned or unplanned). "How measured": EHR/REDCap; unit = participants (%).
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
Duration of Mechanical Ventilation (Index Hospitalization) - Hours
Total ventilator time during and after surgery until final extubation during the index stay. Will be sub-divided as during surgery and after surgery. "How measured": anesthesia/intensive care record; unit = hours (may also be displayed as days:hours)
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day Myocardial Infarction (MI) - Proportion of Participants (%)
MI within 30 days per treating clinician diagnosis. "How measured": medical record review, patient interview, and/or clinical diagnosis. Unit = participants (%).
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day Pneumonia - Proportion of Participants (%)
Clinically diagnosed pneumonia within 30 days. "How measured": patient interview, medical record review, or clinical diagnosis. Unit = participants (%).
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day Renal Failure/Acute Kidney Injury (AKI) - Proportion of Participants (%)
Acute kidney injury/failure within 30 days. "How measured": clinician diagnosis, medical record review, and/or KDIGO Guidelines. Unit = participants (%).
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day Post-operative Ileus - Proportion of Participants (%)
Ileus requiring clinical management within 30 days. Defined as placement of an nasogastric tube or clinical diagnosis by surgeon based on intolerance of oral intake or delayed return of bowel function. "How measured": medical record review or clinician diagnosis. Unit = participants (%).
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Short Form 3a - T-Score (Raw Response score range: 0-10, Higher = Worse Pain)
Three-item pain intensity questionnaire. "How measured": PROMIS-3a administered at follow-up; raw sum (3-15) converted to T-score (mean 50, SD 10); higher scores = more pain (worse). Unit = T-score.
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day Hernia-Related Quality-of-Life Survey (HerQLes) - Score (0-100; Higher = Better QoL)
12-item hernia-specific QoL instrument. "How measured": HerQLes administered at follow-up; score transformed 0-100, higher = better function/less disability. Unit = total score (0-100).
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
30-Day Complication Severity (Clavien-Dindo) - Distribution of Highest Grade (I-V)
Highest complication grade based on the Clavien-Dindo classification system per participant within 30 days. "How measured": graded in REDCap from clinical documentation; unit = participants in each grade (%). Minimum = I, maximum = V; higher grades = worse.
Time frame: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.
90-Day SSO - Proportion of Participants (%)
SSOs will be abstracted from the clinical record in a prospective fashion. They are defined as wound-related problems at or near the incision within 90 days of surgery (e.g., infection, fluid or blood collections, wound separation, or skin edge death). These will be measured on an individual level basis, and will be captured via patient interview and chart review within the specified timeframe. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.
90-Day SSI - Proportion of Participants (%)
Any incisional or organ/space infection within 90 days, identified by treating teams. These will be measured on an individual level basis, and will be captured via patient interview, clinician-report, and/or chart review within the specified timeframe. Defined via any antibiotic and/or antimicrobial treatment of an infection at the surgical site. Positive culture or proof of pathogen not needed. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.
90-Day SSOPI - Proportion of Participants (%)
These are SSO events (as described in 30-Day SSO outcome) that required a bedside/clinic or OR procedure (e.g., aspiration, drainage, debridement) within 90 days. Cumulative SSOPIs will be calculated for each group. Additionally, aggregate calculation for a study group: numerator = participants with ≥1 SSOPI; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.
90-Day Complication Severity (Clavien-Dindo) - Distribution of Highest Grade (I-V)
Highest complication grade based on the Clavien-Dindo classification system per participant within 90 days. "How measured": graded in REDCap from clinical documentation; unit = participants in each grade (%). Minimum = I, maximum = V; higher grades = worse.
Time frame: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.
90-Day Comprehensive Complication Index (CCI) Score at 90 Days - Score
Comprehensive Complication Index® score, which is a weighted score based on the number of complications in each Clavien-Dindo group within 90 postoperative days. "How measured": the individuals CCI score at 90-days, as calculated via https://www.cci-calculator.com/.
