Inguinal HerniaNCT03842852
Laparoscopic TEP (Total Extra-peritoneal) Repair Vs Open PHS (Prolene Hernia System)
An observational study of Inguinal Hernia, run by Assuta Medical Center at 1 site in Israel.
Trial summary
Abdominal wall hernias are common, with a lifetime risk of 27% in men and 3% in women. Inguinal and femoral hernias are the most common affections faced by primary care physicians that require surgical intervention. The most common hernia in both sexes is the indirect inguinal hernia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Inguinal hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 577 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2003to 31 Dec 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that underwent laparoscopic (TEP) repair with bilateral or recurrent hernia or open PHS repair with unilateral hernia or contraindication for general anesthesia .
Who may be able to join
- For laparoscopic repair: bilateral inguinal hernia or recurrent hernia For open repair: Patients with unilateral inguinal hernia More than 18 years old. Both sexes
Who cannot join
- Patient under 18 years old Patients who cannot sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparition of the Results of Inguinal Hernia Repair Using Laparoscopic Total Extra-peritoneal or Open Prolene Hernia System Approach
Abdominal wall hernias are common, with a lifetime risk of 27% in men and 3% in women.
Inguinal and femoral hernias are the most common affections faced by primary care physicians that require surgical intervention.
Read more
The most common hernia in both sexes is the indirect inguinal hernia. The male-to-female ratio is 9:1 for inguinal hernias and 1:3 for femoral hernias. Inguinal hernia repair is one of the most common operations undertaken in routine surgical practice.
Since the introduction of the Bassini method in 1887, more than 70 types of pure tissue repair have been reported in the surgical literature. Throughout the years, attention was paid to the recurrences that occur after the use of tissue approximation technique, in the literature it has been reported that they occur in up to 34% of cases, being that the actual incidence of recurrences it is underreported, therefore, the repair of the hernia with approximation of tissue has practically been abandoned.
The concept of tension free repair for hernias was introduced by Lichtenstein who explain that the prime etiologic factor behind most herniorrhaphy failures is the suturing together, under tension, of structures that are not normally in apposition. The technique of the hernioplasty with the use of mesh was not widely accepted at first, the expansion of the use of mesh expanded for years. The use of mesh increased from 7 per cent of all operations in 1992 to 51 per cent in 1996. Currently, groin hernia treatment is not standardized but, today, tension free mesh repair technique is regarded as gold standard. Based in the Stoppa technique, the laparoscopic hernia repair was developed in 1991. The most common laparoscopic techniques for inguinal hernia repair are transabdominal preperitoneal (TAPP) repair and total extraperitoneal (TEP) repair. The use of the laparoscopic technique was progressively increasing based on the advantages of minimal invasive procedures, but since the publication of Neumayer in 2004, where he reports a recurrent incidence in laparoscopic hernia of 10.1 % compared with 4% for open surgery, the use of laparoscopic repair declines considerably. Surgeons remain divided on the best technique for inguinal hernia repair: while more than half never perform laparoscopic inguinal hernia repair, today the laparoscopic technique for hernia repair is used in 28% of cases, of which 25% is used the TEP approach and is considered the best approach for bilateral inguinal hernia repair (17). Advantages and disadvantages of TEP are: faster return to usual activities, operation times are longer and there appears to be a higher risk of serious complication rate in respect of visceral (especially bladder) and vascular injuries (18).
In 1999, Gilbert published the use of bilayer patch device, known as prolene ® hernia system (Ethicon; Somerville, NJ, USA) (PHS) to repair inguinal hernia. The unique feature of this polypropylene mesh device is that it has attached the component, its underlay patch provides a pre-peritoneal repair, a connector that has the desirable attributes of a plug and an onlay patch covers the back wall. In the literature, better results have been reported for PHS repair than for Lichtenstein repair. The advantages of the anterior repair of inguinal hernias are: low operative costs, short learning curve, reproducible results at all levels and the possibility of the use of local anesthesia.
The objective of this study is to compare the results of laparoscopic totally extra-peritoneal repair (LTEPR) with open prolene hernia system repair (OPHSR) retrospectively.
Read the detailed description
In our environment, 10367 (10.41% of all surgeries) hernia repair are performed in one year, of witch 5797 (51.92%) are inguinal hernia repair, of them 2870 (49.51%) are performed laparoscopically and 2927 (50.49%) are performed using different open repair techniques.
All consecutive patients that underwent LTEPR repair of inguinal hernia from 2003 to 2007 and open OPHSR inguinal hernia repair from 2008 to 2015, were analyzed. A total of 577 patients were included divided in two groups, the LTEPR group 293 patients and in the OPHSR group 284 patient. The selection of patients for LTEPR was bilateral inguinal hernia or recurrence after open repair, for OPHSR was unilateral inguinal hernia or health condition with preference to regional or local anesthesia. The follow up of all patients was between 18 to 60 months (mean 38.10 month).
