Watchful waiting versus immediate repair for a hidden hernia on the other side of the groin
WATCH IT TRIAL WAtchful Waiting Versus immediaTe Repair for Occult Contralateral Hernias Found During MIS Inguinal Hernia Repair Trial.
NA · Northwestern University · NCT07461558
This trial will test whether fixing a small, hidden hernia found on the opposite side during minimally invasive groin hernia surgery or leaving it alone is better for adults having unilateral symptomatic inguinal hernia repair.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07461558 on ClinicalTrials.gov |
What this trial studies
This is a randomized, non-inferiority trial comparing immediate repair to watchful waiting when an occult contralateral inguinal hernia is discovered during minimally invasive unilateral hernia repair. Patients are randomized intraoperatively and followed at 30 days, 1 year, and 2 years to compare recovery, quality of life, and the need for later surgery. The primary short-term outcome is 30-day quality of life, and the watchful waiting arm will capture any hernia-related complications or subsequent repairs. The trial is led by Northwestern with procedures performed at participating surgical centers.
Who should consider this trial
Good fit: Adults aged 18 or older having minimally invasive surgery for a symptomatic unilateral inguinal hernia who are found during the operation to have an occult contralateral inguinal hernia and can provide informed consent.
Not a fit: Patients with symptomatic bilateral hernias on exam, prior contralateral hernia repair, urgent presentations, contraindications to anesthesia or surgery, pregnant patients, or those unable or unwilling to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could reduce unnecessary immediate repairs and lower the risk of additional surgery or long-term groin pain by supporting a safe watchful waiting approach, or alternatively justify immediate repair to prevent future operations.
How similar studies have performed: There is no level 1 randomized evidence on this question; observational series and surgeon opinion are mixed with some data suggesting immediate repair prevents reoperation but concerns remain about repair-related chronic pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients ≥18 years old * Symptomatic unilateral inguinal hernia * Occult contralateral hernia identified intraoperatively * Ability to provide informed consent Exclusion Criteria: * Prior contralateral inguinal hernia repair * Symptomatic, bilateral inguinal hernias confirmed on physical exam * Contraindications to general anesthesia or surgery * Urgent or emergent presentations * Adults unable to consent * Pregnant patients
Where this trial is running
Chicago, Illinois
- Northwestern Memorial Hospital — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Megan S Melland-Smith, MD
- Email: megan.mellandsmith@nm.org
- Phone: 3129071414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inguinal Hernia Bilateral, Inguinal Hernia Unilateral, Occult inguinal hernia, Asymptomatic inguinal hernia, Minimally invasive inguinal hernia repair, Transabdominal preperitoneal inguinal hernia repair