Repair of Groin Hernias After Abdominal Prostatectomy With Robotic TAPP

Inguinal Hernia Clinical Trial

— RAPrTAPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04718597
• Other study ID #: MMS.2020.067
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2021
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Robotic assisted inguinal hernia repair
Robotic assisted inguinal hernia repair with DaVinci Xi system instead of open repair
• Open inguinal hernia repair
Classical approach (open repair)

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

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