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Dynamic Scaffold Versus Lichtenstein Open Hernioplasty. (DYSLOH)

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
inguinal hernia repair with mesh
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring inguinal hernia repair, ProFlor technique, lichtenstein hernia repair

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Eligible patients were individuals aged between 18 and 85 years old, competent to give consent, affected by clinically relevant primary inguinal hernia scheduled to undergo elective inguinal hernia repair and eligible for outpatient surgical procedure with local anesthesia. Exclusion Criteria: Recurrent inguinal hernia Incarcerated inguinal hernia Hernia not in the inguinal area Signs of obvious local or systemic infection ASA score > 4 Presenting with unstable angina or NYHA class of IV Pregnant Active drug user Immunosuppression, chemotherapy Chronic renal insufficiency Abdominal ascites Infection in area of the surgical field BMI >35

Sites / Locations

  • University of Palermo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ProFlor

Lichtenstein

Arm Description

patients underwent to inguinal hernia repair with use of ProFlor dynamic scaffold

patients underwent to Lichtenstein inguinal hernia repair

Outcomes

Primary Outcome Measures

early postoperative complications
bleeding, hematoma and infections
patients clinical outcome
VAS score

Secondary Outcome Measures

evaluation of quality of life during the postoperative period
Carolina Comfort Scale - CCS

Full Information

First Posted
January 21, 2023
Last Updated
January 21, 2023
Sponsor
University of Palermo
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1. Study Identification

Unique Protocol Identification Number
NCT05706662
Brief Title
Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.
Acronym
DYSLOH
Official Title
The DySLOH Study: Dynamic Scaffold Versus Lichtenstein Open Hernioplasty. A Comparative Outcome Assessment Between the Two Techniques.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo

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
Evaluating the outcomes of patients undergoing open anterior inguinal hernioplasty comparing two different techniques: Lichtenstein/plug and mesh and ProFlor. The outcomes of these two groups of patients, respectively the Lichtenstein inguinal hernia repair with static flat mesh and the defect obliteration with 3D dynamic scaffold Proflor, are compared in respect to defined variables along stages: intraoperative, early and long term postoperative.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
inguinal hernia repair, ProFlor technique, lichtenstein hernia repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ProFlor
Arm Type
Experimental
Arm Description
patients underwent to inguinal hernia repair with use of ProFlor dynamic scaffold
Arm Title
Lichtenstein
Arm Type
Active Comparator
Arm Description
patients underwent to Lichtenstein inguinal hernia repair
Intervention Type
Procedure
Intervention Name(s)
inguinal hernia repair with mesh
Intervention Description
inguinal hernia repair with mesh
Primary Outcome Measure Information:
Title
early postoperative complications
Description
bleeding, hematoma and infections
Time Frame
30 days after surgery
Title
patients clinical outcome
Description
VAS score
Time Frame
24 months
Secondary Outcome Measure Information:
Title
evaluation of quality of life during the postoperative period
Description
Carolina Comfort Scale - CCS
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible patients were individuals aged between 18 and 85 years old, competent to give consent, affected by clinically relevant primary inguinal hernia scheduled to undergo elective inguinal hernia repair and eligible for outpatient surgical procedure with local anesthesia. Exclusion Criteria: Recurrent inguinal hernia Incarcerated inguinal hernia Hernia not in the inguinal area Signs of obvious local or systemic infection ASA score > 4 Presenting with unstable angina or NYHA class of IV Pregnant Active drug user Immunosuppression, chemotherapy Chronic renal insufficiency Abdominal ascites Infection in area of the surgical field BMI >35
Facility Information:
Facility Name
University of Palermo
City
Palermo
ZIP/Postal Code
90127
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.

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