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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684448
• Other study ID #: ISI-IHR-2015-001
• Status: Completed
• Phase: N/A
• First received: February 12, 2016
• Last updated: March 27, 2017
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1258
• Est. completion date: January 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Inguinal Hernia Repair
Inguinal (unilateral or bilateral) hernia repair

Locations

Country	Name	City	State
United States	Progressive Surgical Associates/Silver Cross Hospital	New Lenox	Illinois
United States	Rochester General Hospital	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complications observed intraoperatively through 30-days		Intraoperative through 30-days follow-up