Time frame: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.
90-Day Readmission - Proportion of Participants (%)
Any inpatient hospital readmission within 30 days of index surgery. "How measured": EHR review/REDCap; unit = participants (%).
Time frame: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.
90-Day Reoperation - Proportion of Participants (%)
Any return to the operating room related to the index surgery within 90 days. "How measured": patient interview, medical record review, surgeon report; unit = participants (%).
Time frame: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.
90-Day Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Short Form 3a - T-Score (Raw Response score range: 0-10, Higher = Worse Pain)
Three-item pain intensity questionnaire. "How measured": PROMIS-3a administered at follow-up; raw sum (3-15) converted to T-score (mean 50, SD 10); higher scores = more pain (worse). Unit = T-score.
Time frame: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.
90-Day Hernia-Related Quality-of-Life Survey (HerQLes) - Score (0-100; Higher = Better QoL)
12-item hernia-specific QoL instrument. "How measured": HerQLes administered at follow-up; score transformed 0-100, higher = better function/less disability. Unit = total score (0-100).
Time frame: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.
1-Year Surgical Site Occurrence (SSO) - Proportion of Participants (%)
SSOs will be abstracted from the clinical record in a prospective fashion. They are defined as wound-related problems at or near the incision within 1 year of surgery (e.g., infection, fluid or blood collections, wound separation, or skin edge death). These will be measured on an individual level basis, and will be captured via patient interview and chart review within the specified timeframe. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 1 year after hernia repair surgery
1-Year Surgical Site Infection (SSI) - Proportion of Participants (%)
Any incisional or organ/space infection within 1 year, identified by treating teams. These will be measured on an individual level basis, and will be captured via patient interview, clinician-report, and/or chart review within the specified timeframe. Defined via any antibiotic and/or antimicrobial treatment of an infection at the surgical site. Positive culture or proof of pathogen not needed. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 1 year after hernia repair surgery
1-Year SSOPI - Proportion of Participants (%)
These are SSO events (as described in 30-Day SSO outcome) that required a bedside/clinic or OR procedure (e.g., aspiration, drainage, debridement) within 1 year. Cumulative SSOPIs will be calculated for each group. Additionally, aggregate calculation for a study group: numerator = participants with ≥1 SSOPI; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 1 year after hernia repair surgery
1-Year Reoperation
Any return to the operating room related to the index surgery within 1 year. "How measured": patient interview, medical record review, surgeon report; unit = participants (%).
Time frame: Approximately 1 year after hernia repair surgery
1-Year Reoperation for Hernia Recurrence
Any return to the operating room related repair of a hernia within 7 cm of the hernia repaired in the original surgery within 1 year. "How measured": patient interview, medical record review, surgeon report; unit = participants (%).
Time frame: Approximately 1 year after hernia repair surgery
1-Year Hernia Recurrence (Clinical)
A recurrence after hernia repair is defined as a new hernia detected within 7cm of the original repair. The hernia must be determined via imaging (ultrasound, computed tomography scan, or magnetic resonance imaging scan) or the documented physical exam of a licensed practitioner. Determined as within 1 year of the hernia repair surgery.
Time frame: Approximately 1 year after hernia repair surgery
1-Year Hernia Recurrence (Patient-Reported)
Patient self-reported concern for recurrence based on response to the the question, "Do you feel or see a bulge?" on the Ventral Hernia Recurrence Inventory (VHRI) questionnaire. Asked at 1 year.
Time frame: Approximately 1 year after hernia repair surgery
1-Year Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Short Form 3a - T-Score (Raw Response score range: 0-10, Higher = Worse Pain)
Three-item pain intensity questionnaire. "How measured": PROMIS-3a administered at follow-up; raw sum (3-15) converted to T-score (mean 50, SD 10); higher scores = more pain (worse). Unit = T-score.
