Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07461558
Brief Summary:
This study will compare two ways of managing a small, hidden hernia that can sometimes be found during minimally invasive surgery to repair a hernia on one side of the groin. Occasionally while fixing the known hernia, the surgeon discovers a small hernia on the other side that has not caused any symptoms. Surgeons do not agree on the best way to handle these hernias. Some believe it should be repaired right away during the same operation to prevent it from getting bigger or from causing symptoms later, which could require another surgery. Others believe it is better to leave it alone since it is not causing problems and groin hernia surgery carries risks including long-term pain.
This study will randomly assign patients, if a hidden hernia is found during surgery, to either having it repaired immediately or to have it monitored over time. Patients will be followed up at 30 days, 1 year and 2 years following surgery. The researchers will compare recovery and quality of life between the two groups. For those in the monitoring group, the study will also track whether the hidden hernia causes symptoms or eventually needs surgery. The goal is to determine whether repairing the hidden hernia right away is as safe and effective as watching and waiting, so doctors and patients can make more informed decisions in the future.
Detailed Description:
This is a multicenter randomized controlled trial evaluating two management strategies - watchful waiting versus immediate repair - for occult contralateral inguinal hernias discovered during minimally invasive unilateral inguinal hernia repair. The management of occult inguinal hernias discovered at the time of laparoscopic inguinal hernia repair remains controversial. Many surgeons advocate for immediate repair during the index operation as this prevents reoperation as patients risk hernia progression and developing symptoms in the future. Others refrain from repair given that this occult hernia is asymptomatic and does not justify the risk of complications, including chronic pain, associated with repair. Currently there is no level 1 evidence to guide decision making for immediate repair versus watchful waiting. We plan to conduct at randomized, multi-center, non-inferiority trial to establish if immediate repair is non-inferior to watchful waiting in short term 30-day quality of life. Patients will be randomized intraoperatively once an occult contralateral inguinal hernia is identified. Patients will be followed up at 30-day, 1 and 2 years. In the watchful waiting group, occult hernia-related complications and those requiring repair will be captured.
Study:
NCT07461558
Study Brief:
Protocol Section:
NCT07461558