NCT04431271

Brief Summary

The material cost for robotic groin hernia repair is higher than for conventional laparoscopic surgery. In this study, this amount will be quantified and possible differences in early postoperative course, hospital stay and readmission rate that could influence the cost/benefit ratio for robotic groin hernia surgery will be analyzed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
677

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

June 5, 2020

Last Update Submit

August 25, 2020

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Direct costs

    Material costs, hospitalization costs, specialist fees and costs related to early complications

    Immediately post hospital discharge

Secondary Outcomes (1)

  • Indirect costs

    0- 42 days postoperatively

Study Arms (2)

Robot-assisted laparoscopy

Patients who underwent robot-assisted groin hernia repair

Procedure: Robot-assisted hernia repair

Conventional laparoscopy

Patients who underwent conventional laparoscopic groin hernia repair

Interventions

Robot-assisted hernia repairPROCEDURE

Inguinal hernia repair was performed using the DaVinci Xi robotic system

Robot-assisted laparoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent uni-or bilateral groin hernia repair in the period 2015- 2019. Only patients who underwent minimal-invasive surgery (conventional or robot-assisted laparoscopy) will be included.

You may qualify if:

  • adult patients
  • underwent uni-or bilateral groin hernia repair in the period 2015- 2019
  • surgery through minimal invasive repair

You may not qualify if:

  • open surgery or conversion from minimal-invasive to open surgery
  • combined procedures
  • age below 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Filip Muysoms, MD, PhD

    Algemeen Ziekenhuis Maria Middelares

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 16, 2020

Study Start

June 1, 2020

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

August 27, 2020

Record last verified: 2020-08

Locations

BE(1)