NCT02684448

Brief Summary

This multi-center, retrospective data collection study will evaluate the feasibility, safety and performance of the da Vinci® surgical system for patients who have undergone robotic-assisted inguinal hernia repair, as well as provide information about the learning curve associated with robotic-assisted (da Vinci®) inguinal hernia repair. In addition, this retrospective data collection study will evaluate the perioperative outcomes of robotic-assisted (da Vinci®) inguinal hernia repair and compare perioperative outcomes with those associated with open hernia repair by the same participating surgeon.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,258

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

February 12, 2016

Last Update Submit

March 27, 2017

Conditions

Hernia, InguinalHernia, Inguinal, DirectHernia, Inguinal, Indirect

Outcome Measures

Primary Outcomes (1)

  • Number of complications observed intraoperatively through 30-days

    Intraoperative through 30-days follow-up

Study Arms (2)

Robotic-Assisted Inguinal Hernia Repair

Subjects who have undergone robotic-assisted (da Vinci) inguinal hernia repair from the initiation of robotic-assisted hernia repair at site through December 2015.

Procedure: Inguinal Hernia Repair

Open Inguinal Hernia Repair

Subjects who have undergone open inguinal hernia repair from the day prior to initiation of robotic-assisted hernia repair through 5 years prior to initiation.

Procedure: Inguinal Hernia Repair

Interventions

Inguinal Hernia RepairPROCEDURE

Inguinal (unilateral or bilateral) hernia repair

Also known as: Herniorrhaphy
Open Inguinal Hernia RepairRobotic-Assisted Inguinal Hernia Repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects who have undergone robotic-assisted inguinal hernia repair or open hernia repair per specified time frame described in inclusion/exclusion criteria

You may qualify if:

  • all patients who have undergone inguinal hernia repair using either an open technique or a robotic-assisted (da Vinci®) approach
  • Robotic-assisted (da Vinci®) hernia repair - all consecutive robotic cases from the initiation of robotic -assisted inguinal hernia repair at each institution until 30 days prior to the date of study initiation (IRB approval and fully executed contract).
  • Open hernia repair - all consecutive open hernia repair cases from the day prior to the 1st da Vinci® inguinal hernia repair until the number of open repair cases collected is equivalent to the number of da Vinci® cases entered, or the date 5 years pre-robotic initiation is reached.

You may not qualify if:

  • Subjects who have undergone robotic-assisted or open inguinal hernia repair outside of required timeframe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Progressive Surgical Associates/Silver Cross Hospital

New Lenox, Illinois, 60451, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Related Publications (1)

  • Dickens EO, Kolachalam R, Gonzalez A, Richardson C, D'Amico L, Rabaza J, Gamagami R. Does robotic-assisted transabdominal preperitoneal (R-TAPP) hernia repair facilitate contralateral investigation and repair without compromising patient morbidity? J Robot Surg. 2018 Dec;12(4):713-718. doi: 10.1007/s11701-018-0815-4. Epub 2018 Apr 30.

    PMID: 29713930DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2016

First Posted

February 18, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

January 1, 2017

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations

US(2)