Strangulated Inguinal HerniaNCT03935490
The Transrectus Sheath Pre-peritoneal (TREPP) Technique for Strangulated Inguinal Hernia: a Case-series
An observational study of Strangulated Inguinal Hernia, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
n the Sint Jansdal Hospital in Harderwijk, the Netherlands, the TREPP technique is the standard operating procedure for patients with inguinal hernia. Starting from 2006, this procedure has also been used on patients that presented with an acute strangulated inguinal hernia in the emergency department, instead of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Strangulated Inguinal Hernia
- What is being tested?
- emergency transrectus sheath pre-peritoneal mesh repair (e-TREPP)
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2019to 12 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: From all acute inguinal hernia repairs patient records will searched for e-TREPP procedures. All patients will be asked to visit the outpatient department.
Who may be able to join
- Emergency surgery for suspected strangulated inguinal hernia (within 6 hours after admission)
- e-TREPP performed
Who cannot join
- No emergency surgery (for instance, surgery day after admission or later).
- No e-TREPP performed
Trial locations and contacts
1 site in 1 country.
About this study
n the Sint Jansdal Hospital in Harderwijk, the Netherlands, the TREPP technique is the standard operating procedure for patients with inguinal hernia. Starting from 2006, this procedure has also been used on patients that presented with an acute strangulated inguinal hernia in the emergency department, instead of the more common Lichtenstein technique. The goal of this retrospective case series is to assess the feasibility of the TREPP technique in case of an acute strangulated inguinal hernia. Patient records from 2006 until 2016 will be used to search for patients treated for acute inguinal hernia in that period. After applying the in- and exclusion criteria, patients who are eligible for inclusion will be contacted by telephone. They will be asked if they are willing to visit the surgical outpatient department once and fill out two questionnaires. The data of these questionnaires will be analyzed and published.
- Conditions
- Strangulated Inguinal Hernia
- Being tested
- emergency transrectus sheath pre-peritoneal mesh repair (e-TREPP)
- Keywords
- Inguinal hernia, Strangulated, TREPP, Transrectus sheath pre-peritoneal
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emergency transrectus sheath pre-peritoneal mesh repair (e-TREPP)Procedure or surgery
The Trans REctussheath PrePeritoneal mesh repair (TREPP) was developed in 2006 as an open preperitoneal technique to reduce CPIP. In short: a 4-5 centimeters (cm) transverse incision is made about 1 cm above the localization of the deep inguinal ring. The anterior rectus sheath is opened. After retracting the rectus muscle medially, the preperitoneal space (PPS) is bluntly dissected and a complete overview can be achieved. All possible hernia orifices can be visualized such as: a direct, indirect, pantaloon, and/or femoral hernia. A self-expandable mesh is then positioned in the PPS. Due to the "upstream principle" no mesh fixation is necessary.
| Study group | Role | What they receive |
|---|---|---|
| e-TREPP | Patients with strangulated inguinal hernia treated with e-TREPP Receives: Procedure: emergency transrectus sheath pre-peritoneal mesh repair (e-TREPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic postoperative inguinal pain according to Visual Analog Scale
Patients will be asked to fill out the VAS on a horizontal line of 10 millimeters long. Patients will be asked to mark the point that indicated the amount of pain they experience. The distance from the left marker will be measured, with increasing distance at greater pain intensity.
Measured: From surgery date up to 12 years postoperatively
Recurrence rate
Patient electronic records will be searched for re-operations for recurrent inguinal hernia. Also, patients will be asked in the outpatient department if they received recurrence surgery or suffer new complaints.
Measured: From surgery date up to 12 years postoperatively
Secondary outcomes (2)
Short-term complications
Short term complications included: hematoma, wound infection, re-admission rate, medical complications and death. These complications will be retrospectively analyzed via the electronic patient files. They will be verified at the outpatient department.
Measured: Complications occuring from the start of the operation up to 30 days postoperative
Sexual complaints related to e-TREPP
All patients will be asked if they experienced any sexual problems related to the e-TREPP surgery.
