NCT04815707

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for phase_2

Timeline
2mo left

Started Oct 2021

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Oct 2021Oct 2026

First Submitted

Initial submission to the registry

March 2, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 22, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

March 2, 2021

Last Update Submit

February 11, 2026

Conditions

Inguinal Hernia

Outcome Measures

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

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

    From Baseline up to 2 years post-operative

Secondary Outcomes (12)

  • Number of patients who develop any surgical complication

    30 days post-operative

  • Hernia recurrence

    2 years post-operative

  • Operative re-intervention

    1 years post-operative

  • Assessment of chronic pain

    1 year post-operative

  • Progression of hernia signs or symptoms

    1 year post-operative

  • +7 more secondary outcomes

Study Arms (2)

Surgery

OTHER

Occult hernia found will be repaired at the same time as the initial inguinal hernia

Procedure: Occcult hernia repair

Expectant Management

NO INTERVENTION

No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery

Interventions

Occcult hernia repairPROCEDURE

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

Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

Memorial Hermann Hospital-MIST Clinics

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery-Clinical

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 25, 2021

Study Start

October 22, 2021

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

US(2)