Recurrent Inguinal Herniare-TREPPNCT03411226
Feasibility of Re-TREPP in Patients With a Recurrent Inguinal Hernia After Previous TREPP Repair
An observational study of Recurrent Inguinal Hernia, run by Alexandra Persoon.
Trial summary
The Trans REctussheath PrePeritoneal (TREPP) mesh repair was introduced in 2006 to decrease the risk of postoperative inguinal pain in hernia surgery. For the repair of a recurrent inguinal hernia after a primary TREPP an alternative open anterior route (Lichtenstein) may seem the most logical option, but coincides… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Inguinal Hernia
- What is being tested?
- re-TREPP
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 27 Nov 2015to 31 Jan 2016
- 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
- Adult, Older adult
Study population: From all re-TREPP patients (n=19), the mean age at time of the re-operation was 68 years (range 56-86 years). All included patients, 18 males and 1 female, were classified with the American Society of Anesthesiologists (ASA) classification ≤3.
Who may be able to join
- Adult patients who had developed a recurrent inguinal hernia and had undergone a re-TREPP.
Who cannot join
- Children (age <18 years)
- Exclusion criterium for long term follow up: no informed consent obtained.
About this study
Official title: Management of Recurrent Inguinal Hernia After Previous Open Preperitoneal Repair: Is Re-TREPP Feasible?
The Trans REctussheath PrePeritoneal (TREPP) mesh repair was introduced in 2006 to decrease the risk of postoperative inguinal pain in hernia surgery. For the repair of a recurrent inguinal hernia after a primary TREPP an alternative open anterior route (Lichtenstein) may seem the most logical option, but coincides with an increased risk of chronic postoperative inguinal pain. Therefore, this study aimed to evaluate the feasibility of a second TREPP procedure to repair a recurrent inguinal hernia after an initial TREPP repair. The hypothesis was that the technique is possible and does not lead to an increased risk of postoperative pain.
Read the detailed description
Since the development and introduction of TREPP in 2006, TREPP has been the standard operation technique for all patients who present in St. Jansdal Hospital with an inguinal hernia. The electronic patient files of all consecutive patients who were operated at the St Jansdal hospital via TREPP between January 2006 and December 2013 were retrospectively investigated. This patient list was retrieved by an electronic search using the assigned operation codes. Adult patients who had developed a recurrent inguinal hernia and had undergone a re-TREPP were included in this study. A case report form was filled in for each patient that underwent a re-TREPP. Baseline data such as operation time, Body Mass Index (BMI), operation technique, number of conversions, aetiology of the recurrence, type of anesthesia and American Society of Anesthesiology (ASA) classification were retrospectively reviewed through patient files and operation reports. Co-morbidities were extracted from the files. Information on short term complications was taken from the notes of telephone consultation 2 and 30 days postoperatively, which is the local standard protocol for follow-up. Patients were invited for a long-term follow-up (>30 days postoperative) at the outpatient department for physical examination, or they were visited at home by the investigator. Written informed consent was obtained from all patients who were included for a long term follow-up. A case report form was used for each patient, in order to standardize the investigation. All patients were asked if they experienced any pain or discomfort. If there was pain, the Visual Analogue Scale and Pain Disability Index questionnaire were filled in. All patients were asked if sexual complaints occurred since the operation. Written informed consent was obtained from all patients who were clinically evaluated. Recurrent inguinal hernia was defined as a reappearance of the inguinal hernia, diagnosed by physical examination (a reducible bulge with positive Valsalva).
This was a retrospective case series. Since the numbers were small, no statistical analysis was performed.
- Conditions
- Recurrent Inguinal Hernia
- Being tested
- re-TREPP
- Keywords
- Inguinal Hernia, TREPP, Recurrence
- Medical subject headings
- Hernia, Inguinal, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
re-TREPPProcedure or surgery
repeated hernia repair via the TREPP technique
| Study group | Role | What they receive |
|---|---|---|
| re-TREPP | Patients who presented with a recurrent inguinal hernia after previous TREPP repair. Receives: Procedure: re-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 Analogue Scale.
All patients who reported chronic pain (>30 days postoperative) were asked to fill out the Visual Analogue Scale. This was a horizontal line of 100 millimeters long. Patients were asked to mark the point that indicated the amount of pain that they experienced. The length between the left anchor 'no pain' and the patients mark was measured, providing a range of 0 to 100. A greater score indicated greater pain intensity.
Measured: This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).
Chronic postoperative pain according to Pain Disability Index
All patients who reported chronic pain (>30 days postoperative) were asked to fill out the Pain Disability Index questionnaire.
Measured: This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).
Secondary outcomes (3)
Re-recurrence rate
The number of second recurrences after re-TREPP repair
Measured: This was assessed by reviewing the electronic patient files and via a physical examination at the long term follow-up (ranging from >30 days postoperative, up to 95 months postoperative).
Short term complications
Short term complications included: hematoma, wound infection, re-admission rate, medical complications and death. These complications were retrospectively analyzed via the electronic patient files.
Measured: Complications occuring from the start of the operation up to 30 days postoperative.
Sexual complaints related to re-TREPP
All patients were asked if they experienced any sexual problems related to the re-TREPP surgery. The question was answered with 'yes', 'no' or 'not sure'.