Setting The LTEPR group was operated by two surgeons with long experience in laparoscopic hernia repair in a public hospital. The selected patients were those with bilateral inguinal hernia or recurrent hernia after open surgery, patients with contraindication for general anesthesia and patients with low midline scar or Pfannenstiel incision were excluded. Patients of the OPHSR group were operated in a private hospital by medical specialists in surgery with experience in repair using PHS; patients under local anesthesia were excluded.
Operative technique Pre-op antibiotic shot of 2rd generation cephalosporin was given to all the patients.
For LTEPR, under general anesthesia and supine position the plane preperitoneal was developed using a kidney-balloon trocar (Covidien-Medtronic, New Haven, CT, USA) using the 45 degrees scope to evaluate the plane. After developing the preperitoneal space, a structural trocar (Covidien-Medtronic, New Haven, CT, USA) was inserted and the space inflated with gas with low pressure. One working 10-millimeter trocar was inserted in the midline high as possible, if was necessary one more 5-millimeter trocar was inserted under the first one.
An atraumatic dissection of the groin was performed, the regional vessels (Corona Mortis, femoral and epigastric) were recognized, the cord was dissected and the peritoneal edge separated and retracted proximally wherever possible. A broad dissection was performed laterally including the Bogros space and superiorly releasing the peritoneum from the anterior abdominal wall.
To repair the groin, we use a heavyweight poli-propilene mesh 15X15 centimeters, divides in a piece of 15X5 centimeter inserted under the cord and fixed with helical tackers (Covidien-Medtronic, New Haven, CT, USA) to the ramus pubis and laterally to the transverse abdominal muscle. The second piece of mesh, 10X15 centimeter above the cord overlapping the anterior piece and fixing it to the rectus abdomini and to first mesh inserted. The gas was released and Bupivacaine Hydrochloride 0.5% was injected trough the trocar in the preperitoneal space.
For OPHSR, under regional or general anesthesia, in supine position, the groin was incised transversally, the planes were developed and after reduce de sac, the entry to the pre-peritoneal space was gained through the internal ring in indirect hernias, or medial defect in direct hernias. The preperitoneal space was the developed widely in atraumatic way. The posterior patch of the PHS was introduced pre-peritoneally and the onlay patch was fixed with continuous polypropylene sutures or separate stitches. Bupivacaine hydrochloride 0.5% was injected into the tissue around the repair.
This study was approved by the institution's ethics committee (Helsinki board). Statistical analysis All of the measured variables and derived parameters were tabulated using descriptive statistics. For the categorical variables, the summary tables provided the sample size, and absolute and relative frequencies. For the continuous variables, the summary tables provided the sample size, arithmetic mean, standard deviation, median, minimum and maximum values, and 95% confidence intervals (CI) for the means of the variables.
Analyses were performed using SPSS for Windows version 22.0 (SPSS, Chicago, IL, USA). Differences between two groups were analyzed using the Chi-square test, Fisher's exact test and t-test as adequate. Results were considered statistically significant at p < 0.05.
- Conditions
- Inguinal Hernia
- Being tested
- Inguinal hernia repair
- Keywords
- inguinal hernia, laparoscopy reapir, open repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal hernia repairProcedure or surgery
The grupo one underwent open repair and laparoscopic repair
| Study group | Role | What they receive |
|---|---|---|
| LTEPR | Patients who underwent inguinal hernia repair laparoscopic extra-peritoneal repair under general anesthesia. Receives: Procedure: Inguinal hernia repair | |
| OPHSR | Patients that underwent inguinal hernia repair open using prolene hernia system mesh under general or regional anesthesia. Receives: Procedure: Inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale
the patients were asked to classified their pair after surgery in visual analog scale from 0 to 10, being 0: no pain and 10 severe pain. (0: no pain, 1 to 3: mild pain, 4 to 6: moderate pain, and 7 to 10 severe pain.
Measured: 60 months
complication after surgery
Complications were recorded from the records: type and number. Each type of complication is presented in a number of occurrences and calculates the percent of occurrence.
Measured: 60 months
Secondary outcomes (3)
Diary activity performance
patients were asked to respond about diary activity performing: no changes when the patient continues with the same job and sports activities improved: when the patient can do their normal activities without symptoms or sports activities, and worse: when the patients can not do their normal activities at all and are symptomatic.
