Repair of Groin Hernias After Abdominal Prostatectomy With Robotic TAPP

NCT04718597 | Completed

• 1 other identifier: MMS.2020.067
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Early complications at home

  Immediately post hospital discharge until 1 month postoperative

Study Arms (2)

Open hernia repair

Patients who underwent inguinal hernia repair via an open Liechtenstein procedure

Procedure: Open inguinal hernia repair

Robotic assisted hernia repair

Patients who underwent inguinal hernia repair via robotic assisted laparoscopy

Procedure: Robotic assisted inguinal hernia repair

Interventions

Robotic assisted inguinal hernia repair PROCEDURE

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

Robotic assisted hernia repair

Open inguinal hernia repair PROCEDURE

Classical approach (open repair)

Open hernia repair

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip Muysoms, PhD

  Algemeen Ziekenhuis Maria Middelares

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: January 22, 2021
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

BE (1)