Standardized Surgical Care for Abdominal Hernia

Overseen By Alexander Hallway

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Not in MSQC-COHR

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how hospitals follow guidelines for repairing abdominal hernias, which occur when an organ pushes through the abdominal wall. The study tests two methods: a standard program called Replicating Effective Programs (REP) and an enhanced version with extra support, called REP-PLUS. Hospitals in the Michigan Surgical Quality Collaborative participate in this research, focusing on finding the best ways to assist hospitals that struggle to meet guidelines. Only hospitals in this specific collaborative can join the trial.

As an unphased trial, this study provides a unique opportunity to enhance hospital practices and patient outcomes.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this protocol is safe for improving hernia care?

Research has shown that the Replicating Effective Programs (REP) treatment is generally well-tolerated. Studies on hernia repair methods have reported low rates of complications and recurrence. For the REP with facilitation (REP-PLUS) treatment, previous research on similar surgeries, such as hernia repairs, indicates it is usually low-risk. Only a small number of patients experienced complications within 30 days after surgery.

These findings suggest that both REP and REP-PLUS treatments are safe in similar surgical situations. Participants considering joining a trial can feel reassured by this existing evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance surgical care for abdominal hernias by using two approaches: Replicating Effective Programs (REP) and REP with facilitation (REP-PLUS). Unlike traditional hernia treatments that rely primarily on surgical techniques, this trial focuses on improving the adherence to best practice guidelines across hospitals. REP-PLUS is particularly intriguing because it adds a layer of facilitation to help non-responding hospitals meet guideline adherence. By exploring these methods, researchers hope to discover if tailored support can significantly improve surgical outcomes in hernia care.

What evidence suggests that this trial's treatments could be effective for improving adherence to hernia care guidelines?

Studies have shown that the Replicating Effective Programs (REP) method, one approach evaluated in this trial, can improve surgical care for abdominal hernias through clear guidelines. This method has led to better patient outcomes and safer hernia repairs. In this trial, some hospitals will receive REP with extra support (REP-PLUS). Research indicates that REP-PLUS can further enhance results by providing additional help and resources. Outcomes from similar programs have shown fewer hernia recurrences and complications, such as infections. These methods aim to make surgeries safer and more effective by ensuring hospitals follow proven guidelines. ^{3 4 6 7 8}

Who Is on the Research Team?

Anne Ehlers, MD, MPH

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for hospitals within the Michigan Surgical Quality Collaborative Hernia Registry. It's focused on improving adherence to guidelines for abdominal wall hernia repair. Hospitals that are underperforming in terms of quality measures will be included, while those not part of the registry or unable to implement changes may be excluded.

Inclusion Criteria

All hospitals that participate in MSQC-COHR will be eligible to participate in the trial

Exclusion Criteria

Institutes that are not in the MSQC-COHR

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Program (REP)

All sites participate in the baseline REP program to improve adherence to guidelines

12 months

Stage 1 Randomization

Non-responders to the baseline program are randomized to REP or REP-PLUS

12 months

Stage 2 Randomization

Non-responders from Stage 1 are re-randomized to REP or REP-PLUS; responders continue with their assigned program

12 months

Follow-up

Participants are monitored for adherence to clinical practice guidelines

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Replicating Effective Programs (REP)
• REP with facilitation (REP-PLUS)

Trial Overview The trial tests a program called REP-PLUS, which aims to help hospitals follow best practices for hernia surgery more closely. It uses a special kind of study design (SMART) to adjust strategies based on how well sites are doing during the trial.

How Is the Trial Designed?

Group I: Replicating Effective Programs (REP) - stage 1 randomized group Experimental Treatment 1 Intervention

Non-responder to the initial baseline program of MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) randomized to this arm. This randomized arm will be evaluated over 12 months.

Group II: Replicating Effective Programs (REP) - baseline program non-randomized Experimental Treatment 1 Intervention

All sites participating will be given this REP. This will be evaluated over 12 months.

Group III: Replicating Effective Programs (REP) (responders)- stage 2 randomized group Experimental Treatment 1 Intervention

This group will include the REP-PLUS responders from stage 1. The responding hospitals will that are re-randomized to this group will receive REP alone.

Group IV: Replicating Effective Programs (REP) (non-responders) - stage 2 randomized group Experimental Treatment 1 Intervention

Twelve months after the stage 1, non-responder MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) that were assigned to the REP arm will be re-randomized to this arm or REP-PLUS. This randomized arm will be evaluated over 12 months.

Group V: REP-PLUS (responders) - stage 2 randomized group Experimental Treatment 1 Intervention

This group will include the REP-PLUS responders from stage 1. The responding hospitals will that are re-randomized to this group will continue to receive REP-PLUS.

Group VI: REP with facilitation (REP-PLUS) - stage 1 randomized group Experimental Treatment 1 Intervention

Non-responders to the initial baseline program of REP MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) randomized to this arm. This randomized arm will be evaluated over 12 months.

Group VII: REP with facilitation (REP-PLUS) (non-responders) - stage 2 randomized group Experimental Treatment 1 Intervention

Twelve months after the stage 1, non-responder MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) that were assigned to the REP arm will be re- randomized to this arm REP-PLUS or REP alone. This randomized arm will be evaluated over 12 months.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9115612/

Comparison of Outcomes of Abdominal Wall ... The primary outcome was hernia recurrence. Secondary outcomes were surgical site occurrence, surgical site infection, length of hospital stay, ...

2. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2022/07000/favorable_outcomes_after_retro_rectus.9.aspx

Favorable outcomes after retro-rectus (rives-stoppa) mesh ... Retro-rectus (Rives-Stoppa) repair results in excellent outcomes, superior or similar to other techniques for all outcomes except SSI.

3. nature.com nature.com/articles/s41598-025-87555-x

Comparative analysis of efficacy and quality of life between ... Data collection encompassed operation time, postoperative complications, recovery status, quality of life (assessed using the Hernia-Related ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8561332/

Outcomes of a Presurgical Optimization Program for ... In this quality improvement study, 1 year after the implementation of a preoperative optimization clinic, 9.1% of high-risk patients became ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2779779

Preoperative Optimization for High-Risk Patients With ... In this quality improvement study including 23 000 patients, preoperative optimization for high-risk patients with abdominal wall hernia varied from 20% to 53% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12246025/

Transabdominal pre-peritoneal hernia repair: risk of operation ... Inguinal hernia repair is among the most commonly performed surgical procedures worldwide [1–3]. It is considered a low-risk procedure with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S000296102300257X

Ventral hernia repair with concurrent intra-abdominal surgery In all, 185 (0.3%) patients suffered a complication with deadly outcome during the 30 days after surgery. Table 1. Patient data for index surgical admission.

8. frontierspartnerships.org frontierspartnerships.org/journals/journal-of-abdominal-wall-surgery/articles/10.3389/jaws.2025.15008/full

Outcomes During the Learning Curve and Feasibility of ... We aimed to demonstrate the impact on patient outcomes and safety of hernia repair by adhering to the robotic abdominal wall surgery pathway ...