Inguinal HerniaNCT04504461
Ambulatory Laparoscopic Inguinal Hernioplasty: Feasibility and Cost Analysis
An observational study of Inguinal Hernia, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Laparoscopic inguinal hernia repair has become one of the elective techniques, attributing the advantages of minimally invasive procedures to it. However, the high costs related to the need for hospitalization and materials make them a limitation at the time of its indication. 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?
- Analysis of feasibility and costs
- How many people
- 116 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Aug 2015to 30 Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 with no major comorbidities that required a laparoscopic inguinal hernioplasty
- Inclusion Criteria:
- Patients older than 18 years old
- Laparoscopic inguinal hernioplasty as the pincipal surgery
- Exclusion Criteria:
- Patients with, high anesthetic risk (decompensated ASA III and ASA IV)
- Morbid obesity (higher BMI 40),
- Sleep apnea with indication of use of CPAP (Continuous Positive Airway Pressure)
- Medicated psychiatric disease,
- Drug-dependent patient
- Patients with an inadequate social environment-
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Ciudad de Buenos Aires, 1199
About this study
Official title: Ambulatory Laparoscopic Inguinal Hernioplasty: Feasibility and Cost Minimization Analysis in a South American Hospital
Laparoscopic inguinal hernia repair has become one of the elective techniques, attributing the advantages of minimally invasive procedures to it. However, the high costs related to the need for hospitalization and materials make them a limitation at the time of its indication.
The objective is to evaluate the feasibility of performing this procedure in an outpatient surgery center and the cost analysis of an outpatient procedure regarding the same in the setting of hospitalization.
Read the detailed description
A retrospective analysis was performed on a prospective database in which all patients older than 18 years were included, in which a laparoscopic inguinal hernioplasty was performed in the period between August 2015 and June 2018 in the unit of ambulatory surgery of the Hospital Italiano de Buenos Aires. The same corresponds to an autonomous unit controlled by a health facility with hospitalization, as established by the Asociación Argentina de Cirugía in the Organization Guide and procedures in Ambulatory Surgery.
Laparoscopic repair using a transabdominal preperitoneal technique (TAPP) was proposed for patients with a clinical diagnosis of bilateral inguinal hernia or a recurrent unilateral hernia operated primarily through the anterior approach following the indications for laparoscopic surgery proposed by the European Hernia Society
The demographic data of the patients considered for this study were: age, gender, body mass index (BMI), anesthetic risk according to ASA (American Society of Anesthesiologists) score, comorbidities, bilateral primary or unilateral recurrent hernia, history of previous abdominal surgeries and associated midline hernias The details of the surgical procedure and the ambulatory surgery regimen, as well as possible postoperative complications, were explained to all patients in the preoperative consultation and an informed consent was signed.
The anesthetic technique was the same for everyone. The patients were operated under general anesthesia. Anesthetic induction was performed with propofol 2 mg / kg EV and fentanyl 2 ug / kg EV. Rocuronium 0.6 mg / kg EV was used to facilitate laryngeal mask placement. The anesthetic level was maintained with air, oxygen, sevoflorane at 1.5% expired and with remifentanil (0.25 at 0.5 ug / kg / min) based on the demand of the patient's plan. It was ventilated mechanically in controlled mode. As intraoperative analgesia, ketorolac 1 mg / kg according to renal function or diclofenac 1 mg / kg was used in patients with a history of bronchospasm. This was associated with 8 mg of dexamethasone. Antibiotic prophylaxis during anesthetic induction was performed with cefazolin 2 gr / kg EV.
In 100% of the cases, the surgical technique used was TAPP. The patient was asked to urinate prior to the transfer to the operating room to avoid the placement of a urinary catheter.