Measured: This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start27 Nov 2015
- Primary completion10 Dec 2015
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandra Persoon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexandra Persoon, St Jansdal Hospital
- Investigators
- Giel G Koning, MSc, PhD, Study chair, St Jansdal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411226
- Sponsor's protocol ID
- 01012006
- Acronym
- re-TREPP
- Status last verified
- Jan 2018
- First submitted
- 4 Jan 2018
- Last updated
- 29 Jan 2018
- Results posted
- 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 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Recurrent Inguinal Hernia After Previous Open Preperitoneal Repair: Is Re-TREPP Feasible?
- ClinicalTrials.gov ID
- NCT03411226
- Acronym / sponsor ID
- re-TREPP / 01012006
- Conditions
- Recurrent Inguinal Hernia
- Keywords
- Inguinal Hernia, TREPP, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Alexandra PersoonUniversity, hospital or other
- Study start
- 27 Nov 2015 (actual)
- Primary completion
- 10 Dec 2015 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 26 Jan 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.
The Trans REctussheath PrePeritoneal (TREPP) mesh repair was introduced in 2006 to decrease the risk of postoperative inguinal pain in hernia surgery. For the repair of a recurrent inguinal hernia after a primary TREPP an alternative open anterior route (Lichtenstein) may seem the most logical option, but coincides with an increased risk of chronic postoperative inguinal pain. Therefore, this study aimed to evaluate the feasibility of a second TREPP procedure to repair a recurrent inguinal hernia after an initial TREPP repair. The hypothesis was that the technique is possible and does not lead to an increased risk of postoperative pain.
Detailed description
Since the development and introduction of TREPP in 2006, TREPP has been the standard operation technique for all patients who present in St. Jansdal Hospital with an inguinal hernia. The electronic patient files of all consecutive patients who were operated at the St Jansdal hospital via TREPP between January 2006 and December 2013 were retrospectively investigated. This patient list was retrieved by an electronic search using the assigned operation codes. Adult patients who had developed a recurrent inguinal hernia and had undergone a re-TREPP were included in this study. A case report form was filled in for each patient that underwent a re-TREPP. Baseline data such as operation time, Body Mass Index (BMI), operation technique, number of conversions, aetiology of the recurrence, type of anesthesia and American Society of Anesthesiology (ASA) classification were retrospectively reviewed through patient files and operation reports. Co-morbidities were extracted from the files. Information on short term complications was taken from the notes of telephone consultation 2 and 30 days postoperatively, which is the local standard protocol for follow-up. Patients were invited for a long-term follow-up (>30 days postoperative) at the outpatient department for physical examination, or they were visited at home by the investigator. Written informed consent was obtained from all patients who were included for a long term follow-up. A case report form was used for each patient, in order to standardize the investigation. All patients were asked if they experienced any pain or discomfort. If there was pain, the Visual Analogue Scale and Pain Disability Index questionnaire were filled in. All patients were asked if sexual complaints occurred since the operation. Written informed consent was obtained from all patients who were clinically evaluated. Recurrent inguinal hernia was defined as a reappearance of the inguinal hernia, diagnosed by physical examination (a reducible bulge with positive Valsalva).
This was a retrospective case series. Since the numbers were small, no statistical analysis was performed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| re-TREPP | – | Procedure: re-TREPPPatients who presented with a recurrent inguinal hernia after previous TREPP repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- From all re-TREPP patients (n=19), the mean age at time of the re-operation was 68 years (range 56-86 years). All included patients, 18 males and 1 female, were classified with the American Society of Anesthesiologists (ASA) classification ≤3.
Key inclusion criteria (1 listed)
- Adult patients who had developed a recurrent inguinal hernia and had undergone a re-TREPP.
Key exclusion criteria (2 listed)
- Children (age <18 years)
- Exclusion criterium for long term follow up: no informed consent obtained.
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 |
|---|---|---|
| re-TREPPrepeated hernia repair via the TREPP technique | Procedure or surgery | re-TREPP |
Primary outcome
Chronic postoperative inguinal pain according to Visual Analogue Scale.
Time frame: This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).
All patients who reported chronic pain (>30 days postoperative) were asked to fill out the Visual Analogue Scale. This was a horizontal line of 100 millimeters long. Patients were asked to mark the point that indicated the amount of pain that they experienced. The length between the left anchor 'no pain' and the patients mark was measured, providing a range of 0 to 100. A greater score indicated greater pain intensity.
Chronic postoperative pain according to Pain Disability Index
Time frame: This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).
All patients who reported chronic pain (>30 days postoperative) were asked to fill out the Pain Disability Index questionnaire.
3 secondary outcomes
Re-recurrence rate
Time frame: This was assessed by reviewing the electronic patient files and via a physical examination at the long term follow-up (ranging from >30 days postoperative, up to 95 months postoperative).
Short term complications
Time frame: Complications occuring from the start of the operation up to 30 days postoperative.
Sexual complaints related to re-TREPP
Time frame: This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).
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 29 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Giel G Koning, MSc, PhD study chair
St Jansdal Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Inguinal Hernia, run by Alexandra Persoon.
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 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Analogue Scale. (time frame: This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).). 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 29 Jan 2018.