Primary Inguinal HerniaNCT03488342
Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia
A study testing Repair for primary inguinal hernia in people with Primary Inguinal Hernia, run by Hospital Siberia-Serena at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 93 years
- Conditions the study is for
- Primary Inguinal Hernia
- What is being tested?
- Repair for primary inguinal hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 93 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Refusal to give informed consent. Refusal to participate giant inguinal hernias
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Siberia Serena
Talarrubias, Badajoz, 06640
Enrique Javier Grau Talens, PhD, +34616182400, ejgtalens@yahoo.es
José Jacob Motos Micó, MD, +34633257986, jacob_motos@hotmail.com
About this study
Official title: Randomized Clinical Trial of Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia
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.
Read the detailed description
These techniques have not been compared randomly for assessment of chronic pain, postoperative complications and recurrences
- Conditions
- Primary Inguinal Hernia
- Being tested
- Repair for primary inguinal hernia
- Keywords
- Rives technique, Lichtenstein repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair for primary inguinal herniaProcedure or surgery
Repair for primary inguinal hernia
| Study group | Role | What they receive |
|---|---|---|
| Rives technique | Other | Rives technique for primary inguinal hernia Receives: Procedure: Repair for primary inguinal hernia |
| Lichtenstein repair | Other | Lichtenstein repair for primary inguinal hernia Receives: Procedure: Repair for primary inguinal hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 days
Secondary outcomes (2)
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)
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study startSep 2015
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomized,controlled and double-blind study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Siberia-Serena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Jacob Motos Micó, Hospital Siberia-Serena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488342
- Sponsor's protocol ID
- HSiberia-Serena
- Status last verified
- Mar 2018
- First submitted
- 22 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia
- ClinicalTrials.gov ID
- NCT03488342
- Acronym / sponsor ID
- HSiberia-Serena
- Conditions
- Primary Inguinal Hernia
- Keywords
- Rives technique, Lichtenstein repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospital Siberia-SerenaUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized,controlled and double-blind study
| Arm | Type | Receives |
|---|---|---|
| Rives technique | Other | Procedure: Repair for primary inguinal herniaRives technique for primary inguinal hernia |
| Lichtenstein repair | Other | Procedure: Repair for primary inguinal herniaLichtenstein repair for primary inguinal hernia |
Who may qualify
- Ages
- 18 to 93 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to give informed consent. Refusal to participate giant inguinal hernias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repair for primary inguinal herniaRepair for primary inguinal hernia | Procedure or surgery | Lichtenstein repair, Rives technique |
Primary outcome
Evaluate postoperative complications of pain
Time frame: 7 days
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)
2 secondary outcomes
Evaluate the chronic pain
Time frame: 1 year
Evaluate the recurrences
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair for primary inguinal hernia in people with Primary Inguinal Hernia, run by Hospital Siberia-Serena at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrique Javier Grau Talens, PhD (+34616182400, ejgtalens@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate postoperative complications of pain (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.