An observational study in Recurrent Inguinal Hernia, sponsored by Alexandra Persoon. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-29.
Sponsored by Alexandra Persoon · Observational
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.
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.
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
This study's enrollment of 19 is below the median of 134 across 137 observational studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →This is the only study on the registry with Alexandra Persoon as lead sponsor.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who presented with a recurrent inguinal hernia after previous TREPP repair.
Procedure: re-TREPP
repeated hernia repair via the TREPP technique
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.
Time frame: 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.
Time frame: This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).
Re-recurrence rate
The number of second recurrences after re-TREPP repair
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
Short term complications included: hematoma, wound infection, re-admission rate, medical complications and death. These complications were retrospectively analyzed via the electronic patient files.
Time frame: 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'.
Time frame: This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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