Inguinal Hernia Clinical Trial
Official title:
A Prospective, Randomized, Double-armed, Single-blinded, Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs. Lichtenstein inguinal hernia repair.
The primary objectives of this study will be to evaluate the immediate and short-term amount
of post-operative pain, the quality of life (QOL), as well as return to normal activities
(work) for the two procedures. Carolinas Comfort Scale (CCS) and Visual Analogue Score (VAS)
assessments will be held at regular intervals to evaluate these objectives.
The secondary objective of the study is to identify any short-term study related
complications/adverse events.
The follow up will be immediately post-operative, post-operative day 1, and 1, 2,and 4
weeks. The first and 4th week's visits are mandatory office visits (if possible). If not
available for office visit, a CCS assessment will be mailed or will be conducted via phone.
Up to 50 patients may be enrolled for this study (25 per arm). A report may be generated for
presentation at an international meeting such as the AHS, EHS, or APHS if decided by the
lead investigator.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03023462 -
Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
|
N/A | |
| Completed |
NCT04272320 -
The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair
|
N/A | |
| Recruiting |
NCT03904888 -
Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair
|
N/A | |
| Recruiting |
NCT03856710 -
Self Fixating Versus Stapled Mesh for Laparoscopic Inguinal Hernia Repair
|
N/A | |
| Completed |
NCT01679353 -
Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair
|
N/A | |
| Completed |
NCT01943760 -
Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty
|
Phase 4 | |
| Recruiting |
NCT01450345 -
Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
|
Phase 3 | |
| Active, not recruiting |
NCT00968773 -
Rebound Hernia Repair Device Mesh Trial
|
Phase 4 | |
| Completed |
NCT01000116 -
Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)
|
N/A | |
| Completed |
NCT01117337 -
Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair
|
Phase 4 | |
| Terminated |
NCT00226161 -
Chronic Pain After Inguinal Herniorrhaphy
|
N/A | |
| Completed |
NCT05837013 -
Open and Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia
|
N/A | |
| Recruiting |
NCT05058378 -
Correlation Between Spinal Anesthesia and Perfusion Index
|
||
| Completed |
NCT01637818 -
Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair
|
N/A | |
| Recruiting |
NCT05879770 -
Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
|
||
| Completed |
NCT05159232 -
Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial
|
N/A | |
| Completed |
NCT05107986 -
Laparoscopy in Complicated Groin Hernia
|
||
| Active, not recruiting |
NCT04328597 -
Portuguese Inguinal Hernia Cohort (PINE) Study
|
||
| Completed |
NCT04033055 -
Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia.
|
N/A | |
| Completed |
NCT03590145 -
Reliability of the Doha Agreement Classification of Groin Pain
|