With the patient in the supine position, pneumoperitoneum was performed by umbilical scar with closed Veress needle technique. The abdomen was insufflated with a pressure of 12 mmHg. A 10-mm trocar was placed at the umbilical level and two 5-mm trocars were placed on both flanks outside the rectus sheath. In the event that the patient presents with an associated midline hernia, optic trocar was inserted due to hernia defect. It was approached first on one side and then on the contralateral side. After the opening of the peritoneum, dissection of the preperitoneal space and reduction of the hernial content, a polypropylene mesh (Prolene®, Ethicon Johnson \& Johnson) of 15 x 12 centimeters was placed covering the myopectineal orifice from the symphysis pubis medially, until the anterosuperior iliac spine laterally. In patients with bilateral hernia, two meshes were placed, one on each side respectively, surpassing the midline. The mesh was fixed with tuckers made of resorbable material (Securetrap®) or unabsorbable material (Protack®) according to the preference of the surgeon in charge of the procedure. The peritoneum was closed with continuous suture of slow absorbable material (Vycril®) or slow reabsorbed barb suture (Stratafix®). Local infiltration of all wounds was performed with ropivacaine at a dose of 3 mg / kg.
Surgical time was recorded as intraoperative variables, which was defined as minutes from the preparation of the surgical site to the closure of the skin; the type of hernia according to Nyhus classification and the presence of intraoperative complications.
At the end of the procedure, the patients were transferred to the recovery room. During the postoperative recovery an analgesic scheme was stipulated according to need. The rescues were made according to the evaluation of the nurse and the treating anesthetist and consisted of the following levels:
- First level: ketorolac 30 mg EV or diclofenac 75 mg EV. In patients with decreased glomerular filtration, paracetamol 1000 mg EV was used.
- Second level: morphine 1 - 3 mg EV. When the requirements of the ambulatory surgery guide of the Asociación Argentina de Cirugía listed in table N° 1 were fulfilled, the patient was discharged from hospital. The same was in charge of the responsible surgeon, who delivered the postoperative indications verbally and in writing, confirming the understanding of them by the patient and the companion.
The length of stay in the unit was recorded, as well as the need to administer analgesics during the same and pain according to the visual analog scale (EVA) at discharge.
Feasibility is expressed as the percentage of patients who were referred from the outpatient surgery unit.
The data about postoperative complications were collected prospectively through ambulatory controls previously stipulated at 7, 30, 180 and 360 days. They are classified into early (up to 30 days of the procedure) and late. The first included seroma, surgical site infection and hematoma; and late trocar hernias, recurrence and postoperative pain. Chronic postoperative pain is one that persists beyond the third month after the procedure.
In the first ambulatory control consultation at 7 days, patients were asked to rate their level of satisfaction with the procedure by choosing one of the four categories: not satisfied, not very satisfied, satisfied and very satisfied For the study of costs in addition to outpatients, those patients who underwent laparoscopic inguinal hernia in the inpatient setting during the period analyzed were included in the analysis. In this way, two branches of study were drawn up, one corresponding to patients operated on an outpatient basis and the other to patients operated through a hospital regimen.
Being a surgical procedure performed under a different hospital regime, a cost minimization study was carried out taking the average cost of performing an ambulatory procedure versus the same requiring admission.
When considering the economic situation of the República Argentina in the time under study (devaluation of the peso argentino weight of 100% and inflation of approximately 30% per year), continuous patients operated between December 2016 and April 2017 were taken, which represents the average of the period under study, as representative samples of each branch. For each patient, the surgical time, the persistence time in the ambulatory anesthetic recovery room or the hospitalization room, and the time of postoperative hospitalization were recorded in a database.
The materials used during surgery and anesthesia were previously standardized so that all the patients who underwent this procedure used the same resources.
The cost department of the Hospital Italiano de Buenos Aires was responsible for collecting the costs of each of these patients. They were divided into fixed costs per procedure, per hour/operating room, per hour in the ambulatory surgery recovery room, per hour in the recovery room of the central operating room and per day of hospitalization.
The costs were calculated in Argentine Pesos (AP) and converted into US Dollars (USD) taking into account the exchange rate in January 2017: 1 USD = 16.30 PA.
The categorical data were described as percentages and the quantitative data as mean and standard deviation or median and interquartile range according to the observed distribution. To compare means of quantitative variables, Student's t-test or Mann-Whitney U test was used according to the observed distribution. Chi-square or Fisher's test was used for the rest of the variables. A p <.05 was considered significant.
Regression models were constructed to adjust for confounding potentials.
