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

Strangulated Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935490
• Other study ID #: 201900143
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: July 12, 2019

Study information

• Verified date: March 2020
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 12, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Strangulated Inguinal Hernia

Intervention

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.

Locations

Country	Name	City	State
Netherlands	St Jansdal Hospital	Harderwijk	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	St Jansdal Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Short-term complications	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.	Complications occuring from the start of the operation up to 30 days postoperative
Secondary	Sexual complaints related to e-TREPP	All patients will be asked if they experienced any sexual problems related to the e-TREPP surgery.	Between >30 days postoperatively and through study completion, average 6 years