Time frame: Approximately 1 year after hernia repair surgery
1-Year Hernia-Related Quality-of-Life Survey (HerQLes) - Score (0-100; Higher = Better QoL)
12-item hernia-specific QoL instrument. "How measured": HerQLes administered at follow-up; score transformed 0-100, higher = better function/less disability. Unit = total score (0-100).
Time frame: Approximately 1 year after hernia repair surgery
2-Year Surgical Site Occurrence (SSO) - Proportion of Participants (%)
SSOs will be abstracted from the clinical record in a prospective fashion. They are defined as wound-related problems at or near the incision within 2 years of surgery (e.g., infection, fluid or blood collections, wound separation, or skin edge death). These will be measured on an individual level basis, and will be captured via patient interview and chart review within the specified timeframe. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 2 years after hernia repair surgery
2-Year Surgical Site Infection (SSI) - Proportion of Participants (%)
Any incisional or organ/space infection within 2 years, identified by treating teams. These will be measured on an individual level basis, and will be captured via patient interview, clinician-report, and/or chart review within the specified timeframe. Defined via any antibiotic and/or antimicrobial treatment of an infection at the surgical site. Positive culture or proof of pathogen not needed. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 2 years after hernia repair surgery
2-Year SSOPI - Proportion of Participants (%)
These are SSO events (as described in 30-Day SSO outcome) that required a bedside/clinic or OR procedure (e.g., aspiration, drainage, debridement) within 2 years. Cumulative SSOPIs will be calculated for each group. Additionally, aggregate calculation for a study group: numerator = participants with ≥1 SSOPI; denominator = all randomized participants who underwent surgery; unit = participants (%).
Time frame: Approximately 2 years after hernia repair surgery
2-Year Reoperation
Any return to the operating room related to the index surgery within 2 years. "How measured": patient interview, medical record review, surgeon report; unit = participants (%).
Time frame: Approximately 2 years after hernia repair surgery
2-Year Reoperation for Hernia Recurrence
Any return to the operating room related repair of a hernia within 7 cm of the hernia repaired in the original surgery within 2 years. "How measured": patient interview, medical record review, surgeon report; unit = participants (%).
Time frame: Approximately 2 years after hernia repair surgery
2-Year Hernia Recurrence (Clinical)
A recurrence after hernia repair is defined as a new hernia detected within 7cm of the original repair. The hernia must be determined via imaging (ultrasound, computed tomography scan, or magnetic resonance imaging scan) or the documented physical exam of a licensed practitioner. Determined as within 2 years of the hernia repair surgery.
Time frame: Approximately 2 years after hernia repair surgery
2-Year Hernia Recurrence (Patient-Reported)
Patient self-reported concern for recurrence based on response to the the question, "Do you feel or see a bulge?" on the Ventral Hernia Recurrence Inventory (VHRI) questionnaire. Asked at 2 years.
Time frame: Approximately 2 years after hernia repair surgery
2-Year Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Short Form 3a - T-Score (Raw Response score range: 0-10, Higher = Worse Pain)
Three-item pain intensity questionnaire. "How measured": PROMIS-3a administered at follow-up; raw sum (3-15) converted to T-score (mean 50, SD 10); higher scores = more pain (worse). Unit = T-score.
Time frame: Approximately 2 year after hernia repair surgery
2-Year Hernia-Related Quality-of-Life Survey (HerQLes) - Score (0-100; Higher = Better QoL)
12-item hernia-specific QoL instrument. "How measured": HerQLes administered at follow-up; score transformed 0-100, higher = better function/less disability. Unit = total score (0-100).
Time frame: Approximately 2 year after hernia repair surgery
Fascial Tension (Pre-Release and Post-Component Separation) - Force Units (lbs)
Force required to bring each fascial edge to midline, measured twice: (1) after initial dissection/before retro-rectus release and (2) after each step during posterior component separation. "How measured": sterile Kocher clamps attached to fascia will be connected to a sterilizable tensiometers which is pulled until midline is reached by medial fascial edge; force recorded. Unit = pounds of force (lbs); higher values = greater tension.
