Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.

Официальное название

WATCH IT TRIAL WAtchful Waiting Versus immediaTe Repair for Occult Contralateral Hernias Found During MIS Inguinal Hernia Repair Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
  Patients in the immediate occult hernia repair arm will under TAPP repair with placement of mesh of their occult inguinal hernia following repair of their symptomatic inguinal hernia.
• Процедура Watchful waiting with supportive care
  Patients in the watchful waiting group will undergo standard TAPP inguinal hernia repair with mesh of their symptomatic hernia. Their occult hernia will be left alone. These patients will be followed postoperatively for occult hernia related emergencies including incarceration, strangulation or obstruction.

Первичные конечные точки

• 30-day (±15) post-operative quality of life [Срок оценки: 30 days postoperatively]

Вторичные конечные точки (8)

• Rate of occult hernias that require repair as well as occult hernia related emergencies. [Срок оценки: 2 years]
• Changes in quality of life over time as measured by EuraHS at 1 year, and 2 years. [Срок оценки: 2 years]
• Difference in rate of wound complications at 30-days (±15) following surgery. [Срок оценки: 30-days]
• Evaluate differences in readmissions, medical complications, and reoperations at 30 (± 15) days, 1 and 2 years. [Срок оценки: 2 years]
• Evaluate differences in post-operative opioid prescribing and opioid consumption at 30 (± 15) days. [Срок оценки: 30 days]
• Evaluate difference in inguinal hernia recurrence at 1and 2 years following surgery. [Срок оценки: 2 years]
• Evaluate chronic groin pain at 1 and 2 years using the pain domain of the EuraHS score. [Срок оценки: 2 years]
• Perform a formal cost effectiveness analysis utilizing incremental cost effectiveness ratios. [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Male or female patients ≥18 years old
• Symptomatic unilateral inguinal hernia
• Occult contralateral hernia identified intraoperatively
• Ability to provide informed consent

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Northwestern Memorial Hospital — Chicago

Публикации

• Shukla P, Huang LC, Zhao A, Sharew B, Miller B, Beffa L, Petro CC, Krpata DM, Prabhu AS, Rosen MJ. Determining the Minimum Clinically Important Difference for the European Hernia Society Quality of Life Instrument in Inguinal Hernia Repair Patients. J Am Coll Surg. 2023 Sep 1;237(3):525-532. doi: 10.1097/XCS.0000000000000754. Epub 2023 May 12. PMID 37171090
• Lewis SA, Huang LC, Al-Mansour MR. Quality of life outcomes of minimally invasive repair of occult contralateral inguinal hernias: an ACHQC analysis. Surg Endosc. 2025 Oct;39(10):6793-6801. doi: 10.1007/s00464-025-12060-1. Epub 2025 Aug 11. PMID 40789772
• Fitzgibbons RJ Jr, Ramanan B, Arya S, Turner SA, Li X, Gibbs JO, Reda DJ; Investigators of the Original Trial. Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg. 2013 Sep;258(3):508-15. doi: 10.1097/SLA.0b013e3182a19725. PMID 24022443
• Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, Dunlop DD, Reda DJ, McCarthy M Jr, Neumayer LA, Barkun JS, Hoehn JL, Murphy JT, Sarosi GA Jr, Syme WC, Thompson JS, Wang J, Jonasson O. Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA. 2006 Jan 18;295(3):285-92. doi: 10.1001/jama.295.3.285. PMID 16418463
• Thumbe VK, Evans DS. To repair or not to repair incidental defects found on laparoscopic repair of groin hernia: early results of a randomized control trial. Surg Endosc. 2001 Jan;15(1):47-9. doi: 10.1007/s004640000254. PMID 11178762
• Remulla D, Al-Mansour MR, Schneider C, Phillips S, Hope WW, Bradley Iii JF, Pierce RA, Arias-Espinosa L, Bernardi K, Holihan JL, Loor M, Liang MK, Miller BT. Research prioritization in hernia surgery: a modified Delphi ACHQC and VHOC expert consensus. Hernia. 2024 Dec;28(6):2217-2222. doi: 10.1007/s10029-024-03139-0. Epub 2024 Aug 27. PMID 39190257
• Dhanani NH, Olavarria OA, Wootton S, Petsalis M, Lyons NB, Ko TC, Kao LS, Liang MK. Contralateral exploration and repair of occult inguinal hernias during laparoscopic inguinal hernia repair: systematic review and Markov decision process. BJS Open. 2021 Mar 5;5(2):zraa020. doi: 10.1093/bjsopen/zraa020. PMID 33688950
• van den Heuvel B, Beudeker N, van den Broek J, Bogte A, Dwars BJ. The incidence and natural course of occult inguinal hernias during TAPP repair: repair is beneficial. Surg Endosc. 2013 Nov;27(11):4142-6. doi: 10.1007/s00464-013-3008-2. Epub 2013 May 25. PMID 23708722

Идентификаторы

NCT: NCT07461558 · STU00225342

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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