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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02975401
Other study ID # Robust_1
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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