Robotic Utility for Surgical Treatment of Umbilical Hernias

Completed

• Conditions: Hernia, Umbilical

• Registration Number: NCT02975414
• Lead Sponsor: Filip Muysoms

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Status Verified: 2018-12
• Primary Completion: 2018-12-17
• Study Completion: 2018-12-17
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 40 patients selected and operated by the PI.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
duration of operation	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

Name	Time	Method
Questionnaire about the Quality of Life	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.
intra-operative complications	until 4 weeks post-operative	Intra-operative complications registered until 4 weeks after the hernia repair
post-operative complications	until 1 year post-operative	Post-operative complications detected until 1 year after hernia repair by clinical follow up.

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Ghent, Belgium