Robotic Utility for Surgical Treatment of Groin Hernias | NCT02975401

Studies
Robotic Utility for Surgical Treatment of Groin Hernias

NCT02975401

Sponsor

Algemeen Ziekenhuis Maria Middelares

Status

Completed

Last Update Posted

Jul 25, 2017Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Hernia, Inguinal

Interventions

rTAPP technique

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Oct 24, 2016

First Submission Date that Met QC Criteria

Nov 23, 2016

First Posted Date

Nov 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2017

Last Update Posted Date

Jul 25, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Filip Muysoms, surgeon, Algemeen Ziekenhuis Maria MiddelaresPrincipal Investigator

Lead Sponsor

Algemeen Ziekenhuis Maria MiddelaresOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rTAPP technique	Procedure	robot-assisted rTAPP technique		laparoscopic robot-assisted TAPP technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
intra-operative complications	Intra-operative complications registered until 4 weeks post-operative	until 4 weeks post-operative
post-operative complications	Post-operative complications detected until 4 weeks after hernia repair by clinical follow up.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Filip Muysoms, MD, PhD	Maria Middelares hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AZ Maria Middelares		Ghent		9000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29766308	Derived	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.

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms