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Completed

NCT Number: NCT02975414

Robotic Utility for Surgical Treatment of Umbilical Hernias

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.

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Key information

Conditions

Hernia, Umbilical Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Hernia, Ventral Infant, Newborn, Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Maria Middelares

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 40 patients selected and operated by the PI.

Exclusion criteria

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

Treatment and study plan

rTARUP technique

Procedure

obot-assisted rTARUP technique

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Filip Muysoms

Other

Registry information

Official study title

Prospective Observational Cohort Study of Robot-assisted Laparoscopic Hernia Umbilical Hernia Repair (rTARUP)

Acronym: Robust_2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2016
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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