Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.

NCT07461558 | Recruiting DMC

• 1 other identifier: STU00225342
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia Bilateral; Inguinal Hernia Unilateral

Keywords

Occult inguinal hernia; Asymptomatic inguinal hernia; Minimally invasive inguinal hernia repair; Transabdominal preperitoneal inguinal hernia repair

Outcome Measures

Primary Outcomes (1)

• 30-day (±15) post-operative quality of life

  At 30 days postoperatively, patients will see their operating surgeon and will undergo a physical exam and complete a EuraHS survey as is standard of care. The EuraHS Quality of Life Score, validated for inguinal hernia patients, allows quantification of pain, physical restriction, and cosmetic satisfaction-domains directly affected by surgical intervention.

  30 days postoperatively

Secondary Outcomes (8)

• Rate of occult hernias that require repair as well as occult hernia related emergencies.

  2 years

• Changes in quality of life over time as measured by EuraHS at 1 year, and 2 years.

  2 years

• Difference in rate of wound complications at 30-days (±15) following surgery.

  30-days

• Evaluate differences in readmissions, medical complications, and reoperations at 30 (± 15) days, 1 and 2 years.

  2 years

• Evaluate differences in post-operative opioid prescribing and opioid consumption at 30 (± 15) days.

  30 days

Study Arms (2)

Immediate occult hernia repair group

ACTIVE COMPARATOR

Patients who are randomized to immediate occult hernia repair will undergo TAPP hernia repair with mesh of their occult inguinal hernia following repair of their symptomatic inguinal hernia.

Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Watchful waiting occult hernia group

ACTIVE COMPARATOR

Patients randomized to the watchful waiting group will undergo standard transabdominal preperitoneal inguinal hernia repair with mesh of their symptomatic hernia. Their occult hernia will be left alone.

Procedure: Watchful waiting with supportive care

Interventions

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines PROCEDURE

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.

Immediate occult hernia repair group

Watchful waiting with supportive care PROCEDURE

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.

Watchful waiting occult hernia group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.

  PMID: 29330835 BACKGROUND

• Kingsnorth A, LeBlanc K. Hernias: inguinal and incisional. Lancet. 2003 Nov 8;362(9395):1561-71. doi: 10.1016/S0140-6736(03)14746-0.

  PMID: 14615114 BACKGROUND

MeSH Terms

Interventions

Surgical Procedures, Operative; Watchful Waiting; Palliative Care

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nancy Ly, MD

  Northwestern University

  STUDY DIRECTOR

Central Study Contacts

Megan S Melland-Smith, MD

CONTACT

3129071414; megan.mellandsmith@nm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We will enroll all adult patients with a unilateral symptomatic inguinal hernia who are suitable for a minimally invasive inguinal hernia repair. Once in the operating room and pneumoperitoneum is established, patients identified to have an occult contralateral inguinal hernia will be kept in the study. Those patients consented but without an occult inguinal hernia will be removed from the study at that point and considered screen failures.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: June 26, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)