- Conditions
- Inguinal Hernia
- Being tested
- Analysis of feasibility and costs
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of feasibility and costsOther
Analyze the feasibility and costs of performing laparoscopic inguinal hernioplasty in an ambulatory surgery center
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Inguinal Hernioplasty. Ambulatory | Laparoscopic Inguinal Hernioplasty performed in ambulatory surgery center Receives: Other: Analysis of feasibility and costs | |
| Laparoscopic Inguinal Hernioplasty. Hospital Stay | Laparoscopic Inguinal Hernioplasty that have to stay at least 24 hours at the hospital Receives: Other: Analysis of feasibility and costs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical Complications
Incidence of seroma, Incidence of hematoma, % of reoperation, incidence of wound infection
Measured: Patients follow up is 12 month
Costs of the procedure
Cost of laparoscopic hernioplasty in ambulatory surgery center. Cost of laparoscopic hernioplasty when required hospital stay
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Aug 2015
- Primary completion30 Jun 2018
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scaravonati, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504461
- Sponsor's protocol ID
- 5614
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I have not decided yet. Maybe some data could be share to other researchers
Publications
Jenkins JT, O'Dwyer PJ. Inguinal hernias. BMJ. 2008 Feb 2;336(7638):269-72. doi: 10.1136/bmj.39450.428275.AD. No abstract available.
PubMed 18244999Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, Reda D, Henderson W; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004 Apr 29;350(18):1819-27. doi: 10.1056/NEJMoa040093. Epub 2004 Apr 25.
PubMed 15107485Payne JH Jr, Grininger LM, Izawa MT, Podoll EF, Lindahl PJ, Balfour J. Laparoscopic or open inguinal herniorrhaphy? A randomized prospective trial. Arch Surg. 1994 Sep;129(9):973-9; discussion 979-81. doi: 10.1001/archsurg.1994.01420330087016.
PubMed 8080380Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009 Aug;13(4):343-403. doi: 10.1007/s10029-009-0529-7. Epub 2009 Jul 28.
PubMed 19636493Miserez M, Peeters E, Aufenacker T, Bouillot JL, Campanelli G, Conze J, Fortelny R, Heikkinen T, Jorgensen LN, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Simons MP. Update with level 1 studies of the European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2014 Apr;18(2):151-63. doi: 10.1007/s10029-014-1236-6. Epub 2014 Mar 20.
PubMed 24647885McCloud JM, Evans DS. Day-case laparoscopic hernia repair in a single unit. Surg Endosc. 2003 Mar;17(3):491-3. doi: 10.1007/s00464-002-9093-2. Epub 2002 Nov 6.
PubMed 12415338
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Laparoscopic Inguinal Hernioplasty: Feasibility and Cost Minimization Analysis in a South American Hospital
- ClinicalTrials.gov ID
- NCT04504461
- Acronym / sponsor ID
- 5614
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 7 Aug 2020 (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.
Laparoscopic inguinal hernia repair has become one of the elective techniques, attributing the advantages of minimally invasive procedures to it. However, the high costs related to the need for hospitalization and materials make them a limitation at the time of its indication.
The objective is to evaluate the feasibility of performing this procedure in an outpatient surgery center and the cost analysis of an outpatient procedure regarding the same in the setting of hospitalization.
Detailed description
A retrospective analysis was performed on a prospective database in which all patients older than 18 years were included, in which a laparoscopic inguinal hernioplasty was performed in the period between August 2015 and June 2018 in the unit of ambulatory surgery of the Hospital Italiano de Buenos Aires. The same corresponds to an autonomous unit controlled by a health facility with hospitalization, as established by the Asociación Argentina de Cirugía in the Organization Guide and procedures in Ambulatory Surgery.
Laparoscopic repair using a transabdominal preperitoneal technique (TAPP) was proposed for patients with a clinical diagnosis of bilateral inguinal hernia or a recurrent unilateral hernia operated primarily through the anterior approach following the indications for laparoscopic surgery proposed by the European Hernia Society
The demographic data of the patients considered for this study were: age, gender, body mass index (BMI), anesthetic risk according to ASA (American Society of Anesthesiologists) score, comorbidities, bilateral primary or unilateral recurrent hernia, history of previous abdominal surgeries and associated midline hernias The details of the surgical procedure and the ambulatory surgery regimen, as well as possible postoperative complications, were explained to all patients in the preoperative consultation and an informed consent was signed.
