Robotic Utility for Surgical Treatment of Groin Hernias

NCT ID: NCT02975401

Last Updated: 2017-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Hernia, Inguinal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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rTAPP technique

robot-assisted rTAPP technique

Intervention Type PROCEDURE

Other Intervention Names

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laparoscopic robot-assisted TAPP technique

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Algemeen Ziekenhuis Maria Middelares

OTHER

Sponsor Role lead

Responsible Party

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Filip Muysoms

surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filip Muysoms, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maria Middelares hospital

Locations

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AZ Maria Middelares

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 29766308 (View on PubMed)

Other Identifiers

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Robust_1

Identifier Type: -

Identifier Source: org_study_id

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