Time frame: During hernia repair surgery
Plateau Airway Pressure - cmH₂O
Ventilator plateau pressure measured (a) after intubation before incision, (b) just before skin closure (after repair), and (c) POD1 if still intubated. "How measured": volume-controlled ventilation; inspiratory pause 0.5-3 s; stabilized pressure recorded as Pplat; also record PIP, tidal volume, ventilator mode, PEEP, FiO₂. Unit = cmH₂O.
Time frame: During hernia repair surgery and one day after surgery (if still requiring mechanical ventilation post-operatively)
Change in Plateau Pressure With Closure - cmH₂O
Difference between pre-closure and post-closure plateau pressures; negative change indicates improved mechanics. "How measured": subtraction of time-point values. Unit = cmH₂O.
Time frame: During hernia repair surgery
Bladder Pressure (Intra-abdominal Pressure Proxy) - mmHg
Measured three times for all patients: (1) after anesthesia before incision and (2) immediately pre-extubation; also (3) on POD1 prior to Foley removal. "How measured": per WSACS consensus - instill ≤25 mL sterile saline via stopcock into a clamped Foley; patient supine with bed flat; transduce at mid-axillary line at end-expiration. Unit = mmHg.
Time frame: During hernia repair surgery and one day after surgery (if foley remains in place)
Abdominal Perfusion Pressure (APP) - mmHg
Calculated as mean arterial pressure (MAP) - intra-abdominal pressure (from bladder pressure). "How measured": MAP (non-invasive or invasive, properly zeroed will be collected during regular care) and bladder pressure (as described above); APP computed. Unit = mmHg
Time frame: During hernia repair surgery and one day after surgery (if foley remains in place)
Hernia Defect Size After Dissection - Width and Length (cm)
Maximum width and length of the hernia defect following dissection/component separation. "How measured": intra-operative ruler measurement; unit = centimeters.
Time frame: During hernia repair surgery
Anterior Fascial Defect Size When Bridging Required - Width and Length (cm)
If PFC not achieved, the residual anterior defect dimensions at closure. "How measured": intra-op ruler; unit = cm.
Time frame: During hernia repair surgery
Posterior Sheath Defect Size if Not Closed - Width and Length (cm)
If posterior sheath cannot be closed, record dimensions. "How measured": intra-op ruler; unit = cm. Note: posterior bridging does not equal PFC failure.
Time frame: During hernia repair surgery
Reason for Failure to Achieve Primary Fascial Closure - Frequency by Category
Surgeon-reported reason(s) categorized and tallied (e.g., excessive tension, loss of domain, patient instability). "How measured": operative note; unit = participants per category (%).
Time frame: During hernia repair surgery
Not Extubated at Case Conclusion - Proportion of Participants (%)
Participants still intubated at the end of the operation. "How measured": anesthesia record; unit = participants (%).
Time frame: Immediately after hernia repair surgery
Immediate Post-operative ICU Admission - Proportion of Participants (%)
Direct transfer to ICU from OR/PACU after surgery. "How measured": disposition orders; unit = participants (%).
Time frame: Immediately after hernia repair surgery
Unplanned ICU Admission Post-operatively - Proportion of Participants (%)
ICU transfer after initial non-ICU disposition. "How measured": bed movement logs/orders; unit = participants (%).
Time frame: Immediately after hernia repair surgery
Total Direct Hospital Cost Through 90 Days - US Dollars (USD)
All-cause direct costs during the surgical global period (90 days). "How measured": institutional cost accounting; unit = USD.
Time frame: 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.
Days Between Injection and Surgery - Days
Interval from image-guided injection to operative date. "How measured": scheduling records; unit = days. (Target window 21-48 days.)
Time frame: Immediately after hernia repair surgery
Plan to share: No — Patients will not be consented for the sharing of individual participant data outside of the Cleveland Clinic.
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2027, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Botulinum toxin type A