Clinical Trial: Robotic Utility for Surgical Treatment of Umbilical Hernias

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.

Detailed Summary:

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 ti
Sponsor: Filip Muysoms

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • intra-operative complications [ Time Frame: until 4 weeks post-operative ]
    Intra-operative complications registered until 4 weeks after the hernia repair
  • post-operative complications [ Time Frame: until 1 year post-operative ]
    Post-operative complications detected until 1 year after hernia repair by clinical follow up.
  • 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.


Original Secondary Outcome: Same as current

Information By: Algemeen Ziekenhuis Maria Middelares

Dates:
Date Received: October 24, 2016
Date Started: September 2016
Date Completion: April 2019
Last Updated: November 23, 2016
Last Verified: November 2016