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

Recurrent Inguinal Hernia Clinical Trial

— re-TREPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411226
• Other study ID #: 01012006
• Status: Completed
• Phase: N/A
• First received: January 4, 2018
• Last updated: January 25, 2018
• Start date: November 27, 2015
• Est. completion date: January 31, 2016

Study information

• Verified date: January 2018
• Source: St Jansdal Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 31, 2016
• Est. primary completion date: December 10, 2015
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Recurrent Inguinal Hernia

Intervention

Procedure:
• re-TREPP
repeated hernia repair via the TREPP technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alexandra Persoon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic postoperative inguinal pain according to Visual Analogue Scale.	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.	This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).
Primary	Chronic postoperative pain according to Pain Disability Index	All patients who reported chronic pain (>30 days postoperative) were asked to fill out the Pain Disability Index questionnaire.	This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).
Secondary	Re-recurrence rate	The number of second recurrences after re-TREPP repair	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).
Secondary	Short term complications	Short term complications included: hematoma, wound infection, re-admission rate, medical complications and death. These complications were retrospectively analyzed via the electronic patient files.	Complications occuring from the start of the operation up to 30 days postoperative.
Secondary	Sexual complaints related to re-TREPP	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'.	This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).