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

Intuitive Surgical

Status: Completed

Conditions: Hernia, Inguinal, Direct; Incisional Hernia; Hernia, Inguinal, Indirect; Hernia; Inguinal Hernia

Treatments: Procedure: Hernia repair

Study type: Observational

Funder types: Industry

Identifiers

NCT02715622

ISI-PHS-2016

Details and patient eligibility

About

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.

Enrollment: 944 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years and older
2. All patients undergoing either an open, laparoscopic or robotic-assisted
3. Incisional or Inguinal Hernia repair procedure
4. Non-Emergent Incisional or Inguinal Hernia Repair cases

Exclusion criteria

1. Emergent Cases for both Incisional and Inguinal Hernia
2. Incisional Hernia related to ostomy formation
3. Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)

Trial design

944 participants in 3 patient groups

Open Hernia Repair

Description:

A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia open repair surgical procedure

Treatment:

Procedure: Hernia repair

Laparoscopic Hernia Repair

Description:

A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia laparoscopic repair surgical procedure

Treatment:

Procedure: Hernia repair

Robotic Hernia Repair

Description:

A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia robotic-assisted laparoscopic repair surgical procedure

Treatment:

Procedure: Hernia repair