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

NCT03411226 | Completed

• 1 other identifier: 01012006
• Study Type: observational
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Recurrent Inguinal Hernia

Keywords

Inguinal Hernia; TREPP; Recurrence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Re-recurrence rate

  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

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

• Sexual complaints related to re-TREPP

  This was assessed between >30 days postoperative and the moment of evaluation (up to 95 months postoperative).

Study Arms (1)

re-TREPP

Patients who presented with a recurrent inguinal hernia after previous TREPP repair.

Procedure: re-TREPP

Interventions

re-TREPP PROCEDURE

repeated hernia repair via the TREPP technique

re-TREPP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients who had developed a recurrent inguinal hernia and had undergone a re-TREPP.

You may not qualify if:

• Children (age \<18 years)

Sponsors & Collaborators

• Alexandra Persoon: lead

MeSH Terms

Conditions

Hernia, Inguinal; Recurrence

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Giel G Koning, MSc, PhD

  St Jansdal Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Drs. A.M. Persoon

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 26, 2018
• Study Start: November 27, 2015
• Primary Completion: December 10, 2015
• Study Completion: January 31, 2016
• Last Updated: January 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share