Clinical Trial Radar

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.

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 (%).

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 (%).

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 (%).

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 (%).

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 (%).

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.

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 (%).

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)

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 (%).

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 (%).

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 (%).

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 (%).

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.

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).

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.

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 (%).

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 (%).

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 (%).

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.

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/.

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 (%).

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 (%).

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.

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).

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 (%).

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 (%).

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 (%).

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 (%).

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 (%).

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.

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.

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.

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).

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 (%).

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 (%).

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 (%).

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 (%).

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 (%).

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.

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.

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.

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).

Approximately 2 year after hernia repair surgery