Clinical trial NCT04815707: Treatment of Occult Inguinal Hernias
Official title: Surgical Repair Versus Expectant Management of Occult Inguinal Hernias: Strengthening the Evidence Base and Developing a Decision Tool
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Inguinal Hernia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-03-25
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: From Baseline up to 2 years post-operative
Secondary outcomes:
measure: Number of patients who develop any surgical complication
timeFrame: 30 days post-operative
measure: Hernia recurrence
timeFrame: 2 years post-operative
measure: Operative re-intervention
timeFrame: 1 years post-operative
measure: Assessment of chronic pain
timeFrame: 1 year post-operative
measure: Progression of hernia signs or symptoms
timeFrame: 1 year post-operative
measure: Change in Abdominal wall quality of life (AW-QOL)
timeFrame: From Baseline up to 2 years post-operative
measure: Number of patients with an occult inguinal hernia
timeFrame: Time of surgery
measure: Groin pain on occult hernia side
timeFrame: 1 month and 1 year post-operative
measure: Time duration for surgery
timeFrame: Time of surgery
measure: Time off work due to the hernia surgery
timeFrame: Baseline to 2 years post-operative
measure: Time to resume normal activity from any hernia surgery
timeFrame: Baseline to 2 years post-operative
measure: Satisfaction with Decision Scale
timeFrame: Baseline to 2 years post-operative
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital-MIST Clinics
state: Texas
Study officials:
References: