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NCT Number: NCT03411226

Feasibility of Re-TREPP in Patients With a Recurrent Inguinal Hernia After Previous TREPP Repair

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients who had developed a recurrent inguinal hernia and had undergone a re-TREPP.

Exclusion criteria

  • Children (age <18 years)
  • Exclusion criterium for long term follow up: no informed consent obtained.

Treatment and study plan

re-TREPP

Procedure

repeated hernia repair via the TREPP technique

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

    The number of second recurrences after re-TREPP repair

  2. Short term complications

    Time frame: Complications occuring from the start of the operation up to 30 days postoperative.

    Short term complications included: hematoma, wound infection, re-admission rate, medical complications and death. These complications were retrospectively analyzed via the electronic patient files.

  3. 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).

    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'.

Sponsors and collaborators

Lead sponsor

Alexandra Persoon

Other

Registry information

Official study title

Management of Recurrent Inguinal Hernia After Previous Open Preperitoneal Repair: Is Re-TREPP Feasible?

Acronym: re-TREPP

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jan 26, 2018
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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