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Treatment of Occult Inguinal Hernias

Primary Purpose

Inguinal Hernia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Occcult hernia repair
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lyndon B. Johnson General HospitalRecruiting
  • Memorial Hermann Hospital-MIST ClinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Surgery

Expectant Management

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Hernia recurrence
recurrence of hernia
Operative re-intervention
Number of patients who had to have another surgery to repair their hernia
Assessment of chronic pain
Pain assessed by a validated visual assessment score
Progression of hernia signs or symptoms
Will be assessed by the physician during the 1 year post-operative abdominal exam visit
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.
Number of patients with an occult inguinal hernia
Prevalence of patients found to have an occult inguinal hernia during their initial inguinal surgery
Groin pain on occult hernia side
Pain assessed by a validated visual assessment score
Time duration for surgery
Assessed by looking at the total time for the surgery to repair the inguinal hernia(s)
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
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
Satisfaction with Decision Scale
A decision scale looking at risk vs. benefit of hernia surgery will be done with patients

Full Information

First Posted
March 2, 2021
Last Updated
June 20, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT04815707
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Other
Arm Description
Occult hernia found will be repaired at the same time as the initial inguinal hernia
Arm Title
Expectant Management
Arm Type
No Intervention
Arm Description
No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery
Intervention Type
Procedure
Intervention Name(s)
Occcult hernia repair
Intervention Description
The occult hernia will be repaired during the same inguinal hernia repair
Primary Outcome Measure Information:
Title
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
Description
Assessed by using a decision tool (standard gamble method) that will be developed using information gathered at 1 year post-operative
Time Frame
From Baseline up to 2 years post-operative
Secondary Outcome Measure Information:
Title
Number of patients who develop any surgical complication
Description
Includes: Wound complications (e.g. SSI, seroma, hematoma, wound dehiscence), complications with the mesh, and hospital readmissions
Time Frame
30 days post-operative
Title
Hernia recurrence
Description
recurrence of hernia
Time Frame
2 years post-operative
Title
Operative re-intervention
Description
Number of patients who had to have another surgery to repair their hernia
Time Frame
1 years post-operative
Title
Assessment of chronic pain
Description
Pain assessed by a validated visual assessment score
Time Frame
1 year post-operative
Title
Progression of hernia signs or symptoms
Description
Will be assessed by the physician during the 1 year post-operative abdominal exam visit
Time Frame
1 year post-operative
Title
Change in Abdominal wall quality of life (AW-QOL)
Description
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.
Time Frame
From Baseline up to 2 years post-operative
Title
Number of patients with an occult inguinal hernia
Description
Prevalence of patients found to have an occult inguinal hernia during their initial inguinal surgery
Time Frame
Time of surgery
Title
Groin pain on occult hernia side
Description
Pain assessed by a validated visual assessment score
Time Frame
1 month and 1 year post-operative
Title
Time duration for surgery
Description
Assessed by looking at the total time for the surgery to repair the inguinal hernia(s)
Time Frame
Time of surgery
Title
Time off work due to the hernia surgery
Description
The amount of time (days) patients had to take time off from work for the hernia surgery
Time Frame
Baseline to 2 years post-operative
Title
Time to resume normal activity from any hernia surgery
Description
The amount of time (days) it took for patients to resume their normal activities following hernia surgery
Time Frame
Baseline to 2 years post-operative
Title
Satisfaction with Decision Scale
Description
A decision scale looking at risk vs. benefit of hernia surgery will be done with patients
Time Frame
Baseline to 2 years post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Holihan, MD
Phone
713-500-7188
Email
Julie.L.Holihan@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Debbie F Lew, MPH, CCRC
Phone
713-566-5097
Email
Debbie.F.Lew@uth.tmc.edu
Facility Information:
Facility Name
Lyndon B. Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Holihan, MD
Phone
713-500-7188
Email
Julie.L.Holihan@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Debbie F Lew, MPH, CCRC
Phone
713-566-5097
Email
Debbie.F.Lew@uth.tmc.edu
Facility Name
Memorial Hermann Hospital-MIST Clinics
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Holihan, MD
Phone
713-500-7188
Email
Julie.L.Holihan@uth.tmc.edu

12. IPD Sharing Statement

Learn more about this trial

Treatment of Occult Inguinal Hernias

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