Clinical trial NCT02975414: Robotic Utility for Surgical Treatment of Umbilical Hernias
Official title: Prospective Observational Cohort Study of Robot-assisted Laparoscopic Hernia Umbilical Hernia Repair (rTARUP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Umbilical
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 40 patients selected and operated by the PI.

Exclusion Criteria:

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

Primary outcomes:
measure: duration of operation
timeFrame: from the start of the operation until the end of the operation, approximately 4 hours
Secondary outcomes:
measure: intra-operative complications
timeFrame: until 4 weeks post-operative
measure: post-operative complications
timeFrame: until 1 year post-operative
measure: Questionnaire about the Quality of Life
timeFrame: until 1 year post-operative
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
Study officials:
affiliation: Maria Middelares hospital
name: Filip Muysoms, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.