380 Participants NeededMy employer runs this trial

Watchful Waiting vs Immediate Repair for Inguinal Hernia

(WATCH IT Trial)

MS
Overseen ByMegan S Melland-Smith, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks the best approach for managing a small, hidden hernia discovered during surgery for a noticeable groin hernia. It compares two options: immediately repairing the hidden hernia or monitoring it (watchful waiting) to see if it causes future issues. Individuals with a noticeable inguinal hernia who discover a hidden one during surgery may be suitable for this trial. The trial aims to determine which method leads to better recovery and quality of life, aiding doctors and patients in making informed decisions. As an unphased trial, it offers patients the chance to contribute to medical knowledge that could enhance hernia treatment strategies.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that repairing an inguinal hernia (a bulge in the groin area) with mesh is generally safe and has a low recurrence rate. One study found that only 5% of hernias returned over five years, indicating that most people recover well after surgery. Another study indicated that using mesh in hernia repair reduces the chances of recurrence compared to repairs without mesh. Although complications such as infections or issues with the mesh can occur, they are uncommon. Overall, these findings suggest that immediate hernia repair with mesh is well-tolerated and generally safe.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring the potential of "watchful waiting" as a management strategy for inguinal hernias compared to immediate repair. Unlike the standard practice of promptly surgically repairing both symptomatic and occult hernias, this approach allows for the non-symptomatic hernia to be left alone in certain patients, focusing only on repairing the symptomatic one. This could mean fewer surgeries and potentially less risk for patients, offering a more tailored approach to treatment. By comparing these two strategies, researchers hope to determine if immediate repair is always necessary or if a less invasive approach might be just as effective, which could change how hernias are managed in the future.

What evidence suggests that this trial's treatments could be effective for managing hidden inguinal hernias?

This trial will compare two approaches for managing inguinal hernias: immediate repair and watchful waiting. Research has shown that fixing a hernia with a small camera and tools (called laparoscopic surgery) often results in fewer hernias recurring and faster recovery compared to traditional open surgery. One study found that only about 1% of patients who underwent this type of surgery experienced a hernia recurrence. These less invasive methods also typically cause less post-surgery pain. However, another study suggested that simply monitoring the hernia, instead of fixing it immediately, is safe. This approach, known as watchful waiting, often delays the need for surgery rather than preventing it. Both immediate surgery and watchful waiting offer advantages, depending on the situation. Participants in this trial will be randomized to either the immediate repair group or the watchful waiting group to evaluate these approaches.678910

Who Is on the Research Team?

NL

Nancy Ly, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

Inclusion Criteria

Ability to provide informed consent
I am 18 years old or older.
I have symptoms from a hernia on one side of my groin.
See 1 more

Exclusion Criteria

I cannot safely have general anesthesia or surgery.
Urgent or emergent presentations
I am an adult who cannot give consent for myself.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo minimally invasive surgery for symptomatic inguinal hernia repair. If an occult hernia is found, they are randomized to either immediate repair or watchful waiting.

Immediate (during surgery)
1 visit (in-person)

Follow-up

Participants are monitored for recovery, quality of life, and complications at 30 days, 1 year, and 2 years post-surgery.

2 years
3 visits (in-person)

Long-term monitoring

In the watchful waiting group, the study tracks whether the hidden hernia causes symptoms or eventually needs surgery.

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Watchful Waiting

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Immediate occult hernia repair groupActive Control1 Intervention
Group II: Watchful waiting occult hernia groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Citations

Outcomes of Inguinal Hernia Repair Over Five Years in ... - PMC

Laparoscopic repair demonstrated a lower recurrence rate (n = 2/188, 1.08%) compared with open repair (n = 18/712, 2.5%). Higher recurrence rates were observed ...

The Pros and Cons of Minimally Invasive Surgery Versus ...

This method offers several advantages over open surgery, including reduced postoperative pain, quicker recovery times, and fewer wound ...

Shorter operative times following robotic-assisted ...

based on 19 studies and a total of 8987 patients demonstrated that robotic-assisted inguinal hernia repair was associated with longer operative ...

Outcomes of treatment for recurrent inguinal hernia

This study examines the outcomes of recurrent inguinal hernia surgeries and the patient factors influencing the choice of surgical technique.

Effect of Early vs Late Inguinal Hernia Repair on Serious ...

Among preterm infants with inguinal hernia, the late repair strategy resulted in fewer infants having at least 1 serious adverse event.

Outcomes after elective inguinal hernia repair with mesh ...

This 5-year follow-up study of patients who were operated on with mesh repair for inguinal hernias showed an overall recurrence rate of 5.0% and ...

Minimally Invasive Inguinal Hernia Repair - StatPearls - NCBI

Successful outcomes depend on precise knowledge of preperitoneal anatomy, careful dissection to protect neurovascular structures, and ...

Recurrence and Mesh Use After Emergency Ventral Hernia ...

Among emergent open repairs, those repaired with mesh had significantly lower 10-year recurrence rates than those repaired without mesh (13.0% ...

Outcomes of 207 totally extraperitoneal hernia repairs ...

IH repair using the TEP technique and self-fixation mesh showed to be an excellent approach, demonstrating satisfactory results in follow up and complications.

Mesh Fixation Methods in Laparoscopic Hernia Repair ...

This study is a clinical trial that aims to compare three different methods for securing a surgical mesh during a specific type of groin (inguinal) hernia ...