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NCT Number: NCT04815707

Treatment of Occult Inguinal Hernias

Inguinal hernias are a common surgical problem. Best management of occult inguinal hernias, defined as hernias unable to be felt on physical exam, is unknown. From prior studies we know that most inguinal hernias will eventually become symptomatic and require surgery (70%). However, doing a repair on a very small, occult hernia may open the patient up to surgical complications, like chronic pain, earlier than necessary. This will be a multi-center randomized controlled trial of surgical repair versus expectant management of occult inguinal hernias. Patients undergoing laparoscopic unilateral inguinal hernia repair will be included. At the time of surgery, the surgeon will determine if there is an occult hernia contralateral side. If present, patients will be randomized to repair of the occult side or expectant management of the occult side. After 1 year post-operative data has been assessed, a decision tool will be created and administered to patients to aid in their decision making about treatments for their hernia.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lyndon B. Johnson General Hospital, Houston, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Patients undergoing unilateral laparoscopic inguinal hernia repair, found to have a contralateral occult inguinal hernia

Exclusion criteria

  • Patient has life expectancy of less than 2 years
  • Patients unlikely to follow-up (e.g. live out of state, unable to be reached by phone/e-mail
  • Non-English and Non-Spanish speakers
  • Pregnant or breast-feeding patients

Treatment and study plan

Occcult hernia repair

Procedure

The occult hernia will be repaired during the same inguinal hernia repair

Primary outcomes

  1. Patient threshold value for need for future surgery in order to accept Expectant Management (EM) of an Occult Inguinal Hernia (OIH) determined using standard gamble technique

    Time frame: From Baseline up to 2 years post-operative

    Assessed by using a decision tool (standard gamble method) that will be developed using information gathered at 1 year post-operative

Secondary outcomes

  1. Number of patients who develop any surgical complication

    Time frame: 30 days post-operative

    Includes: Wound complications (e.g. SSI, seroma, hematoma, wound dehiscence), complications with the mesh, and hospital readmissions

  2. Hernia recurrence

    Time frame: 2 years post-operative

    recurrence of hernia

  3. Operative re-intervention

    Time frame: 1 years post-operative

    Number of patients who had to have another surgery to repair their hernia

  4. Assessment of chronic pain

    Time frame: 1 year post-operative

    Pain assessed by a validated visual assessment score

  5. Progression of hernia signs or symptoms

    Time frame: 1 year post-operative

    Will be assessed by the physician during the 1 year post-operative abdominal exam visit

  6. Change in Abdominal wall quality of life (AW-QOL)

    Time frame: From Baseline up to 2 years post-operative

    Hernia-related Quality of Life Survey (HerQLes) will be used to assess this. Consists of 12 statements that the patient will rate how much he/she agrees with each statement. They will rate each statement from 1 (Strongly Disagree) to 10 (strongly agree). These 12 ratings will be combined to form one score.

  7. Number of patients with an occult inguinal hernia

    Time frame: Time of surgery

    Prevalence of patients found to have an occult inguinal hernia during their initial inguinal surgery

  8. Groin pain on occult hernia side

    Time frame: 1 month and 1 year post-operative

    Pain assessed by a validated visual assessment score

  9. Time duration for surgery

    Time frame: Time of surgery

    Assessed by looking at the total time for the surgery to repair the inguinal hernia(s)

  10. Time off work due to the hernia surgery

    Time frame: Baseline to 2 years post-operative

    The amount of time (days) patients had to take time off from work for the hernia surgery

  11. Time to resume normal activity from any hernia surgery

    Time frame: Baseline to 2 years post-operative

    The amount of time (days) it took for patients to resume their normal activities following hernia surgery

  12. Satisfaction with Decision Scale

    Time frame: Baseline to 2 years post-operative

    A decision scale looking at risk vs. benefit of hernia surgery will be done with patients

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Surgical Repair Versus Expectant Management of Occult Inguinal Hernias: Strengthening the Evidence Base and Developing a Decision Tool

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2021
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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