Inguinal Hernia BilateralWATCH ITNCT07461558
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines and Watchful waiting with supportive care in people with Inguinal Hernia Bilateral and Inguinal Hernia Unilateral, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
- What is being tested?
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines and Watchful waiting with supportive care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥18 years old
- Symptomatic unilateral inguinal hernia
- Occult contralateral hernia identified intraoperatively
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Megan Melland-Smith, MD, 3129071414, megan.mellandsmith@nm.org
Nancy Ly, MD, 2624551560, nancy.ly@nm.org
About this study
Official title: WATCH IT TRIAL WAtchful Waiting Versus immediaTe Repair for Occult Contralateral Hernias Found During MIS Inguinal Hernia Repair Trial.
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.
Read the 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.
- Being tested
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines, Watchful waiting with supportive care
- Keywords
- Occult inguinal hernia, Asymptomatic inguinal hernia, Minimally invasive inguinal hernia repair, Transabdominal preperitoneal inguinal hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesProcedure or surgery
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.
Watchful waiting with supportive careProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Watchful waiting with supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days postoperatively
Secondary outcomes (8)
Rate of occult hernias that require repair as well as occult hernia related emergencies.
The researchers will assess the rate of occult hernias that require repair as well as occult hernia related emergencies (incarceration, strangulation or obstruction) in the watchful waiting group over the 2 year follow-up period.
Measured: 2 years
Changes in quality of life over time as measured by EuraHS at 1 year, and 2 years.
At 1 and 2 years patients will see their operating surgeon and will undergo a physical exam and EuraHS survey as is standard of care.
Measured: 2 years
Difference in rate of wound complications at 30-days (±15) following surgery.
Wound events are defined as surgical site infection (SSI), surgical site occurrence (SSO) and surgical site occurrence requiring procedural intervention (SSOPI), as defined by the Ventral Hernia Working Group. Wound events will be assessed by physical exam or virtual evaluation at 30 (± 15) days.
Measured: 30-days
Evaluate differences in readmissions, medical complications, and reoperations at 30 (± 15) days, 1 and 2 years.
We will collect rate of readmissions and the cause for readmission as well as any medical complications and reasons for reoperation.
Measured: 2 years
Evaluate differences in post-operative opioid prescribing and opioid consumption at 30 (± 15) days.
At the 30-day follow-up appointment, the researchers will collect number and dose of opioids prescribed as well at opioids consumed in the last 30-days.
Measured: 30 days
Evaluate difference in inguinal hernia recurrence at 1and 2 years following surgery.
Hernia recurrence will be determined using the current consensus score. This includes an algorithm previously described involving evaluation of CT scan, clinical exam, and Ventral Hernia Recurrence Inventory, a validated questionnaire using patient-reported outcomes to determine hernia recurrence after repair.
Measured: 2 years
Evaluate chronic groin pain at 1 and 2 years using the pain domain of the EuraHS score.
Pain scores from the EuraHS will be collected at 1 and 2 years. These scores will be extrapolated to determine on-going pain suggestive of chronic groin pain.
Measured: 2 years
Perform a formal cost effectiveness analysis utilizing incremental cost effectiveness ratios.
Costs will be compared as continuous variables using a student's t-test. Cost data will be obtained from Northwestern and will include direct costs. Direct costs for the index operation will include operating room supply and time, anesthesia, and pharmacy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia BilateralStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Melland-Smith, Northwestern University
- Investigators
- Nancy Ly, MD, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461558
- Sponsor's protocol ID
- STU00225342
- Acronym
- WATCH IT
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared. De-identified data may be available from the study investigators upon reasonable request and with appropriate institutional approvals.
Publications
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.
PubMed 37171090Lewis 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.
PubMed 40789772Fitzgibbons 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.
PubMed 24022443Fitzgibbons 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.
PubMed 16418463Thumbe 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.
PubMed 11178762Remulla 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.
PubMed 39190257Dhanani 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.
PubMed 33688950van 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.
PubMed 23708722HerniaSurge 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.
PubMed 29330835Kingsnorth A, LeBlanc K. Hernias: inguinal and incisional. Lancet. 2003 Nov 8;362(9395):1561-71. doi: 10.1016/S0140-6736(03)14746-0.
PubMed 14615114
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WATCH IT TRIAL WAtchful Waiting Versus immediaTe Repair for Occult Contralateral Hernias Found During MIS Inguinal Hernia Repair Trial.
- ClinicalTrials.gov ID
- NCT07461558
- Acronym / sponsor ID
- WATCH IT / STU00225342
- Keywords
- Occult inguinal hernia, Asymptomatic inguinal hernia, Minimally invasive inguinal hernia repair, Transabdominal preperitoneal inguinal hernia repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate occult hernia repair group | Active comparator | Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesPatients 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. |
| Watchful waiting occult hernia group | Active comparator | Procedure: Watchful waiting with supportive carePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients ≥18 years old
- Symptomatic unilateral inguinal hernia
- Occult contralateral hernia identified intraoperatively
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesPatients 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. | Procedure or surgery | Immediate occult hernia repair group |
| Watchful waiting with supportive carePatients 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. | Procedure or surgery | Watchful waiting occult hernia group |
Primary outcome
30-day (±15) post-operative quality of life
Time frame: 30 days postoperatively
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.
8 secondary outcomes
Rate of occult hernias that require repair as well as occult hernia related emergencies.
Time frame: 2 years
Changes in quality of life over time as measured by EuraHS at 1 year, and 2 years.
Time frame: 2 years
Difference in rate of wound complications at 30-days (±15) following surgery.
Time frame: 30-days
Evaluate differences in readmissions, medical complications, and reoperations at 30 (± 15) days, 1 and 2 years.
Time frame: 2 years
Evaluate differences in post-operative opioid prescribing and opioid consumption at 30 (± 15) days.
Time frame: 30 days
Evaluate difference in inguinal hernia recurrence at 1and 2 years following surgery.
Time frame: 2 years
Evaluate chronic groin pain at 1 and 2 years using the pain domain of the EuraHS score.
Time frame: 2 years
Perform a formal cost effectiveness analysis utilizing incremental cost effectiveness ratios.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 37171090Shukla 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.
- Background: PubMed 40789772Lewis 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.
- Background: PubMed 24022443Fitzgibbons 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.
- Background: PubMed 16418463Fitzgibbons 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.
- Background: PubMed 11178762Thumbe 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.
- Background: PubMed 39190257Remulla 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.
- Background: PubMed 33688950Dhanani 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.
- Background: PubMed 23708722van 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.
- Background: PubMed 29330835HerniaSurge 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.
- Background: PubMed 14615114Kingsnorth A, LeBlanc K. Hernias: inguinal and incisional. Lancet. 2003 Nov 8;362(9395):1561-71. doi: 10.1016/S0140-6736(03)14746-0.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared. De-identified data may be available from the study investigators upon reasonable request and with appropriate institutional approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nancy Ly, MD study director
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines and Watchful waiting with supportive care in people with Inguinal Hernia Bilateral and Inguinal Hernia Unilateral, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan S Melland-Smith, MD (3129071414, megan.mellandsmith@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day (±15) post-operative quality of life (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07461558, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.