Measured: 60 months
Scar satisfaction
very satisfied- satisfied and unsatisfied depending in a subjective appreciation of the patients
Measured: 60 months
sexual function
Better than before surgery, no changes or worse depending in can do their normal sexual function without symptoms, better or worse than before.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jan 2003
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
- Investigators
- sergio Susmallian, MD, Principal investigator, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842852
- Sponsor's protocol ID
- 02-19
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected includes: names, type of surgery' complication, pain assessment, readmissions, satisfaction with the results, preoperative ASA clasification , postoperative hernia classification.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparition of the Results of Inguinal Hernia Repair Using Laparoscopic Total Extra-peritoneal or Open Prolene Hernia System Approach
- ClinicalTrials.gov ID
- NCT03842852
- Acronym / sponsor ID
- 02-19
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, laparoscopy reapir, open repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 15 Feb 2019 (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.
Abdominal wall hernias are common, with a lifetime risk of 27% in men and 3% in women.
Inguinal and femoral hernias are the most common affections faced by primary care physicians that require surgical intervention.
The most common hernia in both sexes is the indirect inguinal hernia. The male-to-female ratio is 9:1 for inguinal hernias and 1:3 for femoral hernias. Inguinal hernia repair is one of the most common operations undertaken in routine surgical practice.
Since the introduction of the Bassini method in 1887, more than 70 types of pure tissue repair have been reported in the surgical literature. Throughout the years, attention was paid to the recurrences that occur after the use of tissue approximation technique, in the literature it has been reported that they occur in up to 34% of cases, being that the actual incidence of recurrences it is underreported, therefore, the repair of the hernia with approximation of tissue has practically been abandoned.
The concept of tension free repair for hernias was introduced by Lichtenstein who explain that the prime etiologic factor behind most herniorrhaphy failures is the suturing together, under tension, of structures that are not normally in apposition. The technique of the hernioplasty with the use of mesh was not widely accepted at first, the expansion of the use of mesh expanded for years. The use of mesh increased from 7 per cent of all operations in 1992 to 51 per cent in 1996. Currently, groin hernia treatment is not standardized but, today, tension free mesh repair technique is regarded as gold standard. Based in the Stoppa technique, the laparoscopic hernia repair was developed in 1991. The most common laparoscopic techniques for inguinal hernia repair are transabdominal preperitoneal (TAPP) repair and total extraperitoneal (TEP) repair. The use of the laparoscopic technique was progressively increasing based on the advantages of minimal invasive procedures, but since the publication of Neumayer in 2004, where he reports a recurrent incidence in laparoscopic hernia of 10.1 % compared with 4% for open surgery, the use of laparoscopic repair declines considerably. Surgeons remain divided on the best technique for inguinal hernia repair: while more than half never perform laparoscopic inguinal hernia repair, today the laparoscopic technique for hernia repair is used in 28% of cases, of which 25% is used the TEP approach and is considered the best approach for bilateral inguinal hernia repair (17). Advantages and disadvantages of TEP are: faster return to usual activities, operation times are longer and there appears to be a higher risk of serious complication rate in respect of visceral (especially bladder) and vascular injuries (18).
In 1999, Gilbert published the use of bilayer patch device, known as prolene ® hernia system (Ethicon; Somerville, NJ, USA) (PHS) to repair inguinal hernia. The unique feature of this polypropylene mesh device is that it has attached the component, its underlay patch provides a pre-peritoneal repair, a connector that has the desirable attributes of a plug and an onlay patch covers the back wall. In the literature, better results have been reported for PHS repair than for Lichtenstein repair. The advantages of the anterior repair of inguinal hernias are: low operative costs, short learning curve, reproducible results at all levels and the possibility of the use of local anesthesia.
The objective of this study is to compare the results of laparoscopic totally extra-peritoneal repair (LTEPR) with open prolene hernia system repair (OPHSR) retrospectively.
Detailed description
In our environment, 10367 (10.41% of all surgeries) hernia repair are performed in one year, of witch 5797 (51.92%) are inguinal hernia repair, of them 2870 (49.51%) are performed laparoscopically and 2927 (50.49%) are performed using different open repair techniques.
All consecutive patients that underwent LTEPR repair of inguinal hernia from 2003 to 2007 and open OPHSR inguinal hernia repair from 2008 to 2015, were analyzed. A total of 577 patients were included divided in two groups, the LTEPR group 293 patients and in the OPHSR group 284 patient. The selection of patients for LTEPR was bilateral inguinal hernia or recurrence after open repair, for OPHSR was unilateral inguinal hernia or health condition with preference to regional or local anesthesia. The follow up of all patients was between 18 to 60 months (mean 38.10 month).
Setting The LTEPR group was operated by two surgeons with long experience in laparoscopic hernia repair in a public hospital. The selected patients were those with bilateral inguinal hernia or recurrent hernia after open surgery, patients with contraindication for general anesthesia and patients with low midline scar or Pfannenstiel incision were excluded. Patients of the OPHSR group were operated in a private hospital by medical specialists in surgery with experience in repair using PHS; patients under local anesthesia were excluded.