Measured: Between >30 days postoperatively and through study completion, average 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 May 2019
- Primary completion1 Jul 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strangulated 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- St Jansdal Hospital
- Responsible party
- Principal investigator, Thomas Zwols, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935490
- Sponsor's protocol ID
- 201900143
- Status last verified
- Mar 2020
- First submitted
- 29 Apr 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transrectus Sheath Pre-peritoneal (TREPP) Technique for Strangulated Inguinal Hernia: a Case-series
- ClinicalTrials.gov ID
- NCT03935490
- Acronym / sponsor ID
- 201900143
- Conditions
- Strangulated Inguinal Hernia
- Keywords
- Inguinal hernia, Strangulated, TREPP, Transrectus sheath pre-peritoneal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- St Jansdal Hospital
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 2 May 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.
n the Sint Jansdal Hospital in Harderwijk, the Netherlands, the TREPP technique is the standard operating procedure for patients with inguinal hernia. Starting from 2006, this procedure has also been used on patients that presented with an acute strangulated inguinal hernia in the emergency department, instead of the more common Lichtenstein technique. The goal of this retrospective case series is to assess the feasibility of the TREPP technique in case of an acute strangulated inguinal hernia. Patient records from 2006 until 2016 will be used to search for patients treated for acute inguinal hernia in that period. After applying the in- and exclusion criteria, patients who are eligible for inclusion will be contacted by telephone. They will be asked if they are willing to visit the surgical outpatient department once and fill out two questionnaires. The data of these questionnaires will be analyzed and published.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| e-TREPP | – | Procedure: emergency transrectus sheath pre-peritoneal mesh repair (e-TREPP)Patients with strangulated inguinal hernia treated with e-TREPP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From all acute inguinal hernia repairs patient records will searched for e-TREPP procedures. All patients will be asked to visit the outpatient department.
Key inclusion criteria (2 listed)
- Emergency surgery for suspected strangulated inguinal hernia (within 6 hours after admission)
- e-TREPP performed
Key exclusion criteria (2 listed)
- No emergency surgery (for instance, surgery day after admission or later).
- No e-TREPP performed
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 |
|---|---|---|
| emergency transrectus sheath pre-peritoneal mesh repair (e-TREPP)The Trans REctussheath PrePeritoneal mesh repair (TREPP) was developed in 2006 as an open preperitoneal technique to reduce CPIP. In short: a 4-5 centimeters (cm) transverse incision is made about 1 cm above the localization of the deep inguinal ring. The anterior rectus sheath is opened. After retracting the rectus muscle medially, the preperitoneal space (PPS) is bluntly dissected and a complete overview can be achieved. All possible hernia orifices can be visualized such as: a direct, indirect, pantaloon, and/or femoral hernia. A self-expandable mesh is then positioned in the PPS. Due to the "upstream principle" no mesh fixation is necessary. | Procedure or surgery | e-TREPP |
Primary outcome
Chronic postoperative inguinal pain according to Visual Analog Scale
Time frame: From surgery date up to 12 years postoperatively
Patients will be asked to fill out the VAS on a horizontal line of 10 millimeters long. Patients will be asked to mark the point that indicated the amount of pain they experience. The distance from the left marker will be measured, with increasing distance at greater pain intensity.
Recurrence rate
Time frame: From surgery date up to 12 years postoperatively
Patient electronic records will be searched for re-operations for recurrent inguinal hernia. Also, patients will be asked in the outpatient department if they received recurrence surgery or suffer new complaints.
2 secondary outcomes
Short-term complications
Time frame: Complications occuring from the start of the operation up to 30 days postoperative
Sexual complaints related to e-TREPP
Time frame: Between >30 days postoperatively and through study completion, average 6 years
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 26 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Strangulated Inguinal Hernia
Not yet recruitingObservational study
Development of Taxi Teaching for Strangled Inguinal Hernias in Children
Pediatric 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Strangulated Inguinal Hernia, run by University Medical Center Groningen at 1 site in Netherlands.
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 2 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 26 Mar 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 Netherlands. 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?
Chronic postoperative inguinal pain according to Visual Analog Scale (time frame: From surgery date up to 12 years postoperatively). 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 26 Mar 2020.