Robotic Utility for Surgical Treatment of Groin Hernias

Completed

• Conditions: Hernia, Inguinal

• Registration Number: NCT02975401
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

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 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.

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
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 50 patients selected and operated by the PI.

Exclusion Criteria

• patients under the age of 18
• pregnancy
• BMI > 35
• recurrent groin hernia
• no Informed Consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
duration of the operation	from the start of the operation until the end of the operation, approximately 3 hours	Recording of the operation time needed for robot-assisted TAPP groin hernia repair

Secondary Outcome Measures

Name	Time	Method
intra-operative complications	until 4 weeks post-operative	Intra-operative complications registered until 4 weeks post-operative
post-operative complications	until 4 weeks post-operative	Post-operative complications detected until 4 weeks after hernia repair by clinical follow up.
Quality of Life	until 4 weeks post-operative	Quality of Life measured with the EuraHS QoL score preoperative and until 4 weeks after hernia repair by clinical follow up.

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Ghent, Belgium