Operative technique Pre-op antibiotic shot of 2rd generation cephalosporin was given to all the patients.
For LTEPR, under general anesthesia and supine position the plane preperitoneal was developed using a kidney-balloon trocar (Covidien-Medtronic, New Haven, CT, USA) using the 45 degrees scope to evaluate the plane. After developing the preperitoneal space, a structural trocar (Covidien-Medtronic, New Haven, CT, USA) was inserted and the space inflated with gas with low pressure. One working 10-millimeter trocar was inserted in the midline high as possible, if was necessary one more 5-millimeter trocar was inserted under the first one.
An atraumatic dissection of the groin was performed, the regional vessels (Corona Mortis, femoral and epigastric) were recognized, the cord was dissected and the peritoneal edge separated and retracted proximally wherever possible. A broad dissection was performed laterally including the Bogros space and superiorly releasing the peritoneum from the anterior abdominal wall.
To repair the groin, we use a heavyweight poli-propilene mesh 15X15 centimeters, divides in a piece of 15X5 centimeter inserted under the cord and fixed with helical tackers (Covidien-Medtronic, New Haven, CT, USA) to the ramus pubis and laterally to the transverse abdominal muscle. The second piece of mesh, 10X15 centimeter above the cord overlapping the anterior piece and fixing it to the rectus abdomini and to first mesh inserted. The gas was released and Bupivacaine Hydrochloride 0.5% was injected trough the trocar in the preperitoneal space.
For OPHSR, under regional or general anesthesia, in supine position, the groin was incised transversally, the planes were developed and after reduce de sac, the entry to the pre-peritoneal space was gained through the internal ring in indirect hernias, or medial defect in direct hernias. The preperitoneal space was the developed widely in atraumatic way. The posterior patch of the PHS was introduced pre-peritoneally and the onlay patch was fixed with continuous polypropylene sutures or separate stitches. Bupivacaine hydrochloride 0.5% was injected into the tissue around the repair.
This study was approved by the institution's ethics committee (Helsinki board). Statistical analysis All of the measured variables and derived parameters were tabulated using descriptive statistics. For the categorical variables, the summary tables provided the sample size, and absolute and relative frequencies. For the continuous variables, the summary tables provided the sample size, arithmetic mean, standard deviation, median, minimum and maximum values, and 95% confidence intervals (CI) for the means of the variables.
Analyses were performed using SPSS for Windows version 22.0 (SPSS, Chicago, IL, USA). Differences between two groups were analyzed using the Chi-square test, Fisher's exact test and t-test as adequate. Results were considered statistically significant at p < 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTEPR | – | Procedure: Inguinal hernia repairPatients who underwent inguinal hernia repair laparoscopic extra-peritoneal repair under general anesthesia. |
| OPHSR | – | Procedure: Inguinal hernia repairPatients that underwent inguinal hernia repair open using prolene hernia system mesh under general or regional anesthesia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that underwent laparoscopic (TEP) repair with bilateral or recurrent hernia or open PHS repair with unilateral hernia or contraindication for general anesthesia .
Key inclusion criteria (1 listed)
- For laparoscopic repair: bilateral inguinal hernia or recurrent hernia For open repair: Patients with unilateral inguinal hernia More than 18 years old. Both sexes
Key exclusion criteria (1 listed)
- Patient under 18 years old Patients who cannot sign the informed consent.
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 |
|---|---|---|
| Inguinal hernia repairThe grupo one underwent open repair and laparoscopic repair | Procedure or surgery | LTEPR, OPHSR |
Primary outcome
Pain scale
Time frame: 60 months
the patients were asked to classified their pair after surgery in visual analog scale from 0 to 10, being 0: no pain and 10 severe pain. (0: no pain, 1 to 3: mild pain, 4 to 6: moderate pain, and 7 to 10 severe pain.
complication after surgery
Time frame: 60 months
Complications were recorded from the records: type and number. Each type of complication is presented in a number of occurrences and calculates the percent of occurrence.
3 secondary outcomes
Diary activity performance
Time frame: 60 months
Scar satisfaction
Time frame: 60 months
sexual function
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: Yes. Data collected includes: names, type of surgery' complication, pain assessment, readmissions, satisfaction with the results, preoperative ASA clasification , postoperative hernia classification.
Related trials for 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
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Active, not recruiting
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Inguinal Hernias
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.
sergio Susmallian, MD principal investigator
Assuta Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Assuta Medical Center at 1 site in Israel.
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 1 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: finished, as of the sponsor's last update on 19 Feb 2019. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale (time frame: 60 months). The study lists 2 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 19 Feb 2019.