Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT04815707

Treatment of Occult Inguinal Hernias

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

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
252 (actual)
Sponsor
The University of Texas Health Science Center, Houston · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREOcccult hernia repairThe occult hernia will be repaired during the same inguinal hernia repair

Timeline

Start date
2021-10-22
Primary completion
2026-10-01
Completion
2026-10-01
First posted
2021-03-25
Last updated
2026-02-17

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04815707. Inclusion in this directory is not an endorsement.