Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

Primary Inguinal Hernia Clinical Trial

Official title:

Randomized Clinical Trial of Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03488342
• Other study ID #: HSiberia-Serena
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2018
• Last updated: March 28, 2018
• Start date: September 2015
• Est. completion date: November 2018

Study information

• Verified date: March 2018
• Source: Hospital Siberia-Serena
• Contact: Enrique Javier Grau Talens, PhD
• Phone: +34616182400
• Email: ejgtalens[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

These techniques have not been compared randomly for assessment of chronic pain, postoperative complications and recurrences

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 93 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Primary Inguinal Hernia

Intervention

Procedure:
• Repair for primary inguinal hernia
Repair for primary inguinal hernia

Locations

Country	Name	City	State
Spain	Hospital Siberia Serena	Talarrubias	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Siberia-Serena

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	7 days
Secondary	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)	1 year
Secondary	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.	1 year