Inguinal HerniaNCT01348477
Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique in Inguinal Hernia
A study testing Elliptical domed mesh technique in people with Inguinal Hernia, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
The investigators describe a new surgical technique for inguinal hernia open repair, which will be compared with the Lichtenstein technique. The investigators seek to find the difference between the two techniques in postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Elliptical domed mesh technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2010to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients diagnosed with uncomplicated primary inguinal hernia
- mentally healthy patients
- patients without preoperative groin pain
- patients eligible for outpatient surgery
Who cannot join
- patients with different surgical diagnosis
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Ambulatory care medical unit number 55 (UMAA 55)
León, Guanajuato
Rafal L Smolinski, surgeon, 52-477-7768584, ludwiksrk@hotmail.com
Sergio E Solorio, researcher, 52-477-7174800, soloriosergio@aol.com
About this study
Official title: Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique, to Reduce Postoperative Pain in Open Inguinal Hernia Repair
The investigators describe a new surgical technique for inguinal hernia open repair, which will be compared with the Lichtenstein technique. The investigators seek to find the difference between the two techniques in postoperative pain.
Read the detailed description
The investigators randomly assigned 168 adult patients with uncomplicated primary inguinal hernia to two treatment groups:
Group A: 84 patients treated with the new technique Group B: 84 patients treated with the technique of Lichtenstein (gold standard) The investigators reviewed the patients operated on one week, one month, three months and six months after surgery. The investigators evaluated the presence of moderate to severe pain in each technique, as well as the intensity of pain, measured by visual analogue scale.
The investigators also determined the presence of inguinal dysesthesias in each technique, measured by dermatome mapping.
- Conditions
- Inguinal Hernia
- Being tested
- Elliptical domed mesh technique
- Keywords
- inguinal, hernia, pain, inguinodynia, mesh
- Medical subject headings
- Hernia, Inguinal, Hernia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elliptical domed mesh techniqueProcedure or surgery
Also called preperitoneal mesh
A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches
| Study group | Role | What they receive |
|---|---|---|
| Elliptical domed mesh technique | Experimental | 84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique Receives: Procedure: Elliptical domed mesh technique |
| Lichtenstein technique | Active comparator | 84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard) Receives: Procedure: Elliptical domed mesh technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain one month after surgery
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
Measured: one month
pain three months after surgery
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
Measured: three months
pain six months after surgery
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
Measured: six months
Secondary outcomes (3)
dysesthesia one month after surgery
Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible.
Measured: one month
dysesthesia three months after surgery
Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible.
Measured: three months
dysesthesia six months after surgery
Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Investigators
- Rafal L Smolinski, surgeon, Principal investigator, IMSSMartha A Hernandez, researcher, Study director, IMSSSergio E Solorio, researcher, Study chair, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348477
- Sponsor's protocol ID
- R-2010-1005-10
- Status last verified
- Sep 2010
- First submitted
- 2 May 2011
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique, to Reduce Postoperative Pain in Open Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT01348477
- Acronym / sponsor ID
- R-2010-1005-10
- Conditions
- Inguinal Hernia
- Keywords
- inguinal, hernia, pain, inguinodynia, mesh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 5 May 2011 (estimated)
- 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.
The investigators describe a new surgical technique for inguinal hernia open repair, which will be compared with the Lichtenstein technique. The investigators seek to find the difference between the two techniques in postoperative pain.
Detailed description
The investigators randomly assigned 168 adult patients with uncomplicated primary inguinal hernia to two treatment groups:
Group A: 84 patients treated with the new technique Group B: 84 patients treated with the technique of Lichtenstein (gold standard) The investigators reviewed the patients operated on one week, one month, three months and six months after surgery. The investigators evaluated the presence of moderate to severe pain in each technique, as well as the intensity of pain, measured by visual analogue scale.
The investigators also determined the presence of inguinal dysesthesias in each technique, measured by dermatome mapping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elliptical domed mesh technique | Experimental | Procedure: Elliptical domed mesh technique84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique |
| Lichtenstein technique | Active comparator | Procedure: Elliptical domed mesh technique84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients diagnosed with uncomplicated primary inguinal hernia
- mentally healthy patients
- patients without preoperative groin pain
- patients eligible for outpatient surgery
Key exclusion criteria (1 listed)
- patients with different surgical diagnosis
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 |
|---|---|---|
| Elliptical domed mesh techniqueAlso: preperitoneal meshA segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches | Procedure or surgery | Elliptical domed mesh technique, Lichtenstein technique |
Primary outcome
pain one month after surgery
Time frame: one month
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
pain three months after surgery
Time frame: three months
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
pain six months after surgery
Time frame: six months
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
3 secondary outcomes
dysesthesia one month after surgery
Time frame: one month
dysesthesia three months after surgery
Time frame: three months
dysesthesia six months after surgery
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
Related trials for Inguinal Hernia
Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
Not yet recruiting
Bassini Repair Versus Desarda Technique in Urgent Complicated Inguinal Hernia Repair
Inguinal Hernia, Incarcerated Inguinal Hernia
Active, not recruiting
Evaluating the Efficacy and Safety of a New Laparoscopic Non-mesh Hernia Needle Set Designed for Indirect Inguinal Hernia
Inguinal Hernia, Without Mention of Obstruction or Gangrene
Recruiting
Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair
Inguinal Hernia Unilateral, Complications of Surgical Procedures or Medical Care
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
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.
Rafal L Smolinski, surgeon principal investigator
IMSS
Martha A Hernandez, researcher study director
IMSS
Sergio E Solorio, researcher study chair
IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elliptical domed mesh technique in people with Inguinal Hernia, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 4 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 May 2011. 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 Mexico. 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 Rafal L Smolinski, surgeon (52-477-7768584, ludwiksrk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain one month after surgery (time frame: one month). The study lists 3 primary outcomes in all. 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 May 2011; AzTrials last refreshed its copy on 4 Nov 2026.