Determining the Minimum Clinically Important Difference for the European Hernia Society Quality of Life Instrument in Inguinal Hernia Repair Patients.
Priya Shukla, Li-Ching Huang, Alison Zhao...
https://pubmed.ncbi.nlm.nih.gov/37171090Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07461558
WATCH IT Trial: Watchful Waiting Versus Immediate Repair for Hidden Hernias Found During Minimally Invasive Groin Hernia Surgery
Led by Northwestern University · Updated on 2026-03-10
380
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two approaches for managing a small, hidden hernia found during minimally invasive surgery to repair a known hernia on one side of the groin. This study focuses on whether it is better to repair the hidden hernia immediately during the same operation or to monitor it over time since it may not cause symptoms. There is uncertainty among surgeons about the best option because immediate repair might prevent future problems but also carries risks like long-term pain. Participants who have a hidden hernia discovered during surgery will be randomly assigned to one of two groups. One group will receive immediate repair of the hidden hernia using a laparoscopic technique with mesh after fixing the known hernia. The other group will have only the known hernia repaired, leaving the hidden hernia alone, and will be monitored for any future issues. Follow-up visits will occur at 30 days, 1 year, and 2 years to track outcomes and any need for later surgery. During the study, participants will have their recovery and quality of life assessed at 30 days post-surgery and over the following 2 years. The researchers will record if the hidden hernia causes symptoms or requires surgery in the monitoring group. They will also evaluate complications, pain, readmissions, opioid use, hernia recurrence, and cost effectiveness. This detailed follow-up aims to help doctors and patients make informed decisions about managing hidden hernias found during surgery.
CONDITIONS
Brief Title
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years or older
- Symptomatic unilateral inguinal hernia
- Hidden hernia on the opposite side found during surgery
- Ability to provide informed consent
You will not qualify if you...
- Prior surgery to repair an inguinal hernia on the opposite side
- Symptomatic hernias on both sides confirmed by exam
- Cannot have general anesthesia or surgery
- Urgent or emergency hernia cases
- Adults unable to consent
- Pregnant patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day plus 30 days post-operative period
Participants undergo minimally invasive unilateral inguinal hernia repair. If an occult hernia is found, participants are randomized to either immediate repair of the occult hernia or watchful waiting. Immediate repair involves additional TAPP repair with mesh placement during the initial surgery.
1 surgery visit and follow-up visits up to 30 days postoperatively
Post-operative Follow-up
Duration - Up to 2 years
Participants are followed to assess quality of life, hernia-related complications, wound complications, readmissions, medical complications, reoperations, opioid use, hernia recurrence, and chronic groin pain over time.
Follow-up visits at 30 days, 1 year, and 2 years post-surgery
Trial Site Locations
Total: 1 location
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
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Research Team
M
Megan S Melland-Smith, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Quality of life outcomes of minimally invasive repair of occult contralateral inguinal hernias: an ACHQC analysis.
Shemiele A Lewis, Li Ching Huang, Mazen R Al-Mansour
https://pubmed.ncbi.nlm.nih.gov/40789772Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias.
Robert J Fitzgibbons, Bala Ramanan, Shipra Arya...
https://pubmed.ncbi.nlm.nih.gov/24022443Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial.
Robert J Fitzgibbons, Anita Giobbie-Hurder, James O Gibbs...
https://pubmed.ncbi.nlm.nih.gov/16418463To repair or not to repair incidental defects found on laparoscopic repair of groin hernia: early results of a randomized control trial.
V K Thumbe, D S Evans
https://pubmed.ncbi.nlm.nih.gov/11178762Research prioritization in hernia surgery: a modified Delphi ACHQC and VHOC expert consensus.
Daphne Remulla, Mazen R Al-Mansour, Christopher Schneider...
https://pubmed.ncbi.nlm.nih.gov/39190257Contralateral exploration and repair of occult inguinal hernias during laparoscopic inguinal hernia repair: systematic review and Markov decision process.
N H Dhanani, O A Olavarria, S Wootton...
https://pubmed.ncbi.nlm.nih.gov/33688950The incidence and natural course of occult inguinal hernias during TAPP repair: repair is beneficial.
Baukje van den Heuvel, Nikki Beudeker, Joris van den Broek...
https://pubmed.ncbi.nlm.nih.gov/23708722International guidelines for groin hernia management.
HerniaSurge Group
https://pubmed.ncbi.nlm.nih.gov/29330835Hernias: inguinal and incisional.
Andrew Kingsnorth, Karl LeBlanc
https://pubmed.ncbi.nlm.nih.gov/14615114