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Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

Primary Purpose

Primary Inguinal Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Repair for primary inguinal hernia
Sponsored by
Hospital Siberia-Serena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Inguinal Hernia focused on measuring Rives technique, Lichtenstein repair

Eligibility Criteria

18 Years - 93 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men or women aged between 18 and 93 years (inclusive) at the time of the first screening visit.

They must provide signed written informed consent and agree to comply the study protocol

Exclusion Criteria:

Refusal to give informed consent. Refusal to participate giant inguinal hernias

Sites / Locations

  • Hospital Siberia SerenaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Rives technique

Lichtenstein repair

Arm Description

Rives technique for primary inguinal hernia

Lichtenstein repair for primary inguinal hernia

Outcomes

Primary Outcome Measures

Evaluate postoperative complications of pain
The patients are clinically reviewed in the office within 7 days of discharge (pain is evaluated at rest and with movement (standing up, sitting down, and walking), using a VAS (visual analogue scale). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

Secondary Outcome Measures

Evaluate the chronic pain
The patients are reviewed clinically by the service's surgeons again after a year. If pain is found, this is evaluated as being with movement, spontaneous, episodic, or constant in nature, and measured with a VAS. The patients are clinically reviewed in the office: pain is evaluated at rest and with movement (standing up, sitting down, and walking), using a VAS (visual analogue scale). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Evaluate the recurrences
The patients are reviewed clinically by the service's surgeons again after a year. The inguinal region is examined. A mass, reducible or otherwise, is regarded as a recurrence.

Full Information

First Posted
March 22, 2018
Last Updated
March 28, 2018
Sponsor
Hospital Siberia-Serena
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1. Study Identification

Unique Protocol Identification Number
NCT03488342
Brief Title
Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia
Official Title
Randomized Clinical Trial of Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Siberia-Serena

4. Oversight

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

5. Study Description

Brief Summary
Lichtenstein technique, inserting a mesh over the inguinal cord in the neurological plane, is considered the standard of inguinal hernia repair, but it has 4% recurrence and 12% chronic postoperative pain. Rives technique inserts the mesh in the preperitoneal space behind the neurological plane and the muscular plane, thus better fulfilling the principle of hydrostatics.
Detailed Description
These techniques have not been compared randomly for assessment of chronic pain, postoperative complications and recurrences

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Inguinal Hernia
Keywords
Rives technique, Lichtenstein repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
randomized,controlled and double-blind study
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rives technique
Arm Type
Other
Arm Description
Rives technique for primary inguinal hernia
Arm Title
Lichtenstein repair
Arm Type
Other
Arm Description
Lichtenstein repair for primary inguinal hernia
Intervention Type
Procedure
Intervention Name(s)
Repair for primary inguinal hernia
Intervention Description
Repair for primary inguinal hernia
Primary Outcome Measure Information:
Title
Evaluate postoperative complications of pain
Description
The patients are clinically reviewed in the office within 7 days of discharge (pain is evaluated at rest and with movement (standing up, sitting down, and walking), using a VAS (visual analogue scale). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Evaluate the chronic pain
Description
The patients are reviewed clinically by the service's surgeons again after a year. If pain is found, this is evaluated as being with movement, spontaneous, episodic, or constant in nature, and measured with a VAS. The patients are clinically reviewed in the office: pain is evaluated at rest and with movement (standing up, sitting down, and walking), using a VAS (visual analogue scale). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Time Frame
1 year
Title
Evaluate the recurrences
Description
The patients are reviewed clinically by the service's surgeons again after a year. The inguinal region is examined. A mass, reducible or otherwise, is regarded as a recurrence.
Time Frame
1 year

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
93 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women aged between 18 and 93 years (inclusive) at the time of the first screening visit. They must provide signed written informed consent and agree to comply the study protocol Exclusion Criteria: Refusal to give informed consent. Refusal to participate giant inguinal hernias
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrique Javier Grau Talens, PhD
Phone
+34616182400
Email
ejgtalens@yahoo.es
First Name & Middle Initial & Last Name or Official Title & Degree
José Jacob Motos Micó, MD
Phone
+34633257986
Email
jacob_motos@hotmail.com
Facility Information:
Facility Name
Hospital Siberia Serena
City
Talarrubias
State/Province
Badajoz
ZIP/Postal Code
06640
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Javier Grau Talens, PhD
Phone
+34616182400
Email
ejgtalens@yahoo.es
First Name & Middle Initial & Last Name & Degree
José Jacob Motos Micó, MD
Phone
+34633257986
Email
jacob_motos@hotmail.com
First Name & Middle Initial & Last Name & Degree
Enrique Javier Grau Talens, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

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