Robotic Utility for Surgical Treatment of Groin Hernias

Hernia, Inguinal Clinical Trial

— Robust _1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975401
• Other study ID #: Robust_1
• Status: Completed
• Phase: N/A
• First received: October 24, 2016
• Last updated: July 24, 2017
• Start date: September 2016
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• 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 inguinal hernia`s of 50 patients treated in Maria Middelares in laparoscopic rTAPP technique.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• rTAPP technique
robot-assisted rTAPP technique

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of the operation	Recording of the operation time needed for robot-assisted TAPP groin hernia repair	from the start of the operation until the end of the operation, approximately 3 hours
Secondary	intra-operative complications	Intra-operative complications registered until 4 weeks post-operative	until 4 weeks post-operative
Secondary	post-operative complications	Post-operative complications detected until 4 weeks after hernia repair by clinical follow up.	until 4 weeks post-operative
Secondary	Quality of Life	Quality of Life measured with the EuraHS QoL score preoperative and until 4 weeks after hernia repair by clinical follow up.	until 4 weeks post-operative