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Completed

NCT Number: NCT03935490

The Transrectus Sheath Pre-peritoneal (TREPP) Technique for Strangulated Inguinal Hernia: a Case-series

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.

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Key information

Conditions

Strangulated Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Jansdal Hospital

Harderwijk, Gelderland, 3844 DG, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Emergency surgery for suspected strangulated inguinal hernia (within 6 hours after admission)
  • e-TREPP performed

Exclusion criteria

  • No emergency surgery (for instance, surgery day after admission or later).
  • No e-TREPP performed

Treatment and study plan

emergency transrectus sheath pre-peritoneal mesh repair (e-TREPP)

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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 will be retrospectively analyzed via the electronic patient files. They will be verified at the outpatient department.

  2. Sexual complaints related to e-TREPP

    Time frame: Between >30 days postoperatively and through study completion, average 6 years

    All patients will be asked if they experienced any sexual problems related to the e-TREPP surgery.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • St Jansdal Hospital

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 2, 2019
Registry last updated
Mar 26, 2020

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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