NCT02975414

Brief Summary

The purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic assisted surgery for the treatment of incisional hernia's of 40 patients treated in Maria Middelares in laparoscopic rTARUP technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Typical duration 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

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed
Last Updated

December 24, 2018

Status Verified

December 1, 2018

Enrollment Period

2.3 years

First QC Date

October 24, 2016

Last Update Submit

December 21, 2018

Conditions

Hernia, Umbilical

Outcome Measures

Primary Outcomes (1)

  • duration of operation

    Recording of the operation time needed for robot-assisted TARUP umbilical hernia repair

    from the start of the operation until the end of the operation, approximately 4 hours

Secondary Outcomes (3)

  • intra-operative complications

    until 4 weeks post-operative

  • post-operative complications

    until 1 year post-operative

  • Questionnaire about the Quality of Life

    until 1 year post-operative

Interventions

rTARUP techniquePROCEDURE

obot-assisted rTARUP technique

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible patients who are scheduled for laparoscopic repair of an umbillical hernia. A total of 40 patients will be enrolled in this observational study.

You may qualify if:

  • patients selected and operated by the PI.

You may not qualify if:

  • patients under the age of 18
  • pregnancy
  • no Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Related Publications (1)

  • Muysoms F, Van Cleven S, Pletinckx P, Ballecer C, Ramaswamy A. Robotic transabdominal retromuscular umbilical prosthetic hernia repair (TARUP): observational study on the operative time during the learning curve. Hernia. 2018 Dec;22(6):1101-1111. doi: 10.1007/s10029-018-1825-x. Epub 2018 Sep 22.

    PMID: 30244344DERIVED

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Filip Muysoms, MD, PhD

    Maria Middelares hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
surgeon

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 29, 2016

Study Start

September 1, 2016

Primary Completion

December 17, 2018

Study Completion

December 17, 2018

Last Updated

December 24, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)