Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair

Hernia, Inguinal Clinical Trial

Official title: A Retrospective Multi-Center Study for Evaluation of Clinical Outcomes in Inguinal Hernia Repair

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Hernia, Inguinal, Direct
• Hernia, Inguinal, Indirect

• NCT number: NCT02684448
• Study type: Observational
• Source: Intuitive Surgical
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Completion date: January 2017