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OpenTrials
Completed

NCT Number: NCT02715622

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

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.

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Key information

Conditions

Hernia Hernia, Abdominal Hernia, Inguinal Hernia, Inguinal, Direct Hernia, Inguinal, Indirect Incisional Hernia Inguinal Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beverly Hills Hernia Center, Beverly Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hernia repair

Procedure

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

Primary outcomes

  1. Number of complications observed intraoperatively through 30 days

    Time frame: 30 days

    Number of intraoperative and short-term complications related to hernia repair.

  2. Number of patient reported complications post 30-days through 3 years post procedure

    Time frame: 30 days post-procedure to 3 years post-procedure

    Number of long-term complications related to hernia repair directly reported by patients

Secondary outcomes

  1. Patient reported outcomes on Quality of Life through 1 year

    Time frame: Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life

    Use of quality of life questionnaires (Carolinas Comfort Scale or HerQles Abdominal Questionnaire) will be used to assess patient qualify of life pre-procedure and post-procedure through 1 year.

  2. Incisional or Inguinal Hernia Recurrence through 3 years

    Time frame: 30 days post-procedure through 3 years

    Number of hernia recurrences for each patient will be patient reported through 3 years post-procedure.

  3. Patient reported outcomes on post-procedure pain through 3 years

    Time frame: 2-4 weeks post-procedure through 3 years post-procedure

    Pain medication taken by patient (type, dosage and quantity of pills) will also be captured through patient reported methods. Unit of measure will be numerical count of pills take

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Collaborators

  • Accelovance

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2016
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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