NCT03935490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

April 29, 2019

Last Update Submit

March 25, 2020

Conditions

Keywords

Inguinal herniaStrangulatedTREPPTransrectus sheath pre-peritoneal

Outcome Measures

Primary Outcomes (2)

  • Chronic postoperative inguinal pain according to Visual Analog Scale

    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.

    From surgery date up to 12 years postoperatively

  • Recurrence rate

    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.

    From surgery date up to 12 years postoperatively

Secondary Outcomes (2)

  • Short-term complications

    Complications occuring from the start of the operation up to 30 days postoperative

  • Sexual complaints related to e-TREPP

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

Study Arms (1)

e-TREPP

Patients with strangulated inguinal hernia treated with e-TREPP

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

Interventions

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.

e-TREPP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Jansdal Hospital

Harderwijk, Gelderland, 3844 DG, Netherlands

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 2, 2019

Study Start

May 1, 2019

Primary Completion

July 1, 2019

Study Completion

July 12, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations