Patient Reported Measures of Surgical Recovery
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Sponsor Protocol Number: 16-001576
About this study
Surgeons use the absence of post-operative complications and a short hospital stay as a proxy for successful surgery and recovery. Patients define recovery as ‘return to normal’, which encompasses their overall quality of life (QOL), physical and mental well-being, social functioning, and the absence of pain or fatigue, also known as patient reported outcomes (PROs). The Patient Reported Outcomes Measurement Information System (PROMIS) and the 10 point Linear Analogue Self- Assessment Questionnaire (LASA) tools are both candidates for effective, easily accessible measures of patient recovery after surgery. The purpose of this study is to define which PROMIS sub-scores and individual LASA measures are most responsive to perioperative changes in gastrointestinal surgery by assessing outcomes scores during patient short- and long-term recovery.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients ≥ 18 years of age
- ASA 1-4
- Undergoing laparoscopic or open gastrointestinal surgery (esophagectomy, pancreaticoduodenectomy, colectomy, or proctectomy)
- Willing to consent for the study
Exclusion criteria:
- Patients < 18 years
- ASA 5
- Patients unable or unwilling to consent
- Patients with acute psychiatric illness
- Patients with cancer undergoing palliative surgery without curative intent
More information
Publications
Publications are currently not available