NCT02715622

A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients

A Prospective, Multicenter Post-Market Study to Evaluate and Compare the Clinical Outcomes, Pain and Patient Quality of Life After Open, Laparoscopic or Robotic Assisted Hernia (Incisional and Inguinal) Repair

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 944 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair. The outcomes that will be collected include various routine clinical parameters, short term patient reported outcomes (quality of life, pain scores) and long term hernia recurrence information. Patients will be treated according to standard of care at the surgeon's institution and patients will be followed up to collect information related to complications information and patient satisfaction associated with the hernia repair procedure.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Hernia repair	Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice

Timeline

• Start date: 2016-04-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2016-03-22
• Last updated: 2023-03-01

Locations

17 sites across 1 country: United States