Clinical Trials Directory

Trials / Completed

CompletedNCT02975401

Robotic Utility for Surgical Treatment of Groin Hernias

Prospective Observational Cohort Study on Robot-assisted Laparoscopic Hernia Repair (rTAPP)

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Algemeen Ziekenhuis Maria Middelares · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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 inguinal hernia's of 50 patients treated in Maria Middelares in laparoscopic rTAPP technique.

Detailed description

Minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients in Maria Middelares, Ghent. A previously conducted study demonstrated that the symptoms of patients with inguinal hernias (verified via EuraHS Quality of Life score) can be effectively treated and the technique has a low recurrence rate and low frequency of long-term side effects. 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 TAPP inguinal 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 inguinal hernias by 50 patients in Maria Middelares hospital.

Conditions

Interventions

TypeNameDescription
PROCEDURErTAPP techniquerobot-assisted rTAPP technique

Timeline

Start date
2016-09-01
Primary completion
2017-05-01
Completion
2017-05-01
First posted
2016-11-29
Last updated
2017-07-25

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT02975401. Inclusion in this directory is not an endorsement.