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Robotic Utility for Surgical Treatment of Umbilical Hernias (Robust_2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02975414
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Filip Muysoms, Algemeen Ziekenhuis Maria Middelares

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.

Condition or disease Intervention/treatment
Hernia, Umbilical Procedure: rTARUP technique

Detailed Description:

Minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients with an umbilical hernia larger than 2 cm in Maria Middelares, Ghent.

As previously described in a chapter in a surgical guide and in a review article on the surgical fixation technique for laparoscopic umbilical hernia repair, the used technique has been proven feasible end safe.

Robot-assisted laparoscopic surgery has become standard in urology for resection of the prostate carcinoma. In general abdominal surgery, a large group of surgeons are currently working on the introduction of robotic-assisted surgery for resection of colon and rectal cancer in their daily practice. The third generation robot (DaVinci Xi), has extended the applicability of this technology within the field of general surgery.

For the surgical treatment of hernia's and other abdominal wall defects (umbilical or/and incisional hernia's), currently only surgeons in the US have experiences in structured treatment programs.

From September 1, 2016 Maria Middelares hospital will introduce robot-assisted surgery, including the laparoscopic TARUP umbilical hernia repair.

Main obstacles to the introduction of robot technology in abdominal wall surgery are prolonged preparation time in the operating room required for installation of the robot, and higher material costs related to the robot-assisted surgery. However, there are few precise data available on the exact size of extra time or increased costs related to the introduction of robotic assisted surgery in a program for abdominal surgery.

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 umbilical hernias by 40 patients in Maria Middelares hospital.


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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Cohort Study of Robot-assisted Laparoscopic Hernia Umbilical Hernia Repair (rTARUP)
Study Start Date : September 2016
Actual Primary Completion Date : December 17, 2018
Actual Study Completion Date : December 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia


Intervention Details:
  • Procedure: rTARUP technique
    obot-assisted rTARUP technique


Primary Outcome Measures :
  1. duration of operation [ Time Frame: from the start of the operation until the end of the operation, approximately 4 hours ]
    Recording of the operation time needed for robot-assisted TARUP umbilical hernia repair


Secondary Outcome Measures :
  1. intra-operative complications [ Time Frame: until 4 weeks post-operative ]
    Intra-operative complications registered until 4 weeks after the hernia repair

  2. post-operative complications [ Time Frame: until 1 year post-operative ]
    Post-operative complications detected until 1 year after hernia repair by clinical follow up.

  3. Questionnaire about the Quality of Life [ Time Frame: until 1 year post-operative ]
    Quality of Life measured with the EuraHS QoL score preoperative and until 1 year after hernia repair by clinical follow up.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 40 patients selected and operated by the PI.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975414


Locations
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Belgium
AZ Maria Middelares
Ghent, Belgium, 9000
Sponsors and Collaborators
Filip Muysoms
Investigators
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Principal Investigator: Filip Muysoms, MD, PhD Maria Middelares hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Filip Muysoms, surgeon, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier: NCT02975414     History of Changes
Other Study ID Numbers: Robust_2
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal