Robotic Utility for Surgical Treatment of Umbilical Hernias

Hernia, Umbilical Clinical Trial

— Robust_2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975414
• Other study ID #: Robust_2
• Status: Completed
• Start date: September 2016
• Est. completion date: December 17, 2018

Study information

• Verified date: December 2018
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 17, 2018
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 40 patients selected and operated by the PI.

Exclusion Criteria:

• patients under the age of 18

• pregnancy

• no Informed Consent

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical

Intervention

Procedure:
• rTARUP technique
obot-assisted rTARUP technique

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
Filip Muysoms

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	intra-operative complications	Intra-operative complications registered until 4 weeks after the hernia repair	until 4 weeks post-operative
Secondary	post-operative complications	Post-operative complications detected until 1 year after hernia repair by clinical follow up.	until 1 year post-operative
Secondary	Questionnaire about the Quality of Life	Quality of Life measured with the EuraHS QoL score preoperative and until 1 year after hernia repair by clinical follow up.	until 1 year post-operative