Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair

NCT ID: NCT02684448

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1258 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-01-31

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.

Detailed Description

This study is a retrospective data collection from existing medical records, is observational in nature and is designed to evaluate feasibility, safety and performance of the da Vinci® surgical system for patients who have undergone inguinal hernia repair surgery during the time period from initiation of robotic-assisted surgery to 30 days prior to study initiation (IRB approval and fully executed data collection agreement) for approximately 500 subjects. Any inguinal hernia repair procedure that uses the da Vinci® surgical system at any point will be collected.

This data will be compared with data associated with open inguinal hernia repairs performed by the same surgeons from a period of 5 years prior to the initiation of robotic surgery at each participating institution until 30 days prior to study initiation. Sites will collect data from consecutive open inguinal hernia repair cases starting with the day prior to the 1st robotic-assisted inguinal hernia repair, and continue collecting data until the number of open inguinal hernia repair cases is equivalent to the number of robotic-assisted inguinal hernia repair cases, or until the open repair procedure date reaches 5 years prior to the 1st robotic-assisted inguinal hernia repair case.

Data collected will include, but is not limited to, the following:

1. Demographics and baseline/pre-operative clinical parameters: Gender, age, BMI, comorbidities, smoking history, prior hernia history, prior abdominal surgery history, hernia description

2. Intraoperative parameters: procedure details related to repair, operative time, conversions to open, blood loss, intraoperative complications

3. Post-operative through discharge : length of hospital stay, post-operative complications

4. Post-operative information regarding complications, readmissions and reoperations through 30 days post-discharge.

5. Hernia Recurrence, if available

The total duration for this study will be approximately 12 months

Conditions

Hernia, Inguinal; Hernia, Inguinal, Direct; Hernia, Inguinal, Indirect

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Inguinal Hernia Repair

Intervention Type: PROCEDURE

Inguinal (unilateral or bilateral) 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.

Inguinal Hernia Repair

Intervention Type: PROCEDURE

Inguinal (unilateral or bilateral) hernia repair

Interventions

Inguinal Hernia Repair

Inguinal (unilateral or bilateral) hernia repair

Intervention Type: PROCEDURE

Other Intervention Names

Herniorrhaphy

Eligibility Criteria

Inclusion Criteria

all patients who have undergone inguinal hernia repair using either an open technique or a robotic-assisted (da Vinci®) approach

Eligible subjects must have had their inguinal hernia repair completed according to the following timeframes for inclusion:

1. 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).

2. 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intuitive Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Progressive Surgical Associates/Silver Cross Hospital

New Lenox, Illinois, United States

Rochester General Hospital

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29713930 (View on PubMed)

Other Identifiers

ISI-IHR-2015-001

Identifier Type: -

Identifier Source: org_study_id