Treatment of Occult Inguinal Hernias

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04815707
• Other study ID #: HSC-MS-20-1327
• Secondary ID: KL2TR003168
• Status: Recruiting
• Phase: Phase 2
• Start date: October 22, 2021
• Est. completion date: October 2025

Study information

• Verified date: June 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Julie Holihan, MD
• Phone: 713-500-7188
• Email: Julie.L.Holihan[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Occcult hernia repair
The occult hernia will be repaired during the same inguinal hernia repair

Locations

Country	Name	City	State
United States	Lyndon B. Johnson General Hospital	Houston	Texas
United States	Memorial Hermann Hospital-MIST Clinics	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients who develop any surgical complication	Includes: Wound complications (e.g. SSI, seroma, hematoma, wound dehiscence), complications with the mesh, and hospital readmissions	30 days post-operative
Secondary	Hernia recurrence	recurrence of hernia	2 years post-operative
Secondary	Operative re-intervention	Number of patients who had to have another surgery to repair their hernia	1 years post-operative
Secondary	Assessment of chronic pain	Pain assessed by a validated visual assessment score	1 year post-operative
Secondary	Progression of hernia signs or symptoms	Will be assessed by the physician during the 1 year post-operative abdominal exam visit	1 year post-operative
Secondary	Change in Abdominal wall quality of life (AW-QOL)	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.	From Baseline up to 2 years post-operative
Secondary	Number of patients with an occult inguinal hernia	Prevalence of patients found to have an occult inguinal hernia during their initial inguinal surgery	Time of surgery
Secondary	Groin pain on occult hernia side	Pain assessed by a validated visual assessment score	1 month and 1 year post-operative
Secondary	Time duration for surgery	Assessed by looking at the total time for the surgery to repair the inguinal hernia(s)	Time of surgery
Secondary	Time off work due to the hernia surgery	The amount of time (days) patients had to take time off from work for the hernia surgery	Baseline to 2 years post-operative
Secondary	Time to resume normal activity from any hernia surgery	The amount of time (days) it took for patients to resume their normal activities following hernia surgery	Baseline to 2 years post-operative
Secondary	Satisfaction with Decision Scale	A decision scale looking at risk vs. benefit of hernia surgery will be done with patients	Baseline to 2 years post-operative