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Completed

NCT Number: NCT04718597

Repair of Groin Hernias After Abdominal Prostatectomy With Robotic TAPP

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic assisted inguinal hernia repair

Procedure

Robotic assisted inguinal hernia repair with DaVinci Xi system instead of open repair

Open Inguinal Hernia Repair

Procedure

Classical approach (open repair)

Primary outcomes

  1. Intra-hospital complications

    Time frame: From admission until hospital discharge, on average 12-24 hours

    Complications during hospital stay according to Clavien-Dindo

  2. Operative time and per-operative complications

    Time frame: During the hernia repair procedure

    Skin-to-skin operating time and complications during the procedure

Secondary outcomes

  1. Early complications at home

    Time frame: Immediately post hospital discharge until 1 month postoperative

    Complications at 1 month follow-up (readmission, seroma, infection) according to Clavien-Dindo

Sponsors and collaborators

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Other

Registry information

Official study title

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

Acronym: RAPrTAPP

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 22, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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