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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

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

Clinicaltrials.gov identifier NCT03935490

Recruitment Status Completed

First Posted May 2, 2019

Last update posted March 26, 2020

Study Description

Brief 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 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.

  • Condition or Disease:Strangulated Inguinal Hernia
  • Intervention/Treatment: Procedure: emergency transrectus sheath pre-peritoneal mesh repair (e-TREPP)
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 45 participants
  • Observational Model: Case-Only
  • Time Perspective: Retrospective
  • Official Title: The Transrectus Sheath Pre-peritoneal (TREPP) Technique for Strangulated Inguinal Hernia: a Case-series
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: July 2019
  • Actual Study Completion Date: July 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: e-TREPP
Patients with strangulated inguinal hernia treated with e-TREPP
Procedure: 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.
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • 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.
Criteria

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

Contacts and Locations
Contacts
Locations

Netherlands, Gelderland
St Jansdal Hospital
Harderwijk

Sponsors and Collaborators

University Medical Center Groningen

St Jansdal Hospital

More Information
  • Responsible Party: University Medical Center Groningen
  • ClinicalTrials.gov Identifier: NCT03935490 History of Changes
  • Other Study ID Numbers: 201900143
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: March 26, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University Medical Center Groningen: Inguinal hernia
    Strangulated
    TREPP
    Transrectus sheath pre-peritoneal
  • Additional relevant MeSH terms: Hernia Hernia, Inguinal