Clinical trial NCT02975401: Robotic Utility for Surgical Treatment of Groin Hernias
Official title: Prospective Observational Cohort Study on Robot-assisted Laparoscopic Hernia Repair (rTAPP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Inguinal
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients who are scheduled for laparoscopic repair of a unilateral or bilateral inguinal hernia. A total of 50 patients will be enrolled in this observational study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: duration of the operation
timeFrame: from the start of the operation until the end of the operation, approximately 3 hours
Secondary outcomes:
measure: intra-operative complications
timeFrame: until 4 weeks post-operative
measure: post-operative complications
timeFrame: until 4 weeks post-operative
measure: Quality of Life
timeFrame: until 4 weeks post-operative
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
Study officials:
affiliation: Maria Middelares hospital
name: Filip Muysoms, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muysoms F, Van Cleven S, Kyle-Leinhase I, Ballecer C, Ramaswamy A. Robotic-assisted laparoscopic groin hernia repair: observational case-control study on the operative time during the learning curve. Surg Endosc. 2018 Dec;32(12):4850-4859. doi: 10.1007/s00464-018-6236-7. Epub 2018 May 15.