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Robotic Utility for Surgical Treatment of Groin Hernias

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02975401
Acronym
Robust _1
Enrollment
50
Registered
2016-11-29
Start date
2016-09-30
Completion date
2017-05-31
Last updated
2017-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Inguinal

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.

Interventions

PROCEDURErTAPP technique

robot-assisted rTAPP technique

Sponsors

Algemeen Ziekenhuis Maria Middelares
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
duration of the operationfrom the start of the operation until the end of the operation, approximately 3 hoursRecording of the operation time needed for robot-assisted TAPP groin hernia repair

Secondary

MeasureTime frameDescription
intra-operative complicationsuntil 4 weeks post-operativeIntra-operative complications registered until 4 weeks post-operative
post-operative complicationsuntil 4 weeks post-operativePost-operative complications detected until 4 weeks after hernia repair by clinical follow up.
Quality of Lifeuntil 4 weeks post-operativeQuality of Life measured with the EuraHS QoL score preoperative and until 4 weeks after hernia repair by clinical follow up.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026