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NCT05484635 · ClinicalTrials.gov registry record · NA
Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair
A NA study of Hernia, Inguinal and Chronic Groin Pain, sponsored by David Krpata.
- Recruiting
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT05484635: Recruiting NA study of Hernia, Inguinal and Chronic Groin Pain, sponsored by David Krpata.
NCT05484635 is a NA study of Hernia, Inguinal and Chronic Groin Pain that is actively recruiting participants, run by David Krpata. The registered enrollment target is 70 participants, below the 101-participant average among 4 other Hernia, Inguinal trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05484635, a NA study of Hernia, Inguinal and Chronic Groin Pain, is actively recruiting participants, sponsored by David Krpata.
- RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is evaluating the management of chronic post-operative inguinal hernia pain and the impact of hernia mesh removal after previous minimally invasive inguinal hernia repairs. The study aims are to evaluate the change in chronic (\>6 months), nociceptive, postoperative inguinal pain after mesh removal compared to no mesh removal in patients who have previously undergone minimally invasive inguinal hernia repair with pre-peritoneal mesh.
Primary Outcome
NRS-11 is a validated, 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) and is commonly used to measure Chronic Post-operative Inguinal Pain (CPIP). NRS-11 categorizes pain as none \[0\], mild \[1-3\], moderate \[4-6\], and severe \[7-10\]. Patients will be asked to select the single number that best represents their groin pain intensity when moving from a supine to standing position.
Conditions Studied
Interventions
- PROCEDURE Diagnostic laparoscopy and inguinal mesh removal
- PROCEDURE Diagnostic laparoscopy
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2022-07-25 |
| Est. Completion | 2028-07-01 |
| Phase | NA |
What NCT05484635 shows while recruiting
NCT05484635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 101-participant average among 4 other Hernia, Inguinal trials with a reported enrollment target (31% lower).
The record links to 2 conditions, with Hernia, Inguinal appearing as the primary indexed condition, and to 2 interventions - of which Diagnostic laparoscopy and inguinal mesh removal is the first listed.
NCT05484635 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05484635 about?
NCT05484635 is a clinical study titled "Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair". This study is evaluating the management of chronic post-operative inguinal hernia pain and the impact of hernia mesh removal after previous minimally invasive inguinal hernia repairs. The study aims are to evaluate the change in chronic (\>6 months), nociceptive, postoperative inguinal pain after m...
What is the current status of trial NCT05484635?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2022-07-25. Estimated completion is 2028-07-01.
What conditions does trial NCT05484635 study?
This clinical trial studies the following conditions: Hernia, Inguinal, Chronic Groin Pain.
What interventions are being tested in trial NCT05484635?
The interventions under investigation include: Diagnostic laparoscopy and inguinal mesh removal (PROCEDURE), Diagnostic laparoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT05484635?
This trial is sponsored by David Krpata, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05484635 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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