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

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Inguinal Hernia
• Intervention / Treatment: Procedure: re-TREPP

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 19

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From all re-TREPP patients (n=19), the mean age at time of the re-operation was 68 years (range 56-86 years). All included patients, 18 males and 1 female, were classified with the American Society of Anesthesiologists (ASA) classification ≤3.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
re-TREPP; Patients who presented with a recurrent inguinal hernia after previous TREPP repair.	Procedure: re-TREPP; repeated hernia repair via the TREPP technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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.
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).

Collaborators and Investigators

• Sponsor: Alexandra Persoon
• Investigators: Study Chair: Giel G Koning, MSc, PhD, St Jansdal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2015
• Primary Completion (Actual): December 10, 2015
• Study Completion (Actual): January 31, 2016

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Recurrence; Inguinal Hernia; TREPP
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Recurrence
• Other Study ID Numbers: 01012006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No