Repair of Groin Hernias After Abdominal Prostatectomy With Robotic TAPP (RAPrTAPP)

Lichtenstein or Robotic TAPP Repair of Groin Hernias After Abdominal Prostatectomy: a Single Centre Retrospective Comparative Study

This retrospective study investigates if robotic assisted groin hernia repair in patients who previously underwent abdominal prostatectomy has an equal or more favorable clinical outcome, compared to open repair in those patients.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Open inguinal hernia repair; Procedure: Robotic assisted inguinal hernia repair

Detailed Description

In the personal practice of the investigators, there has been a decrease in open groin hernia repair from 17% to 6% since the introduction of robotic assisted surgery. This reflects a change in indication for complex hernias from an open to a minimal invasive approach. One of the typical indications for open approach before adopting the robotic platform were groin hernias after previous abdominal prostatectomy. Since prostatectomy results in scarring of the retropubic area where we need to dissect during MIS groin hernia repair, an open anterior approach is often suggested. With the enhanced view and instrument dexterity of the robotic platform, the investigators have now changed to a minimal invasive approach in these patients.

Therefore, this study will evaluate the clinical outcome after robotic assisted repair of groin hernias in patients who previously underwent an abdominal prostatectomy in comparison to open groin hernia repair.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • AZ Maria Middelares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent robotic assisted or open inguinal hernia repair in the period March 2015 - March 2020 and previously underwent an abdominal prostatectomy.

Description

Inclusion Criteria:

• Adult patients
• Underwent uni-or bilateral groin hernia repair in the period March 2015 - March 2020
• Groin hernia repair via robotic assisted laparoscopy or open surgery
• History of abdominal prostatectomy before the groin hernia repair

Exclusion Criteria:

• Age below 18
• Groin hernia repair via conventional laparoscopy
• Groin hernia repair via open surgery other than Liechtenstein method
• Groin hernia repair without mesh placement

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open hernia repair; Patients who underwent inguinal hernia repair via an open Liechtenstein procedure	Procedure: Open inguinal hernia repair; Classical approach (open repair)
Robotic assisted hernia repair; Patients who underwent inguinal hernia repair via robotic assisted laparoscopy	Procedure: Robotic assisted inguinal hernia repair; Robotic assisted inguinal hernia repair with DaVinci Xi system instead of open repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-hospital complications	Complications during hospital stay according to Clavien-Dindo	From admission until hospital discharge, on average 12-24 hours
Operative time and per-operative complications	Skin-to-skin operating time and complications during the procedure	During the hernia repair procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early complications at home	Complications at 1 month follow-up (readmission, seroma, infection) according to Clavien-Dindo	Immediately post hospital discharge until 1 month postoperative

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Filip Muysoms, PhD, Algemeen Ziekenhuis Maria Middelares

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: MMS.2020.067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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