The anesthetic technique was the same for everyone. The patients were operated under general anesthesia. Anesthetic induction was performed with propofol 2 mg / kg EV and fentanyl 2 ug / kg EV. Rocuronium 0.6 mg / kg EV was used to facilitate laryngeal mask placement. The anesthetic level was maintained with air, oxygen, sevoflorane at 1.5% expired and with remifentanil (0.25 at 0.5 ug / kg / min) based on the demand of the patient's plan. It was ventilated mechanically in controlled mode. As intraoperative analgesia, ketorolac 1 mg / kg according to renal function or diclofenac 1 mg / kg was used in patients with a history of bronchospasm. This was associated with 8 mg of dexamethasone. Antibiotic prophylaxis during anesthetic induction was performed with cefazolin 2 gr / kg EV.
In 100% of the cases, the surgical technique used was TAPP. The patient was asked to urinate prior to the transfer to the operating room to avoid the placement of a urinary catheter.
With the patient in the supine position, pneumoperitoneum was performed by umbilical scar with closed Veress needle technique. The abdomen was insufflated with a pressure of 12 mmHg. A 10-mm trocar was placed at the umbilical level and two 5-mm trocars were placed on both flanks outside the rectus sheath. In the event that the patient presents with an associated midline hernia, optic trocar was inserted due to hernia defect. It was approached first on one side and then on the contralateral side. After the opening of the peritoneum, dissection of the preperitoneal space and reduction of the hernial content, a polypropylene mesh (Prolene®, Ethicon Johnson \& Johnson) of 15 x 12 centimeters was placed covering the myopectineal orifice from the symphysis pubis medially, until the anterosuperior iliac spine laterally. In patients with bilateral hernia, two meshes were placed, one on each side respectively, surpassing the midline. The mesh was fixed with tuckers made of resorbable material (Securetrap®) or unabsorbable material (Protack®) according to the preference of the surgeon in charge of the procedure. The peritoneum was closed with continuous suture of slow absorbable material (Vycril®) or slow reabsorbed barb suture (Stratafix®). Local infiltration of all wounds was performed with ropivacaine at a dose of 3 mg / kg.
Surgical time was recorded as intraoperative variables, which was defined as minutes from the preparation of the surgical site to the closure of the skin; the type of hernia according to Nyhus classification and the presence of intraoperative complications.
At the end of the procedure, the patients were transferred to the recovery room. During the postoperative recovery an analgesic scheme was stipulated according to need. The rescues were made according to the evaluation of the nurse and the treating anesthetist and consisted of the following levels:
- First level: ketorolac 30 mg EV or diclofenac 75 mg EV. In patients with decreased glomerular filtration, paracetamol 1000 mg EV was used.
- Second level: morphine 1 - 3 mg EV. When the requirements of the ambulatory surgery guide of the Asociación Argentina de Cirugía listed in table N° 1 were fulfilled, the patient was discharged from hospital. The same was in charge of the responsible surgeon, who delivered the postoperative indications verbally and in writing, confirming the understanding of them by the patient and the companion.
The length of stay in the unit was recorded, as well as the need to administer analgesics during the same and pain according to the visual analog scale (EVA) at discharge.
Feasibility is expressed as the percentage of patients who were referred from the outpatient surgery unit.
The data about postoperative complications were collected prospectively through ambulatory controls previously stipulated at 7, 30, 180 and 360 days. They are classified into early (up to 30 days of the procedure) and late. The first included seroma, surgical site infection and hematoma; and late trocar hernias, recurrence and postoperative pain. Chronic postoperative pain is one that persists beyond the third month after the procedure.
In the first ambulatory control consultation at 7 days, patients were asked to rate their level of satisfaction with the procedure by choosing one of the four categories: not satisfied, not very satisfied, satisfied and very satisfied For the study of costs in addition to outpatients, those patients who underwent laparoscopic inguinal hernia in the inpatient setting during the period analyzed were included in the analysis. In this way, two branches of study were drawn up, one corresponding to patients operated on an outpatient basis and the other to patients operated through a hospital regimen.
Being a surgical procedure performed under a different hospital regime, a cost minimization study was carried out taking the average cost of performing an ambulatory procedure versus the same requiring admission.
When considering the economic situation of the República Argentina in the time under study (devaluation of the peso argentino weight of 100% and inflation of approximately 30% per year), continuous patients operated between December 2016 and April 2017 were taken, which represents the average of the period under study, as representative samples of each branch. For each patient, the surgical time, the persistence time in the ambulatory anesthetic recovery room or the hospitalization room, and the time of postoperative hospitalization were recorded in a database.
The materials used during surgery and anesthesia were previously standardized so that all the patients who underwent this procedure used the same resources.
The cost department of the Hospital Italiano de Buenos Aires was responsible for collecting the costs of each of these patients. They were divided into fixed costs per procedure, per hour/operating room, per hour in the ambulatory surgery recovery room, per hour in the recovery room of the central operating room and per day of hospitalization.
The costs were calculated in Argentine Pesos (AP) and converted into US Dollars (USD) taking into account the exchange rate in January 2017: 1 USD = 16.30 PA.
The categorical data were described as percentages and the quantitative data as mean and standard deviation or median and interquartile range according to the observed distribution. To compare means of quantitative variables, Student's t-test or Mann-Whitney U test was used according to the observed distribution. Chi-square or Fisher's test was used for the rest of the variables. A p <.05 was considered significant.
Regression models were constructed to adjust for confounding potentials.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Inguinal Hernioplasty. Ambulatory | – | Other: Analysis of feasibility and costsLaparoscopic Inguinal Hernioplasty performed in ambulatory surgery center |
| Laparoscopic Inguinal Hernioplasty. Hospital Stay | – | Other: Analysis of feasibility and costsLaparoscopic Inguinal Hernioplasty that have to stay at least 24 hours at the hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 with no major comorbidities that required a laparoscopic inguinal hernioplasty
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 |
|---|---|---|
| Analysis of feasibility and costsAnalyze the feasibility and costs of performing laparoscopic inguinal hernioplasty in an ambulatory surgery center | Other | Laparoscopic Inguinal Hernioplasty. Ambulatory, Laparoscopic Inguinal Hernioplasty. Hospital Stay |
Primary outcome
Incidence of surgical Complications
Time frame: Patients follow up is 12 month
Incidence of seroma, Incidence of hematoma, % of reoperation, incidence of wound infection
Costs of the procedure
Time frame: One month after surgery
Cost of laparoscopic hernioplasty in ambulatory surgery center. Cost of laparoscopic hernioplasty when required hospital stay
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 1 Dec 2020.
- Background: PubMed 18244999Jenkins JT, O'Dwyer PJ. Inguinal hernias. BMJ. 2008 Feb 2;336(7638):269-72. doi: 10.1136/bmj.39450.428275.AD. No abstract available.
- Background: PubMed 15107485Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, Reda D, Henderson W; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004 Apr 29;350(18):1819-27. doi: 10.1056/NEJMoa040093. Epub 2004 Apr 25.
- Background: PubMed 8080380Payne JH Jr, Grininger LM, Izawa MT, Podoll EF, Lindahl PJ, Balfour J. Laparoscopic or open inguinal herniorrhaphy? A randomized prospective trial. Arch Surg. 1994 Sep;129(9):973-9; discussion 979-81. doi: 10.1001/archsurg.1994.01420330087016.
- Background: PubMed 19636493Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009 Aug;13(4):343-403. doi: 10.1007/s10029-009-0529-7. Epub 2009 Jul 28.
- Background: PubMed 24647885Miserez M, Peeters E, Aufenacker T, Bouillot JL, Campanelli G, Conze J, Fortelny R, Heikkinen T, Jorgensen LN, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Simons MP. Update with level 1 studies of the European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2014 Apr;18(2):151-63. doi: 10.1007/s10029-014-1236-6. Epub 2014 Mar 20.
- Background: PubMed 12415338McCloud JM, Evans DS. Day-case laparoscopic hernia repair in a single unit. Surg Endosc. 2003 Mar;17(3):491-3. doi: 10.1007/s00464-002-9093-2. Epub 2002 Nov 6.
- Individual participant dataSharing planned: Undecided. I have not decided yet. Maybe some data could be share to other researchers
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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.
Scaravonati principal investigator
Hospital Italiano de Buenos Aires
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 Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Dec 2020. 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 Argentina. 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?
Incidence of surgical Complications (time frame: Patients follow up is 12 month). 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?
On the ClinicalTrials.gov record for NCT04504461, which also lists 6 linked publications